Clinical trial NCT04940247: Myocardial Perfusion Imaging by Combined 15O-H2O PET and MR
Official title: Myocardial Perfusion Imaging by Combined 15O-H2O PET and MR for Evaluation of Reversible Myocardial Ischemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Heart Disease
Keywords: Myocardial perfusion imaging
Positron-Emission Tomography
Cardiac Magnetic Resonance Imaging
Coronary Artery Disease
Coronary Flow Reserve
Myocardial Blood Flow
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient with known or suspected ischemic heart disease referred for a clinical H2O-PET at Department of Nuclear Medicine and PET Centre, Aarhus University Hospital, not meeting any exclusion criteria will be enrolled in the study.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in myocardial blood flow
timeFrame: 2 years
measure: Prognostic value within 10 years
timeFrame: 10 years
Secondary outcomes:
measure: Difference in coronary flow reserve
timeFrame: 2 Years
measure: Difference in predictive value
timeFrame: 10 years
measure: Difference in left ventricular end-systolic volume
timeFrame: 2 years
measure: Difference in left ventricular end-diastolic volume
timeFrame: 2 years
measure: Difference in right ventricular end-systolic volume
timeFrame: 2 years
measure: Difference in right ventricular end-diastolic volume
timeFrame: 2 years
measure: Difference in left ventricular mass
timeFrame: 2 years
measure: Amount of scar tissue
timeFrame: 2 years
measure: Pulmonary transit time
timeFrame: 2 years
measure: Pulmonary perfusion
timeFrame: 2 years
measure: Prognostic value within 3,5 years
timeFrame: 5 years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Aarhus N
Study officials:
References: