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

March 4, 2013 updated by: Darrell L Ellsworth, Windber Research Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

422

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Windber, Pennsylvania, United States, 15963
        • Windber Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Dr. Dean Ornish Program for Reversing Heart Disease
Behavioral: Dr. Dean Ornish Program for Reversing Heart Disease
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.
No Intervention: Control
Non-intervention controls retrospectively matched to intervention participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 12 weeks, 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 12 weeks, 52 weeks
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
Baseline, 12 weeks, 52 weeks
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
Baseline, 12 weeks, 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Windber Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

February 21, 2013

First Submitted That Met QC Criteria

March 4, 2013

First Posted (Estimate)

March 6, 2013

Study Record Updates

Last Update Posted (Estimate)

March 6, 2013

Last Update Submitted That Met QC Criteria

March 4, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WRI-03-03
  • MDA W81XWH-05-2-0075 (Other Grant/Funding Number: Department of Defense)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Diseases

Clinical Trials on Dr. Dean Ornish Program for Reversing Heart Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe