NCT06424119招募中不适用
Multi-Center Randomized Study of Clinical and Inflammatory Outcomes in Intensive Cardiac Rehabilitation and Traditional Cardiac Rehabilitation Programs (CREDIBLE Study)
Pritikin ICR6 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2024年4月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 6
- 主要终点
- Readmission Rate Data
研究概览
简要总结
The goal of this prospective study is to evaluate whether the Intensive Cardiac Rehabilitation (ICR) program provides incremental benefits over the Traditional Cardiac Rehabilitation (TCR) program, defined by readmission costs. The study aims to confirm:
- That ICR is associated with better outcomes than TCR, defined as lower readmission costs, lower incidence of major adverse cardiovascular events (MACE), and improvement in biomarkers, epigenetic markers, and inflammatory markers.
- The addition of food to the ICR program will further improve these outcomes.
ICR-eligible participants
- Will be randomized into one of three groups: (1) ICR 72 session program with home-delivered C2life® supplied food, (2) ICR 72 session without C2life® supplied food, or (3) TCR 36 session program without C2life supplied food
- Biometric measurements and laboratory measurements will be performed at entry into the rehab intervention, discharge from rehab intervention, and at 6 months after discharge.
- Epigenetic measurements will be performed at admission and discharge from the rehab intervention
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients eligible for an Intensive Cardiac Rehabilitation (ICR) Program at each of the three study sites outline below, stratified by one of the following qualifying cardiovascular events, including myocardial infarction (STEMI and NSTEMI), angioplasty and stents, coronary artery bypass, surgical or percutaneous valve repair or replacement, and stable congestive heart failure with reduced ejection fraction of 35% or less.
排除标准
- •Anticipated life expectancy of under 2 years
- •Any co-morbidity that would limit participation in the study.
结局指标
主要结局
Readmission Rate Data
时间窗: Followup may extend up to 5 years for a post-hoc EMR analysis.
Readmission rate data will include: 1. Actual number of all cause readmissions 2. Days in hospital for each readmission 3. Cost of readmission. Stratification between all cause and cardiovascular readmissions will be performed as an additional sub-analysis.
次要结局
- Composite Total Readmission Rates(At 1 and 2 years)
- MACE(At 1 and 2 years.)
- Readmission Days(At 1 and 2 years)
- Dietary Inflammation Index (DII)(At admission, discharge from program (about 12 weeks), and 6 month post-discharge)
- Labs(At admission, discharge (about 12 weeks), and 6 months post-discharge)
- Epigenetic Biomarkers Performed by Prosper eDNA®(Buccal swab at admission and discharge (about 12 weeks))
研究者
研究点 (6)
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