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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Darrell L Ellsworth, Windber Research Institute
ClinicalTrials.gov Identifier:
NCT01805492
First received: February 21, 2013
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Heart Diseases
Cardiovascular Diseases
Behavioral: Dr. Dean Ornish Program for Reversing Heart Disease

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Global Profiling of Gene and Protein Expression Associated With Coronary Heart Disease Reversal

Resource links provided by NLM:


Further study details as provided by Windber Research Institute:

Primary Outcome Measures:
  • Change in body mass index [ Time Frame: Baseline, 12 weeks, 52 weeks ] [ Designated as safety issue: No ]
    Change in BMI from baseline to 12 weeks and from baseline to 52 weeks


Secondary Outcome Measures:
  • Change in blood pressure [ Time Frame: Baseline, 12 weeks, 52 weeks ] [ Designated as safety issue: No ]
    Change in BP from baseline to 12 weeks and from baseline to 52 weeks

  • Change in lipids [ Time Frame: Baseline, 12 weeks, 52 weeks ] [ Designated as safety issue: No ]
    Change in HDL-, LDL-, total cholesterol, and triglycerides from baseline to 12 weeks and from baseline to 52 weeks

  • Change in exercise capacity [ Time Frame: Baseline, 12 weeks, 52 weeks ] [ Designated as safety issue: No ]
    Change in exercise capacity from baseline to 12 weeks and from baseline to 52 weeks


Enrollment: 422
Study Start Date: January 2000
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01805492

Locations
United States, Pennsylvania
Windber Medical Center
Windber, Pennsylvania, United States, 15963
Sponsors and Collaborators
Windber Research Institute
Investigators
Principal Investigator: Darrell L Ellsworth, PhD Windber Research Institute
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Darrell L Ellsworth, Senior Director, Integrative Cardiac Health Program, Windber Research Institute
ClinicalTrials.gov Identifier: NCT01805492     History of Changes
Other Study ID Numbers: WRI-03-03, MDA W81XWH-05-2-0075
Study First Received: February 21, 2013
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Windber Research Institute:
Heart diseases
Cardiovascular diseases
Lifestyle modification
Diet
Exercise

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014