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NCT Number: NCT06356857

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bispebjerg Hospital

Copenhagen, RegionH, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Diagnostic Test

Re-scan for comparison with initial scan

Primary outcomes

  1. [O15]H2O-PET-MPI variability and repeatability coefficient estimated from 20 patients having [O15]H2O-PET-MPI done twice

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peter Hovind

Other

Registry information

Acronym: Heart-Wave

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 10, 2024
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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