All > Coronary Artery Disease > Missouri

[O-15]-Water PET Myocardial Perfusion Imaging (MPI) for Coronary Artery Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Washington University, Saint Louis, MOCoronary Artery Disease[O-15]-Water PET Cardiac Perfusion Imaging - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new PET imaging method to help diagnose coronary artery disease (CAD) in 182 participants at 10 sites in the US & Europe. The participants will receive two doses of a special imaging agent and have safety follow-ups.

Eligible Conditions
  • Coronary Artery Disease

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Rest/ Stress imaging day 1
1
PET/CT imaging with [18F]CTT1057
3
Evolocumab Injections

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 30 days

30 days
Adverse event analyses will include tabulations of the incidence (number and percent of subjects) with at least one TEAEs overall and by MedDRA system organ class (SOC) and preferred term (PT). This will be repeated for serious adverse.
Incidence (number and percent of participants) of treatment-emergent adverse events (TEAEs) and procedure-related AEs by MedDRA system organ class (SOC) and preferred term (PT).
Sensitivity and specificity of [15-O]-H2O PET MPI in participants of special clinical interest (female, BMI≥30, diabetics, multivessel disease)
Sensitivity and specificity of the [15-O]-H2O PET study using the truth-standard of ICA with FFR or CCTA.
Sensitivity, specificity, and accuracy of [15-O]-H2O PET MPI in participants of special clinical interest (female, BMI≥30, diabetics, multivessel disease).

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Rest/ Stress imaging day 1
2
PET/CT imaging with [18F]CTT1057
3
Evolocumab Injections

Trial Design

2 Treatment Groups

[O-15]-Water PET Myocardial Perfusion Imaging (MPI)
1 of 2
[O-15]-Water PET Cardiac Perfusion Imaging
1 of 2

Experimental Treatment

215 Total Participants · 2 Treatment Groups

Primary Treatment: [O-15]-Water PET Myocardial Perfusion Imaging (MPI) · No Placebo Group · Phase 3

[O-15]-Water PET Myocardial Perfusion Imaging (MPI)
Drug
Experimental Group · 1 Intervention: [O-15]-Water PET Myocardial Perfusion Imaging (MPI) · Intervention Types: Drug
[O-15]-Water PET Cardiac Perfusion Imaging
Drug
Experimental Group · 1 Intervention: [O-15]-Water PET Cardiac Perfusion Imaging · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days

Who is running the clinical trial?

MedTrace Pharma A/SLead Sponsor
Emily Vandenbroucke, PhDStudy ChairMedTrace Pharma A/S
1 Previous Clinical Trials
38 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
38 Patients Enrolled for Coronary Artery Disease
Emily VandenbrouckeStudy ChairMedTrace Pharma A/S
Rune Wiik KristensenStudy ChairMedTrace Pharma A/S

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
If you are a male participant, you will need to use birth control until the end of the study.
References

Frequently Asked Questions

How many volunteers are being recruited for this research?

"Affirmative. The clinical trial's page on clinicaltrials.gov reveals that it is presently looking for participants, after first being posted in May 8th 2022 and last edited on March 14th 2023. This study needs to enroll 215 individuals across 3 different medical sites." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies left in this clinical research project?

"Affirmative. According to clinicaltrials.gov, this medical study is presently enrolling participants and was initially posted on May 8th 2022. It has been updated as recently as March 14th 2023 and requires 215 patients across 3 sites for completion." - Anonymous Online Contributor

Unverified Answer

Has the [O-15]-Water PET Myocardial Perfusion Imaging (MPI) been given clearance by the FDA?

"Our Power team gave [O-15]-Water PET Myocardial Perfusion Imaging (MPI) a safety rating of 3, as the existing evidence from Phase 3 clinical trials indicate it is both efficacious and safe." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top