Clinical trial NCT02136758: Cardiovascular Risk Clinic
Official title: Cardiovascular Risk Clinic
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiovascular Disease
Coronary Artery Disease
Hypertension
Diabetes
Obesity
Keywords: lifestyle modification
diet
exercise
cardiovascular disease
gene expression
obesity
Lead sponsor: Windber Research Institute
Sponsor class: OTHER
Collaborators: name: Walter Reed National Military Medical Center
First posted: 2014-05-13
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Body Mass Index
timeFrame: Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years
Secondary outcomes:
measure: Blood Pressure
timeFrame: Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years
measure: Blood Lipids
timeFrame: Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years
Other outcomes:
measure: Exercise Capacity
timeFrame: Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years
Locations:
city: Windber
country: United States
facility: Windber Research Institute
state: Pennsylvania
Study officials:
affiliation: Windber Research Institute
name: Darrell L Ellsworth, PhD
role: PRINCIPAL_INVESTIGATOR
References: