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

Windber Research Institute

Status: Completed

Conditions: Cardiovascular Diseases; Heart Diseases

Treatments: Behavioral: Dr. Dean Ornish Program for Reversing Heart Disease

Study type: Interventional

Funder types: Other

Identifiers

NCT01805492

WRI-03-03

MDA W81XWH-05-2-0075 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 422 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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422 participants in 2 patient groups

Intervention

Experimental group

Description:

Dr. Dean Ornish Program for Reversing Heart Disease

Treatment:

Behavioral: Dr. Dean Ornish Program for Reversing Heart Disease

Control

No Intervention group

Description:

Non-intervention controls retrospectively matched to intervention participants