Clinical trial NCT06356857: Assessing Repeatability and Intra-individual Variability in [O15]H2O-PET Myocardial Perfusion Imaging
Official title: Assessing Repeatability and Intra-individual Variability in [O15]H2O-PET Myocardial Perfusion Imaging
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Myocardial Blood Flow
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients \> 50 years of age with symptoms suggestive of myocardial ischemia, primarily angina. They have therefore undergone \[O15\]H2O-PET-MPI by the dept. of cardiology on clinical indication.

The investigators will include 50% women.

Brief summary: This study wish to assess the reproducibility of baseline and hyperemic myocardial blood flow as well as myocardial blood flow reserve measurements with \[O15\]H2O-PET-MPI.

Detailed description: Myocardial perfusion imaging (MPI) using \[O15\]H2O-PET-CT represents a validated technique for quantitatively assessing myocardial blood flow (MBF) and myocardial flow reserve (MFR).

With advancements in scanner and software technology, it is now possible to accurately quantify both global and regional MBF in clinical PET-MPI studies. Reduced stress MBF or MFR, as determined by \[O15\]H2O-PET-MPI, is a reliable indicator for detecting hemodynamically significant coronary artery stenosis. Additionally, MBF and MFR offer valuable prognostic insights into mortality and the risk of myocardial infarction. Clinical experience suggests that implementing \[O15\]H2O-PET-MPI for coronary artery disease evaluation is not only feasible but also aids in making informed decisions regarding revascularization.

This study wish to assess the reproducibility of baseline and hyperemic myocardial blood flow as well as myocardial blood flow reserve measurements with \[O15\]H2O-PET-MPI.

Eligibility criteria: Inclusion Criteria:

* Patients \> 50 years of age referred for \[O15\]H2O-PET-MPI by the dept. of cardiology on clinical indication with symptoms suggestive of myocardial ischemia, primarily angina.
* Willing to repeat the \[O15\]H2O-PET-MPI
* Normal left ventricular ejection fraction (EF \> 45), as assessed from recent (max 1 year old) echocardiography description in medical journal.

Exclusion Criteria:

* Cardiovascular event in between scans (defined as hospitalization for cardiovascular event).
* History of myocardial infarction
* Regional perfusion deficits on the primary \[O15\]H2O-PET-MPI clinically suspected as a sign of significant coronary stenosis.
* Unstable angina
* Severe Chronic Obstructive Pulmonary Disease (COPD)
* Severe asthma
* Claustrophobia
* Acute illness
* Significant language barrier, estimated by the investigator not being able to understand the study information sufficiently.

Primary outcomes:
measure: [O15]H2O-PET-MPI variability and repeatability coefficient estimated from 20 patients having [O15]H2O-PET-MPI done twice
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: RegionH
Study officials:
affiliation: Bispebjerg hospital, capitol region Denmark
name: Peter Hovind, MD, Phd.
role: STUDY_CHAIR
References: