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OpenTrials
Completed

NCT Number: NCT01805492

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

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.

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Key information

Conditions

Heart Diseases Behavior Cardiovascular Diseases Motor Activity

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Windber Medical Center

Windber, Pennsylvania, 15963, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dr. Dean Ornish Program for Reversing Heart Disease

Behavioral

Prospective, nonrandomized clinical intervention to stabilize or reverse progression of heart disease through changes in lifestyle. Lifestyle intervention consisted of four components: 1) a very low fat vegetarian diet (<10% of calories from fat); 2) 180 minutes/week of moderate aerobic exercise; 3) one hour of stress management each day; and 4) weekly group support sessions.

Primary outcomes

  1. Change in body mass index

    Time frame: Baseline, 12 weeks, 52 weeks

    Change in BMI from baseline to 12 weeks and from baseline to 52 weeks

Secondary outcomes

  1. Change in blood pressure

    Time frame: Baseline, 12 weeks, 52 weeks

    Change in BP from baseline to 12 weeks and from baseline to 52 weeks

  2. Change in lipids

    Time frame: Baseline, 12 weeks, 52 weeks

    Change in HDL-, LDL-, total cholesterol, and triglycerides from baseline to 12 weeks and from baseline to 52 weeks

  3. Change in exercise capacity

    Time frame: Baseline, 12 weeks, 52 weeks

    Change in exercise capacity from baseline to 12 weeks and from baseline to 52 weeks

Sponsors and collaborators

Lead sponsor

Windber Research Institute

Other

Registry information

Important dates

Study start
2000
Primary completion
2009
Study completion
2009
First posted
Mar 6, 2013
Registry last updated
Mar 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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