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 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT01109992
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years
* Clinically indicated N-13 ammonia PET study or ten healthy volunteers
* Known coronary artery disease (prior percutaneous coronary intervention, prior coronary artery bypass surgery or Q wave MI on ECG) or intermediate to high pretest likelihood of CAD
* Able to exercise on a treadmill
* Able and willing to provide informed consent to participate in the study
Exclusion Criteria:
* Contraindications to exercise stress testing such as, unstable angina, known severe left main coronary artery stenosis, severe heart failure, uncontrolled arrhythmias, symptomatic hypotension or severe hypertension (systolic blood pressure \< 90 or \> 200 mmHg, respectively), or \> 1st degree atrioventricular block in the absence of a functioning pacemaker.
* Subject requires emergent cardiac medical intervention or catheterization after the clinical study.
* Documented myocardial infarction (MI) ≤ 30 days prior to enrollment.
* History of percutaneous coronary intervention (PCI) ≤ 4weeks prior to enrollment.
* History of coronary artery bypass graft (CABG) ≤ 8 weeks prior to enrollment.
* History of heart transplantation.
* Allergy or intolerance to aminophylline or regadenoson
* Known severe or oxygen dependent bronchoconstrictive or bronchospastic lung disease \[e.g., asthma, wheezing, chronic obstructive pulmonary disease (COPD), etc.\].
* Severe LV dysfunction, with ejection fraction of \< 30%
* Serious non-cardiac medical illness (e.g., disseminated malignancy, severe neurological dysfunction at time of baseline PET study) or a social situation which will preclude research study participation
* History of Seizures.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01109992
Study Brief:
Protocol Section:
NCT01109992