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Recruiting
NCT05625490
Myocardial Perfusion Imaging Galmydar Rest/Stress
Conditions: Coronary Artery Disease
Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: 1
Phase: EARLY_PHASE1
Enrollment: 30
Sponsor: Washington University School of Medicine
Location: United States
Summary
A single center, phase 0/1 clinical imaging study designed to assess the role of [68Ga]Galmydar PET/CT imaging in human subjects.
Eligibility Criteria
Inclusion Criteria:Male and female, 18-99 years of age and any race;Have had a prior clinical SPECT MPI positive for ischemia in two myocardial segments and referred for invasive coronary angiography (ICA) or have had a prior clinical SPECT MPI negative for ischemia;Exclusion Criteria:Inability to receive and sign informed consent;Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 6-months prior to SPECT or in the intervening days between SPECT and PET examination;Participants who have received chemotherapeutic agents within 6 months of enrollment;Heart failure (left ventricular ejection fraction ≤ 35%);Known non-ischemic cardiomyopathy;Inability to undergo pharmacologic stress testing with regadenoson (Lexiscan).
Contraindications include:Symptomatic bradycardia or second to third degree atrioventricular (AV) block;Pre-existing obstructive lung disease with active wheezing, i.e., COPD, asthma with active wheezing that precludes the safe administration of the pharmacological stress agent 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);Women who are pregnant or breastfeeding;Severe claustrophobia;Weight ≥ 500 lbs (weight limit of PET/CT table)
Source: ClinicalTrials.gov (NCT05625490). StuddyBuddy aggregates publicly available trial information.