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Cardiometabolic Risk in Cardiac Rehab

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Health Diagnostic Laboratory, Inc.

キーワード

概要

1. 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.
2. 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.

説明

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.

日付

最終確認済み: 01/31/2015
最初に提出された: 11/04/2013
提出された推定登録数: 11/07/2013
最初の投稿: 11/14/2013
最終更新が送信されました: 02/11/2015
最終更新日: 02/12/2015
実際の研究開始日: 09/30/2013
一次完了予定日: 02/28/2015
研究完了予定日: 02/28/2015

状態または病気

Coronary Artery Disease

段階

-

適格基準

研究の対象となる年齢 18 Years に 18 Years
研究に適格な性別All
サンプリング方法Non-Probability Sample
健康なボランティアを受け入れるはい
基準

Inclusion Criteria:

- Known CAD/ IHD

- Eligibility for cardiac rehab following an acute coronary event; either:

- ST elevation myocardial infarction

- Non ST elevation myocardial infarction

- Angina

- CABG

Exclusion Criteria:

- Younger than 18 years old

結果

主な結果の測定

1. Cardiometabolic biomarker risk factor [Change from Baseline at 3 months]

二次的な結果の測定

1. Major adverse cardiovascular events [one year]

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