Status:
UNKNOWN
A Prospective Evaluation of Health Services Outcomes and Emerging Cardiovascular Disease Biomarkers
Lead Sponsor:
Preventive Medicine Research Institute
Conditions:
Coronary Heart Disease
Biomarkers of Cardiovascular Disease
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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 Progr...
Eligibility Criteria
Inclusion
- Eligible patients included those who had a diagnosis of coronary heart disease (CHD) from their physician or health plan, a diagnosis of diabetes, or at least 3 additional cardiac risk factors.
- A diagnosis of CHD included:
- having diagnosed CHD based on non-invasive testing such as exercise testing, nuclear imaging, echocardiogram or other test that clearly demonstrates ischemia
- cardiac catheterization demonstrating CHD
- eligibility for bypass surgery/PTCA and seeking a clinical alternative
- coronary bypass surgery
- PTCA/stent
- myocardial infarction.
- Type I or Type II diabetics were eligible for the program.
- For a participant to be included as a high-risk factor participant, the participant must have either a family history of premature CHD (1st-degree relative (male\<55; female \<65) with MI or sudden cardiac death) or be a male aged \> 45 or a female aged \> 55.
- In addition, there must be at least two additional cardiovascular risk factors, including:
- current cigarette smoking (within the past 5 years)
- hypertension: BP \> 140/90 mm Hg or on antihypertensive medication,
- low HDL-C: \<35 mg/dl or on medications for lipid therapy
- elevated apolipoprotein(a): \>30 mg/dl or on medications for elevated lipids
- high total cholesterol: \> 240 or on medications for elevated lipids
- high LDL-C: \>160 or on medications for elevated lipids
- high sensitivity C-Reactive Protein: \> 3 mg/dl and \< 10 mg/dl
- obesity: BMI \> 30
- Insulin Resistant State (Metabolic Syndrome X
Exclusion
- Exclusion criteria included:
- ischemic left main CHD, with an obstruction greater than 50%
- significant (\>70%) proximal left anterior descending artery disease and proximal left circumflex artery disease and an ejection fraction less than 50%, \*unstable angina
- hypotensive response to exercise (\> 20mm Hg drop in systolic BP)
- history of exercise induced ventricular tachycardia or 3rd degree heart block without evidence of current stability
- CABG surgery within 4 weeks, unless approved by medical director
- MI within one month, unless approved by medical director\\
- HF, with functional limitation and unresponsive to medications
- current tobacco user not concurrently enrolled in a smoking cessation program with 2-month history of smoking cessation
- uncontrolled malignant ventricular arrhythmia despite medications and/or implantable cardiac defibrillator (ICD), unless approved by medical director, resides beyond a one-hour commute to the Program site, unless approved by Team, \*history of substance abuse disorder (inc. ETOH) without documentation of a minimum one year of abstinence
- history of a significant psychiatric disorder without documentation of minimum one-year stability
- impaired cognitive function, such as dementia or delirium
- English language literacy unless Program site can accommodate
- non-ambulatory
- uncooperative spouse or life partner, defined as obstructive in attitude or behavior
- the patient is deemed to be potentially disruptive to group setting by the screening team.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT00820313
Start Date
October 1 2006
End Date
May 1 2009
Last Update
January 12 2009
Active Locations (1)
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1
Preventive Medicine Research Institute
Sausalito, California, United States, 94965