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Cardiovascular Risk Clinic (CRC)

Primary Purpose

Cardiovascular Disease, Coronary Artery Disease, Hypertension

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CRC lifestyle modification program
Sponsored by
Windber Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Disease focused on measuring lifestyle modification, diet, exercise, cardiovascular disease, gene expression, obesity

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Windber Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lifestyle modification

Usual care controls

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Body Mass Index
Change in BMI

Secondary Outcome Measures

Blood Pressure
Change in systolic and diastolic BP
Blood Lipids
Change in HDL, LDL, total cholesterol, and triglycerides

Full Information

First Posted
May 8, 2014
Last Updated
May 8, 2014
Sponsor
Windber Research Institute
Collaborators
Walter Reed National Military Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02136758
Brief Title
Cardiovascular Risk Clinic
Acronym
CRC
Official Title
Cardiovascular Risk Clinic
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Funding cut due to government sequestration
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Windber Research Institute
Collaborators
Walter Reed National Military Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Coronary Artery Disease, Hypertension, Diabetes, Obesity
Keywords
lifestyle modification, diet, exercise, cardiovascular disease, gene expression, obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle modification
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care controls
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CRC lifestyle modification program
Intervention Description
Intervention group enrolled in lifestyle program in which they developed individualized therapeutic lifestyle plans to reduce cardiovascular risk.
Primary Outcome Measure Information:
Title
Body Mass Index
Description
Change in BMI
Time Frame
Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
Change in systolic and diastolic BP
Time Frame
Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years
Title
Blood Lipids
Description
Change in HDL, LDL, total cholesterol, and triglycerides
Time Frame
Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years
Other Pre-specified Outcome Measures:
Title
Exercise Capacity
Description
Change in exercise capacity defined by Bruce score on an exercise treadmill test
Time Frame
Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darrell L Ellsworth, PhD
Organizational Affiliation
Windber Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Windber Research Institute
City
Windber
State/Province
Pennsylvania
ZIP/Postal Code
15963
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.wriwindber.org
Description
Windber Research Institute

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Cardiovascular Risk Clinic

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