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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ischemic Heart Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in myocardial blood flow | The difference in assessed myocardial blood flow as measured by 15O-H2O PET and MR | 2 years | 
| Prognostic value within 10 years | Number of participants who experience a major adverse cardiac event within 10 years of follow-up. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in coronary flow reserve | The difference in assessed myocardial blood flow as measured by 15O-H2O PET and MR | 2 Years | 
| Difference in predictive value | The difference in predictive value of myocardial blood flow measurements as measured by 15O-H2O PET and MR | 10 years | 
| Difference in left ventricular end-systolic volume | The difference in left ventricular end-systolic volume as measured by 15O-H2O PET and MR | 2 years | 
| Difference in left ventricular end-diastolic volume | The difference in left ventricular end-diastolic volume as measured by 15O-H2O PET and MR | 2 years | 
| Difference in right ventricular end-systolic volume | The difference in right ventricular end-systolic volume as measured by 15O-H2O PET and MR | 2 years | 
| Difference in right ventricular end-diastolic volume | The difference in right ventricular end-diastolic volume as measured by 15O-H2O PET and MR | 2 years | 
| Difference in left ventricular mass | The difference in left ventricular mass as measured by 15O-H2O PET and MR | 2 years | 
| Amount of scar tissue | Scar tissue assessment as measured by MR | 2 years | 
| Pulmonary transit time | Pulmonary transit time as measured by 15O-H2O PET | 2 years | 
| Pulmonary perfusion | Pulmonary perfusion as measured by 15O-H2O PET | 2 years | 
| Prognostic value within 3,5 years | Number of participants who experience a major adverse cardiac event within 3,5 years of follow-up. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial perfusion imaging, Positron-Emission Tomography, Cardiac Magnetic Resonance Imaging, Coronary Artery Disease, Coronary Flow Reserve, Myocardial Blood Flow