Myocardial Perfusion Imaging by 15O-H2O PET/CT

Recruiting

• Conditions: Ischemic Heart Disease

• Registration Number: NCT04451551
• Lead Sponsor: University of Aarhus

Brief Summary

The trial will include 5000 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. The patients will undergo the clinical scan as normal.

Data from the scans will be used to determine reference values of the examination.

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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2020-06-23
• Study First Submitted: 2020-06-23
• Study First Submitted QC: 2020-06-26
• Study First Posted: 2020-06-30
• Status Verified: 2023-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-24
• Primary Completion: 2026-08-01
• Study Completion: 2036-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Known or suspected ischemic heart disease referred for a clinical H2O-PET at Department of Nuclear Medicine and PET Centre, Aarhus University Hospital

Read More

Exclusion Criteria

• Claustrophobia, severe asthma, younger than 18 years

Read More

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.

Secondary Outcome Measures

Name	Time	Method
Prognostic value within 2 years	2 years	Number of participants who experience a major adverse cardiac event within 2 years of follow-up.
Myocardial blood flow	5 Years	The myocardial blood flow of participants assessed by 15O-H2O PET/CT
Coronary flow reserve	5 Years	The coronary flow reserve of participants assessed by 15O-H2O PET/CT
Right ventricular end-systolic volume	5 Years	The right ventricular end-systolic volume of participants assessed by 15O-H2O PET/CT
Pulmonary transit time	5 Years	The pulmonary transit time of participants assessed by 15O-H2O PET/CT
Left ventricular end-systolic volume	5 Years	The left ventricular end-systolic volume of participants assessed by 15O-H2O PET/CT
Right ventricular end-diastolic volume	5 Years	The right ventricular end-diastolic volume of participants assessed by 15O-H2O PET/CT
Immediate percutaneous coronary intervention (PCI) followup	5 years	Number of participants who undergo percutaneous coronary intervention within 3 months after primary 15O-H2O PET/CT
Prognostic value within 5 years	5 years	Number of participants who experience a major adverse cardiac event within 5 years of follow-up.
Left ventricular end-diastolic volume	5 Years	The left ventricular end-diastolic volume of participants assessed by 15O-H2O PET/CT
Immediate coronary angiography followup	5 years	Number of participants who undergo coronary angiography within 3 months after primary 15O-H2O PET/CT
Immediate coronary artery bypass graft (CABG) followup	5 years	Number of participants who undergo coronary artery bypass graft within 3 months after primary 15O-H2O PET/CT
Prognostic value within 1 years	1 years	Number of participants who experience a major adverse cardiac event within 1 years of follow-up.

Trial Locations

Locations (1)

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