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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06356857
Acronym
Heart-Wave
Enrollment
20
Registered
2024-04-10
Start date
2024-04-15
Completion date
2026-03-17
Last updated
2025-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Blood Flow

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.

Interventions

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

Re-scan for comparison with initial scan

Sponsors

Peter Hovind
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
[O15]H2O-PET-MPI variability and repeatability coefficient estimated from 20 patients having [O15]H2O-PET-MPI done twice8 monthsIn 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026