Assessing Repeatability and Intra-individual Variability in [O15]H2O-PET Myocardial Perfusion Imaging

Active, not recruiting

• Conditions: Myocardial Blood Flow
• Interventions: Diagnostic Test: Myocardial perfusion imaging (MPI) using [O15]H2O-PET-CT

• Registration Number: NCT06356857
• Lead Sponsor: Peter Hovind

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.

Study Timeline

• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-04-04
• Study First Posted: 2024-04-10
• Study Start: 2024-04-15
• Status Verified: 2024-08
• Primary Completion: 2025-03-17
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Study Completion: 2026-03-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
re-pet participant	Myocardial perfusion imaging (MPI) using [O15]H2O-PET-CT	Participant are enrolled for a second pet-scan which will be compared with the initial scan.

Primary Outcome Measures

Name	Time	Method
[O15]H2O-PET-MPI variability and repeatability coefficient estimated from 20 patients having [O15]H2O-PET-MPI done twice	8 months	In this study two \[O15\]H2O-PET-CT scans in the same induvidual at two different timepoints will be conducted. This will allow a variability estimation (for each meassurement eg rest MBF (ml/g/min), stress MBF (ml/g/min)) and thereby a calculated repeatability coefficient.

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, RegionH, Denmark