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

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 Overview

• Status: Active, not recruiting
• Conditions: Myocardial Blood Flow
• Intervention / Treatment: Diagnostic test: Myocardial perfusion imaging (MPI) using [O15]H2O-PET-CT

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• Denmark
  • RegionH
    • Copenhagen, RegionH, Denmark, 2400
      • Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
re-pet participant; Participant are enrolled for a second pet-scan which will be compared with the initial scan.	Diagnostic test: Myocardial perfusion imaging (MPI) using [O15]H2O-PET-CT; Re-scan for comparison with initial scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
[O15]H2O-PET-MPI variability and repeatability coefficient estimated from 20 patients having [O15]H2O-PET-MPI done twice	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.	8 months

Collaborators and Investigators

• Sponsor: Peter Hovind
• Investigators: Study Chair: Peter Hovind, MD, Phd., Bispebjerg hospital, capitol region Denmark

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Actual): March 17, 2025
• Study Completion (Estimated): March 17, 2026

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: H-23070312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No