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

P

Peter Hovind

Status

Not yet enrolling

Conditions

Myocardial Blood Flow

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT06356857
H-23070312

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Martin Krakauer, MD, Phd.; Laila Seidelin, MD, Phd.

Data sourced from clinicaltrials.gov

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