Cardiovascular Risk Clinic (CRC)

May 8, 2014 updated by: Windber Research Institute
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

207

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Windber, Pennsylvania, United States, 15963
        • Windber Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lifestyle modification
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
Intervention group enrolled in lifestyle program in which they developed individualized therapeutic lifestyle plans to reduce cardiovascular risk.
NO_INTERVENTION: Usual care controls
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?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Capacity
Time Frame: Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years
Change in exercise capacity defined by Bruce score on an exercise treadmill test
Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Windber Research Institute

Collaborators

Walter Reed National Military Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

May 8, 2014

First Submitted That Met QC Criteria

May 8, 2014

First Posted (ESTIMATE)

May 13, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

May 13, 2014

Last Update Submitted That Met QC Criteria

May 8, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-07
  • W81XWH-10-2-0080 (OTHER_GRANT: US Department of Defense)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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