Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT02136758
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02136758
Study Brief:
Protocol Section:
NCT02136758