PET-MR Imaging of Coronary Atherothrombosis

University of Edinburgh

Status: Completed

Conditions: Heart Diseases, Ischemic

Treatments: Diagnostic Test: PET-MRI scan

Study type: Interventional

Funder types: Other

Identifiers

NCT03618303

AC17091

Details and patient eligibility

About

Heart attacks remain a common cause of death throughout the world. The most common initiating event is the formation of a blood clot within the coronary arteries occluding blood supply to the heart. However, we know that thrombus often occurs within the coronary arteries without causing any symptoms, and may be found in patients with stable angina. We wish to investigate whether blood clots within the coronary arteries can be detected in patients who have had a heart attack and in patients with stable angina using combined positron emission tomography and magnetic resonance (PET-MR) imaging. If possible, this may provide a safe and noninvasive means of identifying patients at higher risk of heart attacks.

The study will be conducted in Edinburgh Heart Centre and a total of 40 participants will be recruited from the cardiology wards, outpatient clinics and day case unit. Participants will be asked to undergo a single PET-MRI scan in addition to invasive angiography as part of standard care (non-research procedure). During the invasive angiogram procedure, an additional imaging test may be performed called Optical Coherence Tomography to provide images from within the heart blood vessels.

Enrollment: 9 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previously diagnosed coronary artery disease undergoing elective invasive angiography OR
• Admitted with acute coronary syndrome diagnosed by two of the following criteria 1) Elevation of cardiac biomarkers (High sensitivity cardiac troponin I greater than 34 ng/l in men and 16ng/l in women) 2) Symptoms of myocardial ischaemia 3) ECG changes indicative of acute ischaemia

Exclusion criteria

• Contraindication or inability to undergo MRI scanning
• Renal failure (estimated glomerular filtration rate less than 30mL/min
• Undergoing Primary PCI
• Ongoing myocardial ischaemia or dynamic ECG changes
• Inability to provide informed consent
• Known allergy to gadolinium based contrast
• Women who are pregnant, breastfeeding or of child-bearing potential

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Interventional

Experimental group

Description:

All patients will undergo the same intervention of having a PET-MRI scan and optical coherence tomography.

Treatment:

Diagnostic Test: PET-MRI scan