← Back to Search

A Prospective Evaluation of Health Services Outcomes and Emerging Cardiovascular Disease Biomarkers

N/A
Waitlist Available
Led By Dean Ornish, MD
Research Sponsored by Preventive Medicine Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

The primary aim of the proposed research is to examine the relationship of lifestyle changes to new dietary, biomedical, and cellular parameters among new enrollees entering the "Dr. Dean Ornish Program for Reversing Heart Disease program" at 5 selected sites. Specifically, the investigators will add assessments of emerging cardiac risk factors (e.g., high sensitivity C-reactive protein \[hsCRP\], fibrinogen, lipoprotein(a) \[Lp(a)\], small, dense LDL, apolipoprotein B \[apoB\], apolipoprotein A-I \[apo A1\], the apoB/apoA1 ratio, homocysteine \[Hcy\], B-type natriuretic peptide \[BNP\], oxidized LDL, fasting insulin and waist-to-hip ratio \[WHR\]), protective and pathogenic dietary markers (e.g., folate, carotenoids, trans fatty acids), and measures of social support and cognitive functioning to the already existing assessment variables in the Multisite Cardiac Lifestyle Intervention Program (MCLIP). Hypothesis 1: Participation in the lifestyle program will not only be associated with favorable changes in standard coronary risk factors and quality of life, but also with improvements in emerging cardiac risk factors \[hsCRP, Hcy, BNP, fibrinogen, Lp(a), small, dense LDL, apoB, apoA1, oxidized LDL, fasting insulin, and abdominal obesity\] and psychosocial well-being (i.e., social support, and cognitive functioning). Hypothesis 2: High intake of emerging protective dietary factors and low intake of emerging pathogenic dietary factors will be associated with improvements in both standard and emerging cardiac risk factors (e.g. Hcy, oxidized LDL). Hypothesis 3: Degree of adherence to the lifestyle change program will be associated with differential improvement in standard coronary risk factors, emerging risk factors, cellular aging, and psychosocial variables.

Eligible Conditions
  • Coronary Heart Disease
  • Cardiovascular Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lifestyle InterventionExperimental Treatment1 Intervention
Comprehensive lifestyle intervention for reversal of heart disease
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dr. Dean Ornish Program for Reversing Heart Disease
2000
N/A
~430

Find a Location

Who is running the clinical trial?

Preventive Medicine Research InstituteLead Sponsor
1 Previous Clinical Trials
51 Total Patients Enrolled
Dean Ornish, MDPrincipal InvestigatorPreventive Medicine Research Institute
1 Previous Clinical Trials
51 Total Patients Enrolled
Edward Kersh, MD, FACCPrincipal InvestigatorSt. Luke's Hospital/California Pacific Cardiovascular Medical Group, Inc
Gerdi Weidner, PhDPrincipal InvestigatorPreventive Medicine Research Institute
Nita Chainani-Wu, DMD, MS, PhDStudy DirectorPreventive Medicine Research Institute
2 Previous Clinical Trials
75 Total Patients Enrolled
~7 spots leftby Dec 2025