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:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 1:02 AM
NCT ID:
NCT05286593
Eligibility Criteria:
Inclusion Criteria:
Normal Volunteers
* Adults ≥18 and \<40 years old able to give informed consent.
* Ability to abstain from caffeine for 48 hours
The "clinical" population
* Adults ≥18 years old able to give informed consent.
* Any cardiac risk factor including hypertension, hyperlipidemia, diabetes mellitus or tobacco use OR
* CAD defined by with history of PCI or CABG, Coronary Ca score\>400, or dense coronary calcifications noted on chest CT
* Ability to abstain from caffeine for 48 hours
The "infarct" population
* Adults ≥18 years old able to give informed consent.
* Prior cardiac PET scan demonstrating a fixed defect ≥ 15% of the LV myocardium with relative uptake ≤60% maximum uptake.
* In addition, to the perfusion defect, each volunteer requires either:
* FDG PET or MRI viability studies confirming infarct OR
* akinesis and wall thinning on ECHO within the same territory as the PET defect in addition to Q-waves on ECG
* Ability to abstain from caffeine for 48 hours
Exclusion Criteria:
Normal Volunteers
* Any chronic cardiac disease or condition (e.g., hypertension, hyperlipidemia)
* Any chronic systemic disease or condition (e.g., diabetes, systemic lupus, rheumatoid arthritis)
* Tobacco use
* Family history in a first degree relative with clinical CAD (h/o PCI, MI or CABG) in men \<55 or women \<65
* Severe claustrophobia
* Positive urine pregnancy test
* Inability to give informed consent
* BMI ≥ 30 or BMI\>25 and \<30 provided waist to hip ratio \>0.80 in women or 0.90 in men.
The "clinical" and "infarct" populations
* Severe claustrophobia
* Hemodynamic instability or unstable symptoms
* Positive urine pregnancy test
* Inability to give informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05286593
Study Brief:
Protocol Section:
NCT05286593