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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805492
• Other study ID #: WRI-03-03
• Secondary ID: MDA W81XWH-05-2-
• Status: Completed
• Phase: N/A
• First received: February 21, 2013
• Last updated: March 4, 2013
• Start date: January 2000
• Est. completion date: February 2009

Study information

• Verified date: March 2013
• Source: Windber Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 422
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
United States	Windber Medical Center	Windber	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Windber Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (4)

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 — View 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 — View 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.0000300264.0776 — View 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.num — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body mass index	Change in BMI from baseline to 12 weeks and from baseline to 52 weeks	Baseline, 12 weeks, 52 weeks	No
Secondary	Change in blood pressure	Change in BP from baseline to 12 weeks and from baseline to 52 weeks	Baseline, 12 weeks, 52 weeks	No
Secondary	Change in lipids	Change in HDL-, LDL-, total cholesterol, and triglycerides from baseline to 12 weeks and from baseline to 52 weeks	Baseline, 12 weeks, 52 weeks	No
Secondary	Change in exercise capacity	Change in exercise capacity from baseline to 12 weeks and from baseline to 52 weeks	Baseline, 12 weeks, 52 weeks	No

External Links

•   Windber Research Institute home page