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Radioactive Agent
Myocardial Perfusion Imaging for Coronary Artery Disease
Phase < 1
Recruiting
Led By Pamela K Woodard, M.D
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up comparison to regional uptake on 13n-ammonia pet/ct performed 3-30 days after the 68ga-galmydar pet/ct
Awards & highlights
Study Summary
This trial will study how a type of medical imaging can help diagnose diseases in humans.
Who is the study for?
This trial is for men and women aged 18-99 with a history of heart issues, specifically those who've had certain types of heart scans showing possible blockages and are referred for further testing. It's not suitable for pregnant or breastfeeding women, individuals over 500 lbs, those with severe claustrophobia, uncontrolled high blood pressure, recent major heart procedures, chemotherapy within the last six months, serious lung diseases with wheezing, severe heart failure or conditions that prevent stress testing.Check my eligibility
What is being tested?
The study is evaluating [68Ga]Galmydar PET/CT imaging to see how well it can identify areas of the heart muscle that aren't getting enough blood flow in patients suspected to have coronary artery disease. This phase 0/1 trial will compare Galmydar images against traditional SPECT MPI results.See study design
What are the potential side effects?
Potential side effects may include reactions related to the PET/CT scan such as discomfort from lying still during the procedure. The tracers used (13N-ammonia and Ga-68 Galmydar) could cause allergic reactions or other side effects which will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had a heart scan showing reduced blood flow or a normal heart scan.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ comparison to regional mbf on 13n-ammonia pet/ct performed 3-30 days after the 68ga-galmydar pet/ct
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~comparison to regional mbf on 13n-ammonia pet/ct performed 3-30 days after the 68ga-galmydar pet/ct
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Semiquantitative assessment of 68Ga-Galmydar PET/CT uptake
Secondary outcome measures
Assessment of myocardial blood flow on 68Ga-Galmydar PET/CT
Change in heart rate.
Change in systolic or diastolic blood pressure.
+14 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: rest/ stress imaging day 2Experimental Treatment1 Intervention
On Imaging Day-2, participants will receive two single administrations each of 10 mCi of 13N-Ammonia during the rest and stress PET MPI.
Group II: Rest/ Stress imaging day 1Experimental Treatment1 Intervention
Participants will receive two [68Ga]Galmydar intravenous administrations, 4 mCi during rest and 8 mCi during stress for the PET MPI performed on Imaging Day-1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ga-68 Galmydar
2022
Completed Early Phase 1
~10
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,944 Previous Clinical Trials
2,304,463 Total Patients Enrolled
19 Trials studying Coronary Artery Disease
5,430 Patients Enrolled for Coronary Artery Disease
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,197 Total Patients Enrolled
10 Trials studying Coronary Artery Disease
11,861 Patients Enrolled for Coronary Artery Disease
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,847 Previous Clinical Trials
47,818,206 Total Patients Enrolled
165 Trials studying Coronary Artery Disease
269,002 Patients Enrolled for Coronary Artery Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a type of heart disease not caused by blocked arteries.I am between 18 and 99 years old.Your blood pressure is too low at the start of the trial (systolic blood pressure less than 90 mmHg, diastolic blood pressure less than 50 mmHg).I am unable to understand or sign the consent form.My blood pressure is not higher than 200/110 mmHg.I cannot have a stress test with Lexiscan.I've had a heart scan showing reduced blood flow or a normal heart scan.I have had heart artery surgery or a stent placed within the last 6 months.I have severe claustrophobia.I have a slow heartbeat or a block in my heart's electrical signals.I am not pregnant or breastfeeding.I have not had chemotherapy in the last 6 months.My heart's pumping ability is significantly reduced.I weigh less than 500 lbs.I have lung problems like COPD or asthma that cause wheezing and make certain treatments unsafe for me.
Research Study Groups:
This trial has the following groups:- Group 1: Rest/ Stress imaging day 1
- Group 2: rest/ stress imaging day 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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