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CompletedNCT04940247PREFERUpdated Dec 23, 2022

Myocardial Perfusion Imaging by Combined 15O-H2O PET and MR

An observational study in Ischemic Heart Disease, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-23.

Sponsored by University of Aarhus · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
73
Ages
18 Years and older
Sex
All
01

Study summary

The trial will include 75 patients with evident or suspected ischemic heart disease refered to Department of Nuclear Medicine \& PET Centre, Aarhus University Hospital, for perfusion imaging by 15O-H2O PET/CT scan of the heart during rest and stress. Instead of the clinical scan participants will undergo perfusion imaging by 15O-H2O PET/MR.

The clinician will receive diagnostic information based on the 15O-H2O PET scan as if the patient had not participated in the study. As such, the study has no influence on the diagnostics or treatments of the patient.

Data from the scans will be used to compare 15O-H2O PET with cardiac MR for evaluation of myocardial perfusion.

Follow up will be done for up to 10 years in regards to major cardiovascular events in order to determine the prognostic value of the scan.

02

Conditions studied

  • Ischemic Heart Disease

Keywords

  • Myocardial perfusion imaging
  • Positron-Emission Tomography
  • Cardiac Magnetic Resonance Imaging
  • Coronary Artery Disease
  • Coronary Flow Reserve
  • Myocardial Blood Flow
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 73 is below the median of 294 across 1,241 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Any patient with known or suspected ischemic heart disease referred for a clinical H2O-PET at Department of Nuclear Medicine and PET Centre, Aarhus University Hospital, not meeting any exclusion criteria will be enrolled in the study.

Inclusion criteria

  • Refered for myocardial perfusion imaging by O15-H2O PET at Department of Nuclear Medicine \& PET Centre, Aarhus University Hospital
  • > 18 years of age

Exclusion criteria

Exclusion Criteria:

  • Allergic to adenosine
  • Allergic to gadolinium
  • Pregnancy
  • Claustrophobia
  • Severe Asthma
  • Pacemaker or other ferro-magnetic implants
  • GFR \< 30
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
73 participants (actual)
Target follow-up
10 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Difference in myocardial blood flow

    The difference in assessed myocardial blood flow as measured by 15O-H2O PET and MR

    Time frame: 2 years

  2. Prognostic value within 10 years

    Number of participants who experience a major adverse cardiac event within 10 years of follow-up.

    Time frame: 10 years

Secondary outcomes

  1. Difference in coronary flow reserve

    The difference in assessed myocardial blood flow as measured by 15O-H2O PET and MR

    Time frame: 2 Years

  2. Difference in predictive value

    The difference in predictive value of myocardial blood flow measurements as measured by 15O-H2O PET and MR

    Time frame: 10 years

  3. Difference in left ventricular end-systolic volume

    The difference in left ventricular end-systolic volume as measured by 15O-H2O PET and MR

    Time frame: 2 years

  4. Difference in left ventricular end-diastolic volume

    The difference in left ventricular end-diastolic volume as measured by 15O-H2O PET and MR

    Time frame: 2 years

  5. Difference in right ventricular end-systolic volume

    The difference in right ventricular end-systolic volume as measured by 15O-H2O PET and MR

    Time frame: 2 years

  6. Difference in right ventricular end-diastolic volume

    The difference in right ventricular end-diastolic volume as measured by 15O-H2O PET and MR

    Time frame: 2 years

  7. Difference in left ventricular mass

    The difference in left ventricular mass as measured by 15O-H2O PET and MR

    Time frame: 2 years

  8. Amount of scar tissue

    Scar tissue assessment as measured by MR

    Time frame: 2 years

  9. Pulmonary transit time

    Pulmonary transit time as measured by 15O-H2O PET

    Time frame: 2 years

  10. Pulmonary perfusion

    Pulmonary perfusion as measured by 15O-H2O PET

    Time frame: 2 years

  11. Prognostic value within 3,5 years

    Number of participants who experience a major adverse cardiac event within 3,5 years of follow-up.

    Time frame: 5 years

07

Study locations

1 site
  • Aarhus University Hospital
    Aarhus, Aarhus N 8200, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04940247
Lead sponsor
University of Aarhus
Responsible party
Sponsor
First posted
Jun 25, 2021
Start date
Feb 8, 2021
Primary completion
Nov 1, 2022
Completion
Nov 1, 2022
Last update
Dec 23, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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