Cardiovascular Risk Clinic

Windber Research Institute207 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

207

Conditions

Cardiovascular Disease Coronary Artery Disease Hypertension Diabetes Obesity

Interventions

CRC lifestyle modification programBEHAVIORAL

Intervention group enrolled in lifestyle program in which they developed individualized therapeutic lifestyle plans to reduce cardiovascular risk.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Windber Research Institute

Windber, Pennsylvania, United States

Outcomes

Primary Outcomes

Body Mass Index

Change in BMI

Time frame: Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years

Secondary Outcomes

Blood Pressure

Change in systolic and diastolic BP

Time frame: Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years

Blood Lipids

Change in HDL, LDL, total cholesterol, and triglycerides

Time frame: Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years

Data from ClinicalTrials.gov

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