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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT06471569
Eligibility Criteria:
Inclusion Criteria:
* Individuals who completed participation in the STRRIDE-PD trial (NCT00962962)
* Body Mass Index (BMI) \> 18 and \< 45 kg/m2
* Stable dose (≥1 month) of any cardiometabolic medications
Exclusion Criteria:
* Poor vein access
* Current use of tobacco or any nicotine products, including e-cigarettes
* Insulin-dependent diabetes
* Active untreated hypothyroidism with thyroid stimulating hormone (TSH) concentrations \> 10.0 uIU/mL
* Systemic inflammatory or connective tissue disease, chronic infectious disease, chronic pulmonary disease or symptomatic cardiovascular disease with positive functional study by ECG or imaging
* Current, actively treated malignancy other than dermatologic conditions
* Absolute contraindications to exercise testing: ongoing unstable angina; uncontrolled cardiac arrhythmia with hemodynamic compromise; active endocarditis; symptomatic severe aortic stenosis; decompensated heart failure; acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis; acute myocarditis or pericarditis; acute aortic dissection; physical disability that precludes safe and adequate testing
* Relative contraindications to exercise testing: known obstructive left main coronary artery stenosis; moderate to severe aortic stenosis with uncertain relation to symptoms; tachyarrhythmias with uncontrolled ventricular rates; acquired advanced or complete heart block; hypertrophic obstructive cardiomyopathy with severe resting gradient; recent stroke or transient ischemic attack; mental impairment with limited ability to cooperate; uncorrected medical conditions, such as hypertension, significant anemia, important electrolyte imbalance, and hyperthyroidism
* Modified testing contraindications: acute myocardial infarction (MI) within six months; resting hypertension with systolic or diastolic blood pressures \>160/90 mmHg
* Unable to safely participate in an exercise program per study protocol per PI discretion
* Planned, intentional weight loss during study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
90 Years
Study:
NCT06471569
Study Brief:
Protocol Section:
NCT06471569