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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
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
Timeline
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
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 below
Select...
I am between 18 and 99 years old.
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I've had a heart scan showing reduced blood flow or a normal heart scan.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and comparison to regional uptake on 13n-ammonia pet/ct performed 3-30 days after the 68ga-galmydar pet/ct for reporting.

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 more

Trial 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
1,928 Previous Clinical Trials
2,296,934 Total Patients Enrolled
19 Trials studying Coronary Artery Disease
5,430 Patients Enrolled for Coronary Artery Disease
National Institutes of Health (NIH)NIH
2,682 Previous Clinical Trials
6,930,768 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
3,818 Previous Clinical Trials
47,295,267 Total Patients Enrolled
165 Trials studying Coronary Artery Disease
269,002 Patients Enrolled for Coronary Artery Disease

Media Library

13N-ammonia (Radioactive Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05625490 — Phase < 1
Coronary Artery Disease Research Study Groups: Rest/ Stress imaging day 1, rest/ stress imaging day 2
Coronary Artery Disease Clinical Trial 2023: 13N-ammonia Highlights & Side Effects. Trial Name: NCT05625490 — Phase < 1
13N-ammonia (Radioactive Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05625490 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently recruiting participants for this investigation?

"Affirmative. Clinicaltrials.gov shows that this clinical trial, which was posted on November 11th 2022 and recently updated on the 20th of the same month, is actively searching for participants to enroll in their study. 30 patients are required from 1 site."

Answered by AI

What is the scope of individuals participating in this experiment?

"Correct. According to the information found on clinicaltrials.gov, this study is currently recruiting candidates. The project was posted on November 11th 2022 and updated most recently on November 20th 2022. This trial necessitates 30 patients from one single medical centre for participation."

Answered by AI

Does this trial encompass individuals aged 25 or older?

"Individuals aged between 18 and 99 are eligible for enrolment in this clinical trial."

Answered by AI

What are the requirements for someone to be eligible to participate in this research study?

"This research is looking to enrol 30 participants aged 18-99, all genders and races included, who are diagnosed with coronary artery disease. Additional inclusion criteria include: a prior SPECT MPI report showing myocardial ischemia in two segments or lack thereof; being referred for an invasive cardiac angiography (ICA)."

Answered by AI
~0 spots leftby Apr 2024