Myocardial Perfusion Imaging by 15O-H2O PET/CT

Ischemic Heart Disease Clinical Trial

Official title:

Myocardial Perfusion Imaging by 15O-H2O PET/CT: Reference Values and Prognostic Value

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04451551
• Other study ID #: 15O-H2O PET Cohort
• Status: Recruiting
• Start date: June 23, 2020
• Est. completion date: August 1, 2036

Study information

• Verified date: January 2023
• Source: University of Aarhus
• Contact: Simon Madsen, MD
• Phone: 4520140596+
• Email: simmas[@]rm.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: August 1, 2036
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• Claustrophobia, severe asthma, younger than 18 years

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognostic value within 10 years	Number of participants who experience a major adverse cardiac event within 10 years of follow-up.	10 years
Secondary	Myocardial blood flow	The myocardial blood flow of participants assessed by 15O-H2O PET/CT	5 Years
Secondary	Coronary flow reserve	The coronary flow reserve of participants assessed by 15O-H2O PET/CT	5 Years
Secondary	Pulmonary transit time	The pulmonary transit time of participants assessed by 15O-H2O PET/CT	5 Years
Secondary	Left ventricular end-systolic volume	The left ventricular end-systolic volume of participants assessed by 15O-H2O PET/CT	5 Years
Secondary	Left ventricular end-diastolic volume	The left ventricular end-diastolic volume of participants assessed by 15O-H2O PET/CT	5 Years
Secondary	Right ventricular end-systolic volume	The right ventricular end-systolic volume of participants assessed by 15O-H2O PET/CT	5 Years
Secondary	Right ventricular end-diastolic volume	The right ventricular end-diastolic volume of participants assessed by 15O-H2O PET/CT	5 Years
Secondary	Immediate coronary angiography followup	Number of participants who undergo coronary angiography within 3 months after primary 15O-H2O PET/CT	5 years
Secondary	Immediate percutaneous coronary intervention (PCI) followup	Number of participants who undergo percutaneous coronary intervention within 3 months after primary 15O-H2O PET/CT	5 years
Secondary	Immediate coronary artery bypass graft (CABG) followup	Number of participants who undergo coronary artery bypass graft within 3 months after primary 15O-H2O PET/CT	5 years
Secondary	Prognostic value within 5 years	Number of participants who experience a major adverse cardiac event within 5 years of follow-up.	5 years
Secondary	Prognostic value within 2 years	Number of participants who experience a major adverse cardiac event within 2 years of follow-up.	2 years
Secondary	Prognostic value within 1 years	Number of participants who experience a major adverse cardiac event within 1 years of follow-up.	1 years