Intracoronary Thrombus Detection by Magnetic Resonance Imaging

University of Edinburgh

Status: Completed

Conditions: Angina, Stable; Angina Pectoris; Angina, Unstable; Myocardial Infarction

Treatments: Procedure: Invasive Coronary Angiography; Device: Optical Coherence Tomography; Other: Magnetic Resonance Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02776657

2015/0421

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Cohort 1 (Stable Angina)

Active Comparator group

Description:

20 patients with stable angina planned to undergo elective coronary angiography will be recruited and each participant will undergo magnetic resonance imaging (MRI) prior to invasive coronary angiography. During the angiogram, Optical Coherence Tomography (OCT) may be used to identify thrombus within the coronary arteries.

Treatment:

Other: Magnetic Resonance Imaging

Procedure: Invasive Coronary Angiography

Device: Optical Coherence Tomography

Cohort 2 (Acute Coronary Syndrome)

Active Comparator group

Description:

20 patients diagnosed with acute coronary syndrome will be recruited and each participant will undergo magnetic resonance imaging (MRI) prior to invasive coronary angiography. During the angiogram, Optical Coherence Tomography (OCT) may be used to identify thrombus within the coronary arteries. If thrombus is identified, participants will be asked to undergo a repeat MRI scan at one and three months.

Treatment:

Other: Magnetic Resonance Imaging

Procedure: Invasive Coronary Angiography

Device: Optical Coherence Tomography