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

Ischemic Heart Disease Clinical Trial

— PREFER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04940247
• Other study ID #: PREFER
• Status: Completed
• Start date: February 8, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: December 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in myocardial blood flow	The difference in assessed myocardial blood flow as measured by 15O-H2O PET and MR	2 years
Primary	Prognostic value within 10 years	Number of participants who experience a major adverse cardiac event within 10 years of follow-up.	10 years
Secondary	Difference in coronary flow reserve	The difference in assessed myocardial blood flow as measured by 15O-H2O PET and MR	2 Years
Secondary	Difference in predictive value	The difference in predictive value of myocardial blood flow measurements as measured by 15O-H2O PET and MR	10 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Difference in left ventricular mass	The difference in left ventricular mass as measured by 15O-H2O PET and MR	2 years
Secondary	Amount of scar tissue	Scar tissue assessment as measured by MR	2 years
Secondary	Pulmonary transit time	Pulmonary transit time as measured by 15O-H2O PET	2 years
Secondary	Pulmonary perfusion	Pulmonary perfusion as measured by 15O-H2O PET	2 years
Secondary	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