Myocardial Perfusion Imaging by 15O-H2O PET/CT

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04451551

Enrollment

5000

Registered

2020-06-30

Start date

2020-06-23

Completion date

2036-08-01

Last updated

2024-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Heart Disease

Keywords

Myocardial Perfusion Imaging, Positron-Emission Tomography, Coronary Artery Disease, Coronary Flow Reserve, Myocardial Blood Flow, Prognosis, Reference Value

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Prognostic value within 10 years	10 years	Number of participants who experience a major adverse cardiac event within 10 years of follow-up.

Secondary

Measure	Time frame	Description
Coronary flow reserve	5 Years	The coronary flow reserve 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
Left ventricular end-diastolic volume	5 Years	The left ventricular end-diastolic volume 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
Right ventricular end-diastolic volume	5 Years	The right ventricular end-diastolic volume of participants assessed by 15O-H2O PET/CT
Myocardial blood flow	5 Years	The myocardial blood flow 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
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 5 years	5 years	Number of participants who experience a major adverse cardiac event within 5 years of follow-up.
Prognostic value within 2 years	2 years	Number of participants who experience a major adverse cardiac event within 2 years of follow-up.
Prognostic value within 1 years	1 years	Number of participants who experience a major adverse cardiac event within 1 years of follow-up.
Immediate coronary angiography followup	5 years	Number of participants who undergo coronary angiography within 3 months after primary 15O-H2O PET/CT

Countries

Denmark

Contacts

Primary ContactSimon Madsen, MD

simmas@rm.dk4520140596+

Outcome results