Cardiovascular Risk Clinic

Not Applicable

Terminated

• Conditions: Cardiovascular Disease; Coronary Artery Disease; Hypertension; Diabetes; Obesity
• Interventions: Behavioral: CRC lifestyle modification program

• Registration Number: NCT02136758
• Lead Sponsor: Windber Research Institute

Brief Summary

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

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 Timeline

• Study Start: 2009-04
• Primary Completion: 2013-06
• Study Completion: 2013-07
• Status Verified: 2014-05
• Study First Submitted: 2014-05-08
• Study First Submitted QC: 2014-05-08
• Last Update Submitted: 2014-05-08
• Study First Posted: 2014-05-13
• Last Update Posted: 2014-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 207

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle modification	CRC lifestyle modification program	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.

Primary Outcome Measures

Name	Time	Method
Body Mass Index	Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years	Change in BMI

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Windber Research Institute; 🇺🇸 Windber, Pennsylvania, United States