Status:
ENROLLING_BY_INVITATION
Efficacy of the Integration of Digital Therapeutics and Home-based Cardiac Rehabilitation in High-Risk Post-PCI Patients
Lead Sponsor:
West China Hospital
Conditions:
Coronary Artery Disease
Myocardial Infarction
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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-mont...
Eligibility Criteria
Inclusion
- To be eligible to participate in this study, a participant must meet all of the following criteria:
- Women or men, the ages of 18 and 75 years.
- Have sufficient reading and writing language skills in Chinese.
- Be willing to participate the study and sign informed consent.
- Patients must have at least one clinical feature and one angiographic feature:
- 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
- A potential participant who meets any of the following criteria will be excluded from participation in this study:
- Contraindications to exercise rehabilitation (e.g., untreated ventricular tachycardia, severe heart failure (New York Heart Association class III or IV heart failure, or ejection fraction \< 40%), uncontrolled hypertension or hypotension, active hemorrhage, severe liver failure, significant exercise limitations).
- Vision, hearing, cognition-related or mental impairment leading to inability to cooperate.
- Patients with established planned Phase II PCI.
- Having pre-existing comorbid disease with a life expectancy of \< 1 year.
- Poor compliance and unable to complete the expected follow-up.
- Unable to access WeChat via a smartphone after training.
Key Trial Info
Start Date :
December 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
366 Patients enrolled
Trial Details
Trial ID
NCT06542575
Start Date
December 4 2024
End Date
May 1 2026
Last Update
January 14 2025
Active Locations (1)
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1
West China Hospital
Chengdu, Sichuan, China, 610041