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Randomized Controlled Trial
Chronic remote ischemic conditioning treatment in patients with chronic stable angina (EARLY-MYO-CSA): a randomized, controlled proof-of-concept trial.
- Quan Guo, Zhenzhou Zhao, Fan Yang, Zhiwen Zhang, Xiaoyu Rao, Jing Cui, Qingbo Shi, Kaiyuan Liu, Kang Zhao, Haiyu Tang, Liang Peng, Cao Ma, Jun Pu, and Muwei Li.
- Department of Cardiology, Department of Coronary Heart Disease of Central China Fuwai Hospital, Henan Key Laboratory for Coronary Heart Disease, Central China Fuwai of Zhengzhou University, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, No. 1 Fuwai Road, Zhengzhou, Henan Province, China.
- Bmc Med. 2023 Aug 25; 21 (1): 324324.
BackgroundChronic remote ischemic conditioning (CRIC) has been shown to improve myocardial ischemia in experimental animal studies; however, its effectiveness in patients with chronic stable angina (CSA) has not been investigated. We conducted a proof-of-concept study to investigate the efficacy and safety of a six-month CRIC treatment in patients with CSA.MethodsThe EARLY-MYO-CSA trial was a prospective, randomized, controlled trial evaluating the CRIC treatment in patients with CSA with persistent angina pectoris despite receiving ≥ 3-month guideline-recommended optimal medical therapy. The CRIC and control groups received CRIC (at 200 mmHg) or sham CRIC (at 60 mmHg) intervention for 6 months, respectively. The primary endpoint was the 6-month change of myocardial flow reserve (MFR) on single-photon emission computed tomography. The secondary endpoints were changes in rest and stress myocardial blood flow (MBF), angina severity according to the Canadian Cardiovascular Society (CCS) classification, the Seattle Angina Questionnaire (SAQ), and a 6-min walk test (6-MWT).ResultsAmong 220 randomized CSA patients, 208 (105 in the CRIC group, and 103 in the control group) completed the treatment and endpoint assessments. The mean change in MFR was significantly greater in the CRIC group than in the control group (0.27 ± 0.38 vs. - 0.04 ± 0.25; P < 0.001). MFR increased from 1.33 ± 0.48 at baseline to 1.61 ± 0.53 (P < 0.001) in the CRIC group; however, a similar increase was not seen in the control group (1.35 ± 0.45 at baseline and 1.31 ± 0.44 at follow-up, P = 0.757). CRIC treatment, when compared with controls, demonstrated improvements in angina symptoms assessed by CCS classification (60.0% vs. 14.6%, P < 0.001), all SAQ dimensions scores (P < 0.001), and 6-MWT distances (440 [400-523] vs. 420 [330-475] m, P = 0.016). The incidence of major adverse cardiovascular events was similar between the groups.ConclusionsCSA patients benefit from 6-month CRIC treatment with improvements in MFR, angina symptoms, and exercise performance. This treatment is well-tolerated and can be recommended for symptom relief in this clinical population.Trial Registration[chictr.org.cn], identifier [ChiCTR2000038649].© 2023. BioMed Central Ltd., part of Springer Nature.
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