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

NCT06356857 | Active Not Recruiting

• 1 other identifier: H-23070312
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Blood Flow

Outcome Measures

Primary Outcomes (1)

• [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

Study Arms (1)

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

Interventions

Myocardial perfusion imaging (MPI) using [O15]H2O-PET-CT DIAGNOSTIC_TEST

Re-scan for comparison with initial scan

re-pet participant

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peter Hovind: lead

Study Sites (1)

Bispebjerg Hospital

Copenhagen, RegionH, 2400, Denmark

Location

MeSH Terms

Interventions

Myocardial Perfusion Imaging

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Perfusion Imaging; Radionuclide Imaging; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques, Radioisotope

Study Officials

• Peter Hovind, MD, Phd.

  Bispebjerg hospital, capitol region Denmark

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of department, Department of Clinical Physiology and Nuclear Medicine and PET

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: April 10, 2024
• Study Start: April 15, 2024
• Primary Completion: March 17, 2025
• Study Completion: March 17, 2026
• Last Updated: April 6, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)