Cardiovascular Risk Clinic
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 207
- 试验地点
- 2
- 主要终点
- Body Mass Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Body Mass Index
时间窗: Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years
Change in BMI
次要结局
- Blood Pressure(Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years)
- Blood Lipids(Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years)