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 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT04528758
Eligibility Criteria:
Inclusion Criteria:
* Male and female, 21-75 years of age and any race.
* Capable of giving written informed consent.
* "Healthy adult volunteer subject" is someone who is volunteering to undergo imaging procedures and based on screening procedures has no known significant health problems.
* Stable patients with known or suspected coronary artery disease that are scheduled to have or have undergone a clinically indicated conventional rest/stress SPECT MPI and no intervention between SPECT and PET.
* Female subjects must not be pregnant or lactating.
Exclusion Criteria:
* Has any condition that, in the opinion of the Sponsor-Investigator or designee could increase risk to the subject, limit the subject's ability to tolerate the research procedures, or interfere with collection of the data.
* Have abnormal findings on any screening/baseline procedure, e.g. physical examination, laboratory tests, electrocardiogram that suggest the subject might have a condition that could, in the opinion of the Sponsor-Investigator, affect the subject's response to the radiopharmaceutical or related research procedures.
* Is deemed likely to be unable to perform all research procedures for any reason, (e.g., subjects unable to lie still or inability to tolerate up to 60 minutes in a supine position with arms up during the PET imaging procedures due to chronic back/shoulder pain or arthritis as assessed by physical examination and medical history).
* Has a history of hypersensitivity to Fluorine-18 or other radiopharmaceutical or any of its excipients.
* Have contraindications to cardiovascular PET/CT imaging such as claustrophobia.
* Have high blood pressure (\>200/110)
* Have Epilepsy
* Have major kidney or liver problems
* Have current or past history of major medical illness
* Currently using recreational drugs
* Body weight of \> 300 lbs. (weight limit of the PET/CT table)
* Stable Cardiac Disease: Rest/Stress Group only:
* Cardiac patients who suffer an intervening clinical event such as worsening angina pectoris or myocardial infarction or whom undergo a myocardial revascularization procedure or have myocardial ischemia at rest.
* Sinus node disease (e.g. SA block) or symptomatic bradycardia, second or third degree atrioventricular (AV) block.
* Pre-existing obstructive lung disease (e.g. asthma) that precludes the safe administration of the pharmacological stressor according to the approved label.
* Uncontrolled and severe hypertension (e.g. systolic blood pressure \>200 mmHg, diastolic blood pressure \>110 mmHg).
* Baseline hypotension (e.g. systolic blood pressure \< 90 mmHg, diastolic blood pressure \<50 mmHg).
* Seizures
* The use of caffeine, nicotine or over the counter cold medicines within 12 hours prior to stress imaging day with regadenoson.
* The theophylline-based medications or dipyridamole within 48 hours prior to each imaging day.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT04528758
Study Brief:
Protocol Section:
NCT04528758