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

NCT ID: NCT06356857

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-15

Study Completion Date

2026-03-17

Brief Summary

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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

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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.

Conditions

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Myocardial Blood Flow

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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re-pet participant

Participant are enrolled for a second pet-scan which will be compared with the initial scan.

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

Intervention Type DIAGNOSTIC_TEST

Re-scan for comparison with initial scan

Interventions

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

Re-scan for comparison with initial scan

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peter Hovind

OTHER

Sponsor Role lead

Responsible Party

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Peter Hovind

Head of department, Department of Clinical Physiology and Nuclear Medicine and PET

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Peter Hovind, MD, Phd.

Role: STUDY_CHAIR

Bispebjerg hospital, capitol region Denmark

Locations

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Bispebjerg Hospital

Copenhagen, RegionH, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-23070312

Identifier Type: -

Identifier Source: org_study_id

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