Myocardial Perfusion Imaging Galmydar Rest/Stress
A single center, phase 0/1 clinical imaging study designed to assess the role of \[68Ga\]Galmydar PET/CT imaging in human subjects.
Conditions:
🦠 Coronary Artery Disease
🗓️ Study Start (Actual) 11 November 2022
🗓️ Primary Completion (Estimated) 1 April 2025
✅ Study Completion (Estimated) 1 April 2025
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase EARLY_PHASE1
Locations:
📍 Saint Louis, Missouri, United States

📋 Eligibility Criteria

Description

    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)
Ages Eligible for Study: 18 Years to 99 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 13 November 2022
  • First Submitted that Met QC Criteria 20 November 2022
  • First Posted 23 November 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 25 April 2024
  • Last Update Posted 26 April 2024
  • Last Verified April 2024