Myocardial Perfusion Imaging by Combined 15O-H2O PET and MR

Completed

• Conditions: Ischemic Heart Disease

• Registration Number: NCT04940247
• Lead Sponsor: University of Aarhus

Brief Summary

The trial will include 75 patients with evident or suspected ischemic heart disease refered to Department of Nuclear Medicine \& PET Centre, Aarhus University Hospital, for perfusion imaging by 15O-H2O PET/CT scan of the heart during rest and stress. Instead of the clinical scan participants will undergo perfusion imaging by 15O-H2O PET/MR.

The clinician will receive diagnostic information based on the 15O-H2O PET scan as if the patient had not participated in the study. As such, the study has no influence on the diagnostics or treatments of the patient.

Data from the scans will be used to compare 15O-H2O PET with cardiac MR for evaluation of myocardial perfusion.

Follow up will be done for up to 10 years in regards to major cardiovascular events in order to determine the prognostic value of the scan.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-08
• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-25
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-21
• Last Update Posted: 2022-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• Refered for myocardial perfusion imaging by O15-H2O PET at Department of Nuclear Medicine & PET Centre, Aarhus University Hospital
• > 18 years of age

Exclusion Criteria

• Allergic to adenosine
• Allergic to gadolinium
• Pregnancy
• Claustrophobia
• Severe Asthma
• Pacemaker or other ferro-magnetic implants
• GFR < 30

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prognostic value within 10 years	10 years	Number of participants who experience a major adverse cardiac event within 10 years of follow-up.
Difference in myocardial blood flow	2 years	The difference in assessed myocardial blood flow as measured by 15O-H2O PET and MR

Secondary Outcome Measures

Name	Time	Method
Difference in predictive value	10 years	The difference in predictive value of myocardial blood flow measurements as measured by 15O-H2O PET and MR
Difference in left ventricular mass	2 years	The difference in left ventricular mass as measured by 15O-H2O PET and MR
Pulmonary transit time	2 years	Pulmonary transit time as measured by 15O-H2O PET
Prognostic value within 3,5 years	5 years	Number of participants who experience a major adverse cardiac event within 3,5 years of follow-up.
Difference in coronary flow reserve	2 Years	The difference in assessed myocardial blood flow as measured by 15O-H2O PET and MR
Difference in right ventricular end-diastolic volume	2 years	The difference in right ventricular end-diastolic volume as measured by 15O-H2O PET and MR
Pulmonary perfusion	2 years	Pulmonary perfusion as measured by 15O-H2O PET
Difference in left ventricular end-systolic volume	2 years	The difference in left ventricular end-systolic volume as measured by 15O-H2O PET and MR
Difference in left ventricular end-diastolic volume	2 years	The difference in left ventricular end-diastolic volume as measured by 15O-H2O PET and MR
Difference in right ventricular end-systolic volume	2 years	The difference in right ventricular end-systolic volume as measured by 15O-H2O PET and MR
Amount of scar tissue	2 years	Scar tissue assessment as measured by MR

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Aarhus N, Denmark