ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01805492
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01805492
Recruitment Status : Completed
First Posted : March 6, 2013
Last Update Posted : March 6, 2013
Sponsor:
Information provided by (Responsible Party):
Darrell L Ellsworth, 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.

Condition or disease Intervention/treatment Phase
Heart Diseases Cardiovascular Diseases Behavioral: Dr. Dean Ornish Program for Reversing Heart Disease Not Applicable

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  (Clinical Trial)
Actual Enrollment : 422 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Global Profiling of Gene and Protein Expression Associated With Coronary Heart Disease Reversal
Study Start Date : January 2000
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications of Results:
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 ( Other Grant/Funding Number: Department of Defense )
First Posted: March 6, 2013    Key Record Dates
Last Update Posted: March 6, 2013
Last Verified: March 2013

Keywords provided by Darrell L Ellsworth, Windber Research Institute:
Heart diseases
Cardiovascular diseases
Lifestyle modification
Diet
Exercise

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