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

Primary Purpose

Heart Diseases, Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dr. Dean Ornish Program for Reversing Heart Disease
Sponsored by
Windber Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Diseases focused on measuring Heart diseases, Cardiovascular diseases, Lifestyle modification, Diet, Exercise

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Windber Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Dr. Dean Ornish Program for Reversing Heart Disease

Non-intervention controls retrospectively matched to intervention participants

Outcomes

Primary Outcome Measures

Change in body mass index
Change in BMI from baseline to 12 weeks and from baseline to 52 weeks

Secondary Outcome Measures

Change in blood pressure
Change in BP from baseline to 12 weeks and from baseline to 52 weeks
Change in lipids
Change in HDL-, LDL-, total cholesterol, and triglycerides from baseline to 12 weeks and from baseline to 52 weeks
Change in exercise capacity
Change in exercise capacity from baseline to 12 weeks and from baseline to 52 weeks

Full Information

First Posted
February 21, 2013
Last Updated
March 4, 2013
Sponsor
Windber Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01805492
Brief Title
Global Profiling of Gene and Protein Expression Associated With Coronary Heart Disease Reversal
Official Title
Global Profiling of Gene and Protein Expression Associated With Coronary Heart Disease Reversal
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Windber Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases, Cardiovascular Diseases
Keywords
Heart diseases, Cardiovascular diseases, Lifestyle modification, Diet, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
422 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Dr. Dean Ornish Program for Reversing Heart Disease
Arm Title
Control
Arm Type
No Intervention
Arm Description
Non-intervention controls retrospectively matched to intervention participants
Intervention Type
Behavioral
Intervention Name(s)
Dr. Dean Ornish Program for Reversing Heart Disease
Intervention Description
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 Outcome Measure Information:
Title
Change in body mass index
Description
Change in BMI from baseline to 12 weeks and from baseline to 52 weeks
Time Frame
Baseline, 12 weeks, 52 weeks
Secondary Outcome Measure Information:
Title
Change in blood pressure
Description
Change in BP from baseline to 12 weeks and from baseline to 52 weeks
Time Frame
Baseline, 12 weeks, 52 weeks
Title
Change in lipids
Description
Change in HDL-, LDL-, total cholesterol, and triglycerides from baseline to 12 weeks and from baseline to 52 weeks
Time Frame
Baseline, 12 weeks, 52 weeks
Title
Change in exercise capacity
Description
Change in exercise capacity from baseline to 12 weeks and from baseline to 52 weeks
Time Frame
Baseline, 12 weeks, 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darrell L Ellsworth, PhD
Organizational Affiliation
Windber Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Windber Medical Center
City
Windber
State/Province
Pennsylvania
ZIP/Postal Code
15963
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15539963
Citation
Ellsworth DL, O'Dowd SC, Salami B, Hochberg A, Vernalis MN, Marshall D, Morris JA, Somiari RI. Intensive lifestyle modification: impact on cardiovascular disease risk factors in subjects with and without clinical cardiovascular disease. Prev Cardiol. 2004 Fall;7(4):168-75. doi: 10.1111/j.1520-037x.2004.3332.x.
Results Reference
result
PubMed Identifier
18197071
Citation
Vizza J, Neatrour DM, Felton PM, Ellsworth DL. Improvement in psychosocial functioning during an intensive cardiovascular lifestyle modification program. J Cardiopulm Rehabil Prev. 2007 Nov-Dec;27(6):376-83; quiz 384-5. doi: 10.1097/01.HCR.0000300264.07764.84.
Results Reference
result
PubMed Identifier
19563671
Citation
Decewicz DJ, Neatrour DM, Burke A, Haberkorn MJ, Patney HL, Vernalis MN, Ellsworth DL. Effects of cardiovascular lifestyle change on lipoprotein subclass profiles defined by nuclear magnetic resonance spectroscopy. Lipids Health Dis. 2009 Jun 29;8:26. doi: 10.1186/1476-511X-8-26.
Results Reference
result
PubMed Identifier
22633795
Citation
Voeghtly LM, Neatrour DM, Decewicz DJ, Burke A, Haberkorn MJ, Lechak F, Patney HL, Vernalis MN, Ellsworth DL. Cardiometabolic risk reduction in an intensive cardiovascular health program. Nutr Metab Cardiovasc Dis. 2013 Jul;23(7):662-9. doi: 10.1016/j.numecd.2012.01.012. Epub 2012 May 26.
Results Reference
result
PubMed Identifier
24563419
Citation
Ellsworth DL, Croft DT Jr, Weyandt J, Sturtz LA, Blackburn HL, Burke A, Haberkorn MJ, McDyer FA, Jellema GL, van Laar R, Mamula KA, Chen Y, Vernalis MN. Intensive cardiovascular risk reduction induces sustainable changes in expression of genes and pathways important to vascular function. Circ Cardiovasc Genet. 2014 Apr;7(2):151-60. doi: 10.1161/CIRCGENETICS.113.000121. Epub 2014 Feb 21.
Results Reference
derived
Links:
URL
http://www.wriwindber.org/
Description
Windber Research Institute home page

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

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