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The DTx-HBCR trial will randomize 366 high-risk patients who undergo PCI at the West China Hospital of Sichuan University to either the 6-month DTx-guided HBCR group (intervention group) or the 6-months usual care group (control group) in a parallel-arm randomized controlled trial. The primary outcome is the difference between the intervention group and control group in walk distance on the 6-minute walk test (i.e., functional capacity) at 6 months post randomization. The key secondary outcomes include improvements in cardiovascular risk factor control, quality of life, psychological status, physical activity, major adverse cardiovascular events, and medication adherence. This study aims to evaluate the DTx-guided HBCR, a software-driven, multidisciplinary health intervention as an alternative to traditional in-center CR in patients with high-risk patients following percutaneous coronary intervention (PCI) compared with usual care alone.
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Inclusion criteria
To be eligible to participate in this study, a participant must meet all of the following criteria:
A. Clinical features: age ≥ 65 years, female sex, troponin positive acute coronary syndrome, established vascular disease (prior myocardial infarction, coronary revascularization or peripheral arterial disease) , diabetes mellitus requiring medication and chronic kidney disease (estimated glomerular filtration rate < 60 ml/min/1.73 m2 or creatinine clearance < 60 cc/min) .
B. Angiographic features: multivessel coronary artery disease, total stent length > 30 mm, thrombotic target lesion, bifurcation lesion requiring two stents, obstructive left main or proximal left anterior descending lesion and calcified target lesion requiring atherectomy.
Exclusion criteria
A potential participant who meets any of the following criteria will be excluded from participation in this study:
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366 participants in 2 patient groups
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Central trial contact
Zhongxiu Chen, MD
Data sourced from clinicaltrials.gov
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