Clinical trial NCT06542575: Efficacy of the Integration of Digital Therapeutics and Home-based Cardiac Rehabilitation in High-Risk Post-PCI Patients
Official title: Efficacy of the Integration of Digital Therapeutics and Home-based Cardiac Rehabilitation in High-Risk Post-PCI Patients on Cardiovascular Health
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Coronary Artery Disease
Myocardial Infarction
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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-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.


Eligibility criteria: Inclusion Criteria:

* To be eligible to participate in this study, a participant must meet all of the following criteria:

  1. Women or men, the ages of 18 and 75 years.
  2. Have sufficient reading and writing language skills in Chinese.
  3. Be willing to participate the study and sign informed consent.
  4. 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 Criteria:

* A potential participant who meets any of the following criteria will be excluded from participation in this study:

  1. 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).
  2. Vision, hearing, cognition-related or mental impairment leading to inability to cooperate.
  3. Patients with established planned Phase II PCI.
  4. Having pre-existing comorbid disease with a life expectancy of \< 1 year.
  5. Poor compliance and unable to complete the expected follow-up.
  6. Unable to access WeChat via a smartphone after training.

Primary outcomes:
measure: Change in 6-minute walk distance (i.e., functional capacity) at 6 months post randomization
timeFrame: At 6 months post randomization
Secondary outcomes:
measure: Change in functional capacity at 3 months postrandomization
timeFrame: At 3 months postrandomization
measure: Change in conventional CVD risk factors at 3, 6 months post randomization
timeFrame: At 3, 6 months post randomization
measure: Change in quality of life at 3, 6 months post randomization
timeFrame: At 3, 6 months post randomization
measure: Change in psychological status at 3, 6 months post randomization
timeFrame: At 3, 6 months post randomization
measure: Change in physical activity levels at 3, 6 months post randomization
timeFrame: At 3, 6 months post randomization
measure: Change in medication adherence at 3, 6 months post randomization
timeFrame: At 3, 6 months post randomization
Other outcomes:
measure: The incidence of major adverse cardiovascular events (MACEs) at 1 year post randomization
timeFrame: At 1 year post randomization
measure: User satisfaction
timeFrame: At 6 months post randomization
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
References: