NCT01985048Unknown不适用
Cardiometabolic Risk in the Setting of Cardiac Rehabilitation
Health Diagnostic Laboratory, Inc.3 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2013年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Cardiometabolic biomarker risk factor
研究概览
简要总结
- Primary Objectives:
- To characterize cardiometabolic risk factor profiles of patients entering cardiac rehab using traditional approaches (eg LDL-C) as well as a more comprehensive panel of cardiovascular and metabolic biomarkers. It is hypothesized that the comprehensive panel will identify further increased risk that would not have been detected using only traditional approaches. Specifically, it is hypothesized that a greater percentage of the cohort will be identified with "high risk" levels of LDL-P (>1100 nmol/L) and/or apoB (>80 mg/dL) than of LDL-C (>100 mg/dL). It is further hypothesized that the prevalence of elevated Lp(a) and elevated levels of inflammatory and insulin resistance markers will be higher in this cohort when compared to population norms (HDL, inc reference data).
- To assess improvements in laboratory and lifestyle risk factors and rate of goal attainment at completion of rehab (eg 3 months). This objective is primarily descriptive, and improvements in traditional risk factors (eg LDL-C) will be compared to existing published data. Improvements in non-traditional risk factors (eg LDL-P, insulin resistance markers) in a cardiac rehab population have not been extensively investigated.
- To determine which attributes at baseline best predicted recurrent events and re-hospitalizations assessed one year later.
- Secondary/Developmental Objective:
- To inform and guide development of a subsequent study protocol designed to compare outcomes associated with biomarker-guided personalized treatment plans vs. standard of care in the cardiac rehab setting.
详细描述
This pilot study will characterize risk factors of patients as they enter cardiac rehab, track how comprehensive biomarker profiles change during the normal course of rehab, and associate biomarkers at baseline with MACE outcomes assessed one year later. Blood draws, vitals, and patient medical histories will be collected as subjects enter rehab and at the end of the rehab program. Major adverse cardiac events will be assessed via phone interview at 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Known CAD/ IHD
- •Eligibility for cardiac rehab following an acute coronary event; either:
- •ST elevation myocardial infarction
- •Non ST elevation myocardial infarction
排除标准
- •Younger than 18 years old
结局指标
主要结局
Cardiometabolic biomarker risk factor
时间窗: Change from Baseline at 3 months
次要结局
- Major adverse cardiovascular events(one year)
研究者
研究点 (3)
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