Coronary Artery Disease (CAD), Coronary Stenosis
Conditions
Keywords
Coronary Artery Disease (CAD), Home-based Cardiac Rehabilitation, Mobile Health (mHealth), Coronary Stenosis, Non-calcified Plaque, Coronary Computed Tomography Angiography (CCTA)
Brief summary
This single-center, randomized controlled trial aims to evaluate the efficacy of a mobile internet-based, home-based cardiac rehabilitation program in patients with mild to moderate coronary artery stenosis. A total of 176 eligible participants will be randomized to receive either a personalized lifestyle intervention via a mobile platform or routine clinical care. The primary endpoint is the change in non-calcified coronary plaque volume, as measured by coronary computed tomography angiography (CTA) at 12 months. Participants will be followed for a total of 36 months to comprehensively assess the long-term impact of this digital lifestyle intervention on plaque progression and cardiovascular outcomes.
Interventions
BEHAVIORALmHealth-based Cardiac Rehabilitation Program
The intervention is a comprehensive, personalized cardiac rehabilitation program delivered via a mobile health (mHealth) platform. It consists of three core components: (1) Exercise Prescription: Personalized training plans aiming for 150 minutes of moderate-intensity aerobic exercise per week, combined with strength and flexibility training. (2) Nutritional Guidance: An initial offline nutritional assessment and personalized meal planning, followed by monthly online follow-ups and adjustments. (3) Psychological Support: Motivational interviewing and targeted psychological interventions provided as needed. Additionally, the program utilizes the mHealth platform to provide weekly online community supervision, progress tracking, and continuous health education to enhance patient compliance and engagement.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 1.Diagnosis of mild-to-moderate coronary artery stenosis: presence of plaque in any coronary artery causing mild (\<50%) or moderate (50%-69%) luminal stenosis. 2.Age between 18 and 70 years. 3.Asymptomatic during exercise or recovery phases of cardiopulmonary assessment, including absence of angina, ST-segment depression, or complex arrhythmias at rest or during exercise. 4.Normal troponin levels. 5.Provided signed informed consent.
Exclusion criteria
* 1\. Severe coronary artery stenosis. 2.Presence of severe respiratory or cardiovascular diseases (e.g., acute myocardial infarction, acute tachyarrhythmia, pulmonary edema, severe aortic stenosis). 3.Angina symptoms or signs during low-intensity exercise (\<5 METs) or recovery. 4.Complex arrhythmias at rest or during exercise. 5.Hemodynamic abnormalities during exercise (e.g., failure of systolic blood pressure or heart rate to increase, or a decrease in blood pressure with increased exercise workload). 6.Severe psychological disorders. 7.Left ventricular ejection fraction (LVEF) \< 40%. 8.Elevated troponin levels. 9.Inability to undergo cardiopulmonary exercise testing due to neuromuscular or musculoskeletal disorders. 10.Presence of other severe comorbidities. 11.Refusal to sign informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| chang in non-calcified plaque volume | Baseline and 12 months | The change in non-calcified plaque volume will be assessed and quantified using Coronary Computed Tomography Angiography (CCTA). |
Countries
China
Contacts
CONTACTXue Feng
CONTACTShumin Zhang
Outcome results
None listed