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

Myocardial Blood Flow Clinical Trial

— Heart-Wave  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06356857
• Other study ID #: H-23070312
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: Bispebjerg Hospital
• Contact: Laila Seidelin, MD, Phd.
• Phone: 004520353008
• Email: LSEI0019[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myocardial Blood Flow

Intervention

Diagnostic Test:
• Myocardial perfusion imaging (MPI) using [O15]H2O-PET-CT
Re-scan for comparison with initial scan

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen	RegionH

Sponsors (1)

Lead Sponsor	Collaborator
Peter Hovind

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[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