Effect of Mobile Internet Technology-Based Home Cardiac Rehabilitation on Coronary Artery Plaque in Patients With Mild to Moderate Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- chang in non-calcified plaque volume
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental Group
Participants receiving the home-based cardiac rehabilitation program via a mobile application.
干预措施: mHealth-based Cardiac Rehabilitation Program (Behavioral)
Control Group
Participants receiving usual care and general health education
结局指标
主要结局
chang in non-calcified plaque volume
时间窗: Baseline and 12 months
The change in non-calcified plaque volume will be assessed and quantified using Coronary Computed Tomography Angiography (CCTA).
次要结局
未报告次要终点