Assessing Repeatability and Intra-individual Variability... | NCT06356857

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

NCT06356857

Sponsor

Peter Hovind

Status

Active, not recruiting

Last Update Posted

Apr 6, 2025Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Myocardial Blood Flow

Interventions

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

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2024Actual

Primary Completion Date

Mar 17, 2025Actual

Completion Date

Mar 17, 2026Estimated

First Submitted Date

Mar 13, 2024

First Submission Date that Met QC Criteria

Apr 4, 2024

First Posted Date

Apr 10, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2025

Last Update Posted Date

Apr 6, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Myocardial perfusion imaging (MPI) using [O15]H2O-PET-CT	Diagnostic Test	Re-scan for comparison with initial scan	re-pet participant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
[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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients > 50 years of age with symptoms suggestive of myocardial ischemia, primarily angina. They have therefore undergone [O15]H2O-PET-MPI by the dept. of cardiology on clinical indication.

The investigators will include 50% women.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Peter Hovind, MD, Phd.	Bispebjerg hospital, capitol region Denmark	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Bispebjerg Hospital		Copenhagen	RegionH	2400	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D055414	Myocardial Perfusion Imaging

Ancestor Terms

ID	Term
D057791	Cardiac Imaging Techniques
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

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Browse Branches

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