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Trial record 12 of 20089 for:    heart disease

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

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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

Tracking Information
First Submitted Date  ICMJE February 21, 2013
First Posted Date  ICMJE March 6, 2013
Last Update Posted Date March 6, 2013
Study Start Date  ICMJE January 2000
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2013)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Global Profiling of Gene and Protein Expression Associated With Coronary Heart Disease Reversal
Official Title  ICMJE Global Profiling of Gene and Protein Expression Associated With Coronary Heart Disease Reversal
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.
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  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Diseases
  • Cardiovascular Diseases
Intervention  ICMJE 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.
Study Arms
  • Experimental: Intervention
    Dr. Dean Ornish Program for Reversing Heart Disease
    Intervention: Behavioral: Dr. Dean Ornish Program for Reversing Heart Disease
  • No Intervention: Control
    Non-intervention controls retrospectively matched to intervention participants
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2013)
422
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01805492
Other Study ID Numbers  ICMJE WRI-03-03
MDA W81XWH-05-2-0075 ( Other Grant/Funding Number: Department of Defense )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Darrell L Ellsworth, Windber Research Institute
Study Sponsor  ICMJE Windber Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Darrell L Ellsworth, PhD Windber Research Institute
PRS Account Windber Research Institute
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP