Background: In outpatient center-based cardiac rehabilitation (O-CBCR), moderate-intensity continuous training (MICT) based on the anaerobic threshold (AT) determined by cardiopulmonary exercise stress testing is recommended. However, it is unclear whether differences in exercise intensity within the MICT domain affect peak oxygen uptake (%peakV̇O2). Methods and Results: We retrospectively evaluated patients who underwent O-CBCR at Japan Community Healthcare Organization Osaka Hospital. Those treated with the constant-load method were designated as Group A (n=38), whereas those treated with the variable-load method were designated as Group B (n=48). Although the change in exercise intensity was significantly greater in Group B by approximately 4.5 W, the change in %peakV̇O2 was not significantly different between groups. Group A had a significantly longer exercise time than Group B (by approximately 4-5 min). No deaths or hospitalizations occurred in either group. The percentage of episodes with exercise cessation was similar between the 2 groups, but the percentage of episodes with load reduction was significantly higher in Group B, mostly because of the increased heart rate. Conclusions: In supervised MICT based on AT, the variable-load method increased exercise intensity more than the constant-load method without severe complications, but did not improve %peakV̇O2.
{"title":"Effect of Constant vs. Variable Moderate-Intensity Load on Peak Oxygen Uptake in Outpatient Cardiac Rehabilitation.","authors":"Hajime Saeki, Miho Kuramoto, Yoshinori Iida, Kaori Yasumura, Yoh Arita, Nobuyuki Ogasawara","doi":"10.1253/circrep.CR-23-0024","DOIUrl":"10.1253/circrep.CR-23-0024","url":null,"abstract":"<p><p><b><i>Background:</i></b> In outpatient center-based cardiac rehabilitation (O-CBCR), moderate-intensity continuous training (MICT) based on the anaerobic threshold (AT) determined by cardiopulmonary exercise stress testing is recommended. However, it is unclear whether differences in exercise intensity within the MICT domain affect peak oxygen uptake (%peakV̇O<sub>2</sub>). <b><i>Methods and Results:</i></b> We retrospectively evaluated patients who underwent O-CBCR at Japan Community Healthcare Organization Osaka Hospital. Those treated with the constant-load method were designated as Group A (n=38), whereas those treated with the variable-load method were designated as Group B (n=48). Although the change in exercise intensity was significantly greater in Group B by approximately 4.5 W, the change in %peakV̇O<sub>2</sub> was not significantly different between groups. Group A had a significantly longer exercise time than Group B (by approximately 4-5 min). No deaths or hospitalizations occurred in either group. The percentage of episodes with exercise cessation was similar between the 2 groups, but the percentage of episodes with load reduction was significantly higher in Group B, mostly because of the increased heart rate. <b><i>Conclusions:</i></b> In supervised MICT based on AT, the variable-load method increased exercise intensity more than the constant-load method without severe complications, but did not improve %peakV̇O<sub>2</sub>.</p>","PeriodicalId":10276,"journal":{"name":"Circulation Reports","volume":"5 5","pages":"167-176"},"PeriodicalIF":0.0,"publicationDate":"2023-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/6f/63/circrep-5-167.PMC10166670.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9467651","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Rare Case of Acute Closed Type B Aortic Dissection Complicated by Giant Left Subclavian Artery Aneurysm.","authors":"Masashi Yanagisawa, Naoki Fujimoto, Satoshi Fujita, Takatoshi Higashigawa, Yu Shomura, Kaoru Dohi","doi":"10.1253/circrep.CR-23-0010","DOIUrl":"10.1253/circrep.CR-23-0010","url":null,"abstract":"","PeriodicalId":10276,"journal":{"name":"Circulation Reports","volume":"5 5","pages":"225-226"},"PeriodicalIF":0.0,"publicationDate":"2023-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/cb/79/circrep-5-225.PMC10166663.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9832895","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: The prognostic impact of CHADS2, CHA2DS2-VASc, and CHA2DS2-VASc-HS scores on clinical outcomes after drug-eluting stent (DES) placement has not been fully elucidated. Methods and Results: The present study was a retrospective, non-randomized, single-center, and lesion-based study. Target lesion failure (TLF), comprising cardiac death, non-fatal myocardial infarction, and target vessel revascularization, occurred in 7.1% of 872 consecutive de novo coronary lesions in 586 patients. These patients were electively and exclusively treated by DESs from January 2016 to January 2022 until July 2022 with a mean (±SD) observational interval of 411±438 days. Multivariate Cox proportional hazard analysis revealed that CHA2DS2-VASc-HS scores ≥7 (hazard ratio [HR] 1.800; 95% CI 1.06-3.05; P=0.029) was a significant predictor of cumulative TLF among 24 variables evaluated. CHADS2 scores ≥2 (HR 3.213; 95% CI 1.32-7.80; P=0.010) and CHA2DS2-VASc scores ≥5 (HR 1.980; 95% CI 1.10-3.55; P=0.022) were also significant in the multivariate analysis. Pairwise comparisons of receiver operating characteristic curves for CHADS2 score ≥2, CHA2DS2-VASc score ≥5, and CHA2DS2-VASc-HS score ≥7 showed they were equivalent in terms of predicting the incidence of TLF, with areas under the curve of 0.568, 0.575, and 0.573, respectively. Conclusions: All 3 cardiocerebrovascular thromboembolism risk scores were strong predictors of the incidence of cumulative mid-term TLF after elective DES placement, with cut-off values of 2, 5, and 7, respectively, and equivalent prognostic impacts.
背景:CHADS2、CHA2DS2-VASc 和 CHA2DS2-VASc-HS 评分对药物洗脱支架(DES)置入后临床预后的影响尚未完全阐明。方法和结果:本研究是一项回顾性、非随机、单中心和基于病变的研究。在 586 名患者的 872 个连续新发冠状动脉病变中,7.1% 的患者发生了靶病变失败(TLF),包括心源性死亡、非致死性心肌梗死和靶血管血运重建。这些患者在2016年1月至2022年1月直至2022年7月期间选择性地全部接受了DES治疗,平均(±SD)观察间隔为411±438天。多变量Cox比例危险分析显示,在24个评估变量中,CHA2DS2-VASc-HS评分≥7(危险比[HR]1.800;95% CI 1.06-3.05;P=0.029)是累积TLF的重要预测因素。CHADS2 评分≥2(HR 3.213;95% CI 1.32-7.80;P=0.010)和 CHA2DS2-VASc 评分≥5(HR 1.980;95% CI 1.10-3.55;P=0.022)在多变量分析中也具有显著性。对CHADS2评分≥2分、CHA2DS2-VASc评分≥5分和CHA2DS2-VASc-HS评分≥7分的接收者操作特征曲线进行配对比较后发现,它们在预测TLF的发生率方面相当,曲线下面积分别为0.568、0.575和0.573。结论所有三种心脑血管血栓栓塞风险评分都能很好地预测择期置入DES后累积中期TLF的发生率,截止值分别为2、5和7,对预后的影响相当。
{"title":"Prognostic Impacts of CHADS<sub>2</sub>, CHA<sub>2</sub>DS<sub>2</sub>-VASc, and CHA<sub>2</sub>DS<sub>2</sub>-VASc-HS Scores on Clinical Outcomes After Elective Drug-Eluting Stent Placement for De Novo Coronary Stenosis.","authors":"Tomoaki Ukaji, Tetsuya Ishikawa, Hidehiko Nakamura, Yukiko Mizutani, Kouta Yamada, Masatoshi Shimura, Yuki Kondo, Yohei Tamura, Yuri Koshikawa, Itaru Hisauchi, Shiro Nakahara, Yuji Itabashi, Sayuki Kobayashi, Isao Taguchi","doi":"10.1253/circrep.CR-22-0120","DOIUrl":"10.1253/circrep.CR-22-0120","url":null,"abstract":"<p><p><b><i>Background:</i></b> The prognostic impact of CHADS<sub>2</sub>, CHA<sub>2</sub>DS<sub>2</sub>-VASc, and CHA<sub>2</sub>DS<sub>2</sub>-VASc-HS scores on clinical outcomes after drug-eluting stent (DES) placement has not been fully elucidated. <b><i>Methods and Results:</i></b> The present study was a retrospective, non-randomized, single-center, and lesion-based study. Target lesion failure (TLF), comprising cardiac death, non-fatal myocardial infarction, and target vessel revascularization, occurred in 7.1% of 872 consecutive de novo coronary lesions in 586 patients. These patients were electively and exclusively treated by DESs from January 2016 to January 2022 until July 2022 with a mean (±SD) observational interval of 411±438 days. Multivariate Cox proportional hazard analysis revealed that CHA<sub>2</sub>DS<sub>2</sub>-VASc-HS scores ≥7 (hazard ratio [HR] 1.800; 95% CI 1.06-3.05; P=0.029) was a significant predictor of cumulative TLF among 24 variables evaluated. CHADS<sub>2</sub> scores ≥2 (HR 3.213; 95% CI 1.32-7.80; P=0.010) and CHA<sub>2</sub>DS<sub>2</sub>-VASc scores ≥5 (HR 1.980; 95% CI 1.10-3.55; P=0.022) were also significant in the multivariate analysis. Pairwise comparisons of receiver operating characteristic curves for CHADS<sub>2</sub> score ≥2, CHA<sub>2</sub>DS<sub>2</sub>-VASc score ≥5, and CHA<sub>2</sub>DS<sub>2</sub>-VASc-HS score ≥7 showed they were equivalent in terms of predicting the incidence of TLF, with areas under the curve of 0.568, 0.575, and 0.573, respectively. <b><i>Conclusions:</i></b> All 3 cardiocerebrovascular thromboembolism risk scores were strong predictors of the incidence of cumulative mid-term TLF after elective DES placement, with cut-off values of 2, 5, and 7, respectively, and equivalent prognostic impacts.</p>","PeriodicalId":10276,"journal":{"name":"Circulation Reports","volume":"5 4","pages":"123-132"},"PeriodicalIF":0.0,"publicationDate":"2023-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/91/fa/circrep-5-123.PMC10072895.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9272045","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
case of IE in the pulmonary valve that was detected by electrocardiography-gated cardiac computed tomography (CT). A 58-year-old man with a history of atopic dermatitis presented with sepsis. Blood cultures indicated the presI solated pulmonary valve endocarditis is a rare type of right-sided infective endocarditis (IE).1 Diagnosis of isolated pulmonary valve endocarditis is difficult using transthoracic and transesophageal echocardiography (TTE and TEE, respectively). Herein, we report a
{"title":"Evaluation of Pulmonary Valve Endocarditis by Electrocardiography-Gated Cardiac Computed Tomography.","authors":"Sayaka Funabashi, Takashi Kohno, Takato Mohri, Shinsuke Takeuchi, Toshinori Minamishima, Kenichi Yokoyama","doi":"10.1253/circrep.CR-23-0006","DOIUrl":"https://doi.org/10.1253/circrep.CR-23-0006","url":null,"abstract":"case of IE in the pulmonary valve that was detected by electrocardiography-gated cardiac computed tomography (CT). A 58-year-old man with a history of atopic dermatitis presented with sepsis. Blood cultures indicated the presI solated pulmonary valve endocarditis is a rare type of right-sided infective endocarditis (IE).1 Diagnosis of isolated pulmonary valve endocarditis is difficult using transthoracic and transesophageal echocardiography (TTE and TEE, respectively). Herein, we report a","PeriodicalId":10276,"journal":{"name":"Circulation Reports","volume":"5 3","pages":"99-100"},"PeriodicalIF":0.0,"publicationDate":"2023-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/03/ee/circrep-5-99.PMC9992499.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9095558","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-03-10DOI: 10.1253/circrep.CR-22-0076
Michihiro Suwa, Yuki Nohara, Isao Morii, Masaya Kino
Background: Off-label dosing of direct oral anticoagulants (DOAC) as a treatment for non-valvular atrial fibrillation (NVAF) is problematic. Here, we investigated the status of rivaroxaban and edoxaban dosing by monitoring plasma concentrations (PCs). Methods and Results: We monitored drug PCs in 391 and 333 outpatients receiving rivaroxaban and edoxaban, respectively, for NVAF. Drug doses were adjusted if the PC was above the cut-off value (rivaroxaban: 404 ng/mL; edoxaban: 402 ng/mL), determined from receiver operating characteristic curves for predicting bleeding events. On-label standard dosing was reduced to off-label underdosing due to high PCs above the cut-off more often for rivaroxaban (28.1%) than edoxaban (12.6%; P<0.001). Over a median follow-up of 13 months for rivaroxaban and 10 months for edoxaban, the annual incidence of bleeding events was higher with rivaroxaban than with edoxaban (4.88 vs. 3.73 patient-years; P<0.05), although no thromboembolic events occurred in either group. Furthermore, for patients with creatinine clearance >50 mL/min and body weight ≤60 kg, there was a greater incidence of bleeding events with rivaroxaban on-label 15 mg dosing than with edoxaban on-label 30 mg dosing (22.2% vs 2.9%; P<0.01). Conclusions: Monitoring the PCs of rivaroxaban and edoxaban in NVAF patients enables dose adjustments to reduce bleeding risk. The incidence of bleeding under drug PC monitoring was less in the edoxaban than rivaroxaban group.
背景:直接口服抗凝剂(DOAC)作为非瓣膜性房颤(NVAF)治疗的超说明书剂量是有问题的。在这里,我们通过监测血浆浓度(PCs)来研究利伐沙班和依多沙班的剂量状况。方法与结果:我们分别对391例和333例接受利伐沙班和依多沙班治疗非瓣膜性房颤的门诊患者进行药物PCs监测。如果PC高于临界值(利伐沙班:404 ng/mL;依多沙班:402 ng/mL),根据受试者工作特征曲线测定,用于预测出血事件。由于利伐沙班(28.1%)比依多沙班(12.6%)的pc值高于临界值,标签上的标准剂量减少到标签外的不足剂量;P50 mL/min,体重≤60 kg时,利伐沙班标签上15mg剂量组出血事件发生率高于标签上30mg剂量组(22.2% vs 2.9%;结论:监测非瓣膜性房颤患者利伐沙班和依多沙班的PCs可调整剂量以降低出血风险。药物PC监测下,依多沙班组出血发生率低于利伐沙班组。
{"title":"Safety and Efficacy Re-Evaluation of Edoxaban and Rivaroxaban Dosing With Plasma Concentration Monitoring in Non-Valvular Atrial Fibrillation: With Observations of On-Label and Off-Label Dosing.","authors":"Michihiro Suwa, Yuki Nohara, Isao Morii, Masaya Kino","doi":"10.1253/circrep.CR-22-0076","DOIUrl":"https://doi.org/10.1253/circrep.CR-22-0076","url":null,"abstract":"<p><p><b><i>Background:</i></b> Off-label dosing of direct oral anticoagulants (DOAC) as a treatment for non-valvular atrial fibrillation (NVAF) is problematic. Here, we investigated the status of rivaroxaban and edoxaban dosing by monitoring plasma concentrations (PCs). <b><i>Methods and Results:</i></b> We monitored drug PCs in 391 and 333 outpatients receiving rivaroxaban and edoxaban, respectively, for NVAF. Drug doses were adjusted if the PC was above the cut-off value (rivaroxaban: 404 ng/mL; edoxaban: 402 ng/mL), determined from receiver operating characteristic curves for predicting bleeding events. On-label standard dosing was reduced to off-label underdosing due to high PCs above the cut-off more often for rivaroxaban (28.1%) than edoxaban (12.6%; P<0.001). Over a median follow-up of 13 months for rivaroxaban and 10 months for edoxaban, the annual incidence of bleeding events was higher with rivaroxaban than with edoxaban (4.88 vs. 3.73 patient-years; P<0.05), although no thromboembolic events occurred in either group. Furthermore, for patients with creatinine clearance >50 mL/min and body weight ≤60 kg, there was a greater incidence of bleeding events with rivaroxaban on-label 15 mg dosing than with edoxaban on-label 30 mg dosing (22.2% vs 2.9%; P<0.01). <b><i>Conclusions:</i></b> Monitoring the PCs of rivaroxaban and edoxaban in NVAF patients enables dose adjustments to reduce bleeding risk. The incidence of bleeding under drug PC monitoring was less in the edoxaban than rivaroxaban group.</p>","PeriodicalId":10276,"journal":{"name":"Circulation Reports","volume":"5 3","pages":"80-89"},"PeriodicalIF":0.0,"publicationDate":"2023-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/30/e2/circrep-5-80.PMC9992501.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10195115","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-03-10DOI: 10.1253/circrep.CR-23-0002
Kotaro Horie, Teruhiko Imamura
collecting duct.3 It may be of great interest to investigate other predictors that are associated with the achievement of the primary endpoint in the study of Matsuda et al. The optimal timing to initiate tolvaptan is another concern. Matsuda et al initiated tolvaptan on postoperative Day 2. Earlier initiation of tolvaptan orally or intravenously may have more clinical benefit by increasing urine volume and maintaining renal function.4
{"title":"Optimal Patient Selection and Treatment Timing for Tolvaptan Therapy Following Cardiovascular Surgery.","authors":"Kotaro Horie, Teruhiko Imamura","doi":"10.1253/circrep.CR-23-0002","DOIUrl":"https://doi.org/10.1253/circrep.CR-23-0002","url":null,"abstract":"collecting duct.3 It may be of great interest to investigate other predictors that are associated with the achievement of the primary endpoint in the study of Matsuda et al. The optimal timing to initiate tolvaptan is another concern. Matsuda et al initiated tolvaptan on postoperative Day 2. Earlier initiation of tolvaptan orally or intravenously may have more clinical benefit by increasing urine volume and maintaining renal function.4","PeriodicalId":10276,"journal":{"name":"Circulation Reports","volume":"5 3","pages":"101"},"PeriodicalIF":0.0,"publicationDate":"2023-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/93/33/circrep-5-101.PMC9992502.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9095557","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-03-10DOI: 10.1253/circrep.CR-23-0014
Yasuhiro Matsuda, Tadaaki Koyama
predictor of the response to tolvaptan.6 In future, if possible, we would like to conduct a comparative study in a group of patients with poor renal function. However there is a high possibility that this group of patients will be treated with a combination of multiple drugs, such as other diuretics and carperitide, and it will therefore be difficult to evaluate the effects of tolvaptan alone.
{"title":"Optimal Patient Selection and Treatment Timing for Tolvaptan Therapy Following Cardiovascular Surgery - Reply.","authors":"Yasuhiro Matsuda, Tadaaki Koyama","doi":"10.1253/circrep.CR-23-0014","DOIUrl":"https://doi.org/10.1253/circrep.CR-23-0014","url":null,"abstract":"predictor of the response to tolvaptan.6 In future, if possible, we would like to conduct a comparative study in a group of patients with poor renal function. However there is a high possibility that this group of patients will be treated with a combination of multiple drugs, such as other diuretics and carperitide, and it will therefore be difficult to evaluate the effects of tolvaptan alone.","PeriodicalId":10276,"journal":{"name":"Circulation Reports","volume":"5 3","pages":"102"},"PeriodicalIF":0.0,"publicationDate":"2023-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/36/2b/circrep-5-102.PMC9992506.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9101528","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Clinical practice guidelines strongly recommend optimal medical therapy (OMT), including lifestyle modification, pharmacotherapy, and exercise-based cardiac rehabilitation (CR), in patients with stable ischemic heart disease (SIHD). However, the efficacy and safety of CR in patients with SIHD without revascularization remain unclear. Methods and Results: The Prospective Registry of STable Angina RehabiliTation (Pre-START) study is a multicenter, prospective, single-arm, open-label pilot study to evaluate the efficacy and safety of CR on health-related quality of life (HRQL), exercise capacity, and clinical outcomes in Japanese patients with SIHD without revascularization. In this study, all patients will undergo guideline-based OMT and are encouraged to have 36 outpatient CR sessions within 5 months after enrollment. The primary endpoint is the change in the Seattle Angina Questionnaire-7 summary score between baseline and the 6-month visit; an improvement of ≥5 points will be defined as a clinically important change. Secondary endpoints include changes in other HRQL scores and exercise capacity between baseline and the 6-month visit, as well as clinical outcomes between enrollment and the 6-month visit. Conclusions: The Pre-START study will provide valuable evidence to elucidate the efficacy and safety of CR in patients with SIHD and indispensable information for a subsequent randomized controlled trial. The study was registered with the University Hospital Medical Information Network (UMIN) Clinical Trials Registry (ID: UMIN000045415) on April 1, 2022.
{"title":"Cardiac Rehabilitation for Patients With Stable Ischemic Heart Disease Without Revascularization - Rationale and Design of a Single-Arm Pilot Study.","authors":"Tomotsugu Seki, Makoto Murata, Kensuke Takabayashi, Takashi Yanagisawa, Masayuki Ogihara, Ritsuko Kurimoto, Keisuke Kida, Koichi Tamita, Xiaoyang Song, Neiko Ozasa, Ryoji Taniguchi, Miho Nishitani-Yokoyama, Shinji Koba, Ryosuke Murai, Yutaka Furukawa, Maki Hamasaki, Hirokazu Kondo, Hironori Hayashi, Asako Ootakara-Katsume, Kento Tateishi, Satoaki Matoba, Hitoshi Adachi, Hirokazu Shiraishi","doi":"10.1253/circrep.CR-22-0131","DOIUrl":"https://doi.org/10.1253/circrep.CR-22-0131","url":null,"abstract":"<p><p><b><i>Background:</i></b> Clinical practice guidelines strongly recommend optimal medical therapy (OMT), including lifestyle modification, pharmacotherapy, and exercise-based cardiac rehabilitation (CR), in patients with stable ischemic heart disease (SIHD). However, the efficacy and safety of CR in patients with SIHD without revascularization remain unclear. <b><i>Methods and Results:</i></b> The Prospective Registry of STable Angina RehabiliTation (Pre-START) study is a multicenter, prospective, single-arm, open-label pilot study to evaluate the efficacy and safety of CR on health-related quality of life (HRQL), exercise capacity, and clinical outcomes in Japanese patients with SIHD without revascularization. In this study, all patients will undergo guideline-based OMT and are encouraged to have 36 outpatient CR sessions within 5 months after enrollment. The primary endpoint is the change in the Seattle Angina Questionnaire-7 summary score between baseline and the 6-month visit; an improvement of ≥5 points will be defined as a clinically important change. Secondary endpoints include changes in other HRQL scores and exercise capacity between baseline and the 6-month visit, as well as clinical outcomes between enrollment and the 6-month visit. <b><i>Conclusions:</i></b> The Pre-START study will provide valuable evidence to elucidate the efficacy and safety of CR in patients with SIHD and indispensable information for a subsequent randomized controlled trial. The study was registered with the University Hospital Medical Information Network (UMIN) Clinical Trials Registry (ID: UMIN000045415) on April 1, 2022.</p>","PeriodicalId":10276,"journal":{"name":"Circulation Reports","volume":"5 3","pages":"90-94"},"PeriodicalIF":0.0,"publicationDate":"2023-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/9e/44/circrep-5-90.PMC9992498.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9095556","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}