Intracoronary Thrombus Detection by Magnetic Resonance Imaging

University of Edinburgh40 enrolled

Overview

This study involves the use of Magnetic Resonance Imaging (MRI) to determine whether blood clots can be identified within the blood vessels supplying blood to the heart in patients with angina and who have recently suffered a heart attack.

The majority of heart attacks are caused as a result of small blood clots forming within the blood vessels supplying blood to the heart, obstructing blood flow to the heart muscle. Research has also shown that blood clots may form in the blood vessels of the heart without causing a heart attack. At present, blood clots may be identified by techniques used during invasive coronary angiography, but we wish to determine whether a non-invasive test (MRI scanning) can be used to detect small blood clots within the blood vessels supplying blood to the heart muscle.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Angina Pectoris Angina, Stable Angina, Unstable Myocardial Infarction

Interventions

Magnetic Resonance ImagingOTHER

Each participant will undergo at least one MRI scan. A small number will be asked to undergo repeat MRI scanning at one and three months following the initial scan.

Optical Coherence TomographyDEVICE

Participants may undergo Optical Coherence Tomography (OCT) during the angiogram procedure in order to detect thrombus within the coronary arteries.

Invasive Coronary AngiographyPROCEDURE

This will be performed as part of usual care and does not constitute part of the research project.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged over 18 years * Previously diagnosed coronary artery disease undergoing elective invasive angiography (Cohort 1) OR * Admitted with Acute Coronary Syndrome (ACS) diagnosed by two of the following criteria; 1. Elevation of cardiac biomarkers (high sensitivity troponin I greater than 34ng/l in men and 16ng/l in women). 2. Symptoms of myocardial ischaemia 3. Electrocardiogram (ECG) changes indicative of acute ischaemia (Cohort 2) * Planned invasive coronary angiography Exclusion Criteria: * Contraindication or inability to undergo MRI scanning * Renal failure (estimated glomerular filtration rate less than 30millilitres/minute) * Undergoing Primary Percutaneous Coronary Intervention * 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

Outcomes

Primary Outcomes

Evidence of high intensity signals within the coronary arteries on T1 weighted magnetic resonance imaging.

Time frame: Within 72 hours prior to angiography

Secondary Outcomes

The correlation between high risk plaques as determined on MRI with culprit plaques on invasive angiography in patients with acute coronary syndrome (ACS).

Time frame: Through study completion, an average of 1 year

Incidence of intracoronary thrombosis, as detected by magnetic resonance imaging, in patients with stable coronary artery disease.

Time frame: Through study completion, an average of 1 year

The change in plaque signal intensity on magnetic resonance imaging at one month following acute coronary syndrome (ACS).

Time frame: Baseline and 1 month

The change in plaque signal intensity on magnetic resonance imaging at three months following acute coronary syndrome (ACS).

Time frame: Baseline and 3 months

Data from ClinicalTrials.gov

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