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Completed

NCT Number: NCT04940247

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

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.

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Key information

Conditions

Ischemic Heart Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital

Aarhus, Aarhus N, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

  1. Difference in myocardial blood flow

    Time frame: 2 years

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

  2. Prognostic value within 10 years

    Time frame: 10 years

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

Secondary outcomes

  1. Difference in coronary flow reserve

    Time frame: 2 Years

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

  2. Difference in predictive value

    Time frame: 10 years

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

  3. Difference in left ventricular end-systolic volume

    Time frame: 2 years

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

  4. Difference in left ventricular end-diastolic volume

    Time frame: 2 years

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

  5. Difference in right ventricular end-systolic volume

    Time frame: 2 years

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

  6. Difference in right ventricular end-diastolic volume

    Time frame: 2 years

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

  7. Difference in left ventricular mass

    Time frame: 2 years

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

  8. Amount of scar tissue

    Time frame: 2 years

    Scar tissue assessment as measured by MR

  9. Pulmonary transit time

    Time frame: 2 years

    Pulmonary transit time as measured by 15O-H2O PET

  10. Pulmonary perfusion

    Time frame: 2 years

    Pulmonary perfusion as measured by 15O-H2O PET

  11. Prognostic value within 3,5 years

    Time frame: 5 years

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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Myocardial Perfusion Imaging by Combined 15O-H2O PET and MR for Evaluation of Reversible Myocardial Ischemia

Acronym: PREFER

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 25, 2021
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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