Cardiovascular Risk Clinic

Study Overview
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Brief Summary
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This study was a prospective, randomized trial designed to investigate the efficacy of moderate lifestyle modification for improving the clinical status of patients with coronary artery disease or patients with risk factors that promote coronary artery disease.

Detailed Description
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The main hypothesis to be tested in the Cardiovascular Risk Clinic was: Can individualized therapeutic lifestyle plans in conjunction with molecular analysis lead to informative assessments of disease risk that can reduce risk factors for diabetes and cardiovascular disease. Our main objectives were: A. To investigate the effect of lifestyle modification on: (1) physiological measurements of coronary artery disease (CAD) including carotid intima-media thickness (CIMT), exercise stress tests, blood pressure, body mass index (BMI), and weight; (2) plasma markers associated with development of CAD such as lipids and triglycerides; and (3) molecular characteristics such as gene expression signatures and protein profiles. B. To determine if patients with heart disease or risk factors that would promote heart disease can achieve and adhere to the goals of a lifestyle change program in a non-residential, out-patient setting.

Official Title
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Cardiovascular Risk Clinic

Conditions
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Cardiovascular Disease, Coronary Artery Disease, Hypertension, Diabetes, Obesity

Intervention / Treatment
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* Behavioral: CRC lifestyle modification program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least one known risk factor for cardiovascular disease: Family history of CAD (first degree relative) Physician-diagnosed diabetes or stroke Overweight (BMI/=25) or obese (BMI>/=30) Total cholesterol >/=200, documented history of hypercholesterolemia, or currently taking lipid lowering medications History of smoking HDL </=44 mg/dl LDL >/=130 mg/dl or documented history of hyperlipidemia Elevated triglycerides (>/=200 mg/dl) Hypertension (systolic blood pressure >/=130 mmHg, diastolic blood pressure >/=85 mmHg, documented diagnosis of hypertension, or currently taking antihypertensive medications) Diabetes (fasting glucose >/=100 mg/dl, physician diagnosis of diabetes/pre-diabetes, or currently taking anti-glycemic medications) Post traumatic stress disorder (PTSD) or at risk for PTSD Insomnia (five hours of sleep per night or less) or sleep apnea Exclusion Criteria: Age <18 years of age Unstable coronary syndromes, refractory congestive heart failure, uncontrolled arrhythmia, or high-grade uncorrected cardiac conduction abnormalities Any contraindication to components to Program, such as physical disabilities precluding stretching and aerobic exercise or medical conditions that preclude consumption of foods essential to Program diet Inability or unwillingness to give consent Significant left main stenosis (>50%) or ejection fraction <35% with no revascularization History of substance abuse (including alcohol) without self-certification of abstinence for at least three months Non-ambulatory (bedridden) individuals

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle modification<br>The intervention group participated in individualized therapeutic lifestyle plans to reduce cardiovascular risk. Participants were introduced to factors contributing to cardiovascular disease and met individually with a registered dietitian, exercise physiologist, stress management instructor, and psychologist to learn effective strategies for integrating healthy changes into their current lifestyle. | Behavioral: CRC lifestyle modification program<br>* Intervention group enrolled in lifestyle program in which they developed individualized therapeutic lifestyle plans to reduce cardiovascular risk.<br>|
| No Intervention: Usual care controls<br>Control group received standard care from their primary physicians, but did not participate in any component of the lifestyle program or receive any information, advice, or counseling regarding healthy lifestyle behaviors. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index | Change in BMI | Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Change in systolic and diastolic BP | Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years | 
| Blood Lipids | Change in HDL, LDL, total cholesterol, and triglycerides | Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diet, lifestyle modification, exercise, cardiovascular disease, gene expression, obesity