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

NCT04940247 | Completed DMC

• 1 other identifier: PREFER
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Heart Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Difference in coronary flow reserve

  2 Years

• Difference in predictive value

  10 years

• Difference in left ventricular end-systolic volume

  2 years

• Difference in left ventricular end-diastolic volume

  2 years

• Difference in right ventricular end-systolic volume

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 25, 2021
• Study Start: February 8, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: December 23, 2022

Record last verified: 2022-12

Locations

DK (1)