PET-MR Imaging of Coronary Atherothrombosis

Not Applicable

Completed

• Conditions: Heart Diseases, Ischemic
• Interventions: Diagnostic Test: PET-MRI scan

• Registration Number: NCT03618303
• Lead Sponsor: University of Edinburgh

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-16
• Study First Submitted: 2018-07-31
• Study First Submitted QC: 2018-07-31
• Study First Posted: 2018-08-07
• Primary Completion: 2020-03-24
• Study Completion: 2020-03-24
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Plaque-to-myocardial ratio of culprit plaques on T1-weighted imaging	Baseline	The identification of high risk plaques on T1-weighted MRI to determine whether coronary atherothrombosis can accurately be detected using non-invasive PET-MR imaging.

Secondary Outcome Measures

Name	Time	Method
The correlation between high risk plaques on PET-MR and culprit plaques on invasive angiography in patients with coronary artery disease.	Baseline	The relationship between positive plaques identified on PET-MR by both T1-weighted MRI and 18F-NaF PET and culprit plaques on invasive angiography
The correlation between coronary plaque thrombosis (MRI), high-risk plaque (PET) and the presence of myocardial infarction on MRI (late enhancement).	Baseline	The relationship between high risk plaque features on MRI and PET with evidence of myocardial infarction on MRI.

Trial Locations

Locations (1)

Queen's Medical Research Institute; 🇬🇧 Edinburgh, Scotland, United Kingdom