Cardiovascular Risk Clinic

Obesity Clinical Trial

— CRC  

Official title:

Cardiovascular Risk Clinic

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02136758
• Other study ID #: 08-07
• Secondary ID: W81XWH-10-2-0080
• Status: Terminated
• Phase: N/A
• First received: May 8, 2014
• Last updated: May 8, 2014
• Start date: April 2009
• Est. completion date: July 2013

Study information

• Verified date: May 2014
• Source: Windber Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: US Army Medical Research and Materiel Command (MRMC)United States: Telemedicine and Advanced Technology Research Center (TATRC)United States: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 207
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Diabetes
• Hypertension
• Myocardial Ischemia
• Obesity

Intervention

Behavioral:
• CRC lifestyle modification program
Intervention group enrolled in lifestyle program in which they developed individualized therapeutic lifestyle plans to reduce cardiovascular risk.

Locations

Country	Name	City	State
United States	Windber Research Institute	Windber	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Windber Research Institute	Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exercise Capacity	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	No
Primary	Body Mass Index	Change in BMI	Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years	No
Secondary	Blood Pressure	Change in systolic and diastolic BP	Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years	No
Secondary	Blood Lipids	Change in HDL, LDL, total cholesterol, and triglycerides	Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years	No

External Links

•   Windber Research Institute