Global Profiling of Gene and Protein Expression Associated With Coronary Heart Disease Reversal

Not Applicable

Completed

• Conditions: Heart Diseases; Cardiovascular Diseases

• Registration Number: NCT01805492
• Lead Sponsor: Windber Research Institute

Brief Summary

The purpose of this study is to characterize changes in gene and protein expression in peripheral blood in patients with, or at risk for, heart disease during an intensive lifestyle modification program.

Detailed Description

This project will use an integrated approach that examines DNA variation and the functional products of genes at both the messenger RNA (mRNA) and protein levels to provide a global view of molecular changes associated with drastic lifestyle modifications designed to reverse coronary heart disease (CHD). DNA variants and/or changes in gene and protein expression associated with CHD reversal may provide important clues to understanding molecular mechanisms of subclinical CHD development and progression.

Study Timeline

• Study Start: 2000-01
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Study First Submitted: 2013-02-21
• Status Verified: 2013-03
• Study First Submitted QC: 2013-03-04
• Last Update Submitted: 2013-03-04
• Study First Posted: 2013-03-06
• Last Update Posted: 2013-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 422

Inclusion Criteria

• diagnosis of coronary artery disease (CAD)
• stable angina
• angioplasty
• evidence of >50% luminal narrowing on coronary angiogram
• acute myocardial infarction
• bypass surgery
• stent placement OR
• two or more CAD risk factors
• systolic pressure >140 mm Hg or diastolic pressure >90 mm Hg)
• high total cholesterol (>200 mg/dL)
• physician diagnosed diabetes
• body mass index (BMI) >30
• family history of heart disease in parents or siblings
• 21 years of age or older
• mentally competent to provide informed consent

Exclusion Criteria

• known history of autoimmune disease
• systemic/chronic disease requiring chemotherapy or long term treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in body mass index	Baseline, 12 weeks, 52 weeks	Change in BMI from baseline to 12 weeks and from baseline to 52 weeks

Secondary Outcome Measures

Name	Time	Method
Change in blood pressure	Baseline, 12 weeks, 52 weeks	Change in BP from baseline to 12 weeks and from baseline to 52 weeks
Change in lipids	Baseline, 12 weeks, 52 weeks	Change in HDL-, LDL-, total cholesterol, and triglycerides from baseline to 12 weeks and from baseline to 52 weeks
Change in exercise capacity	Baseline, 12 weeks, 52 weeks	Change in exercise capacity from baseline to 12 weeks and from baseline to 52 weeks

Trial Locations

Locations (1)

Windber Medical Center; 🇺🇸 Windber, Pennsylvania, United States