Intracoronary Thrombus Detection by Magnetic Resonance Imaging

Not Applicable

Completed

• Conditions: Angina Pectoris; Angina, Unstable; Myocardial Infarction; Angina, Stable
• Interventions: Other: Magnetic Resonance Imaging; Device: Optical Coherence Tomography; Procedure: Invasive Coronary Angiography

• Registration Number: NCT02776657
• Lead Sponsor: University of Edinburgh

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2016-01-14
• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-05-16
• Study First Posted: 2016-05-18
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2 (Acute Coronary Syndrome)	Optical Coherence Tomography	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.
Cohort 2 (Acute Coronary Syndrome)	Invasive Coronary Angiography	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.
Cohort 1 (Stable Angina)	Magnetic Resonance Imaging	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.
Cohort 1 (Stable Angina)	Optical Coherence Tomography	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.
Cohort 1 (Stable Angina)	Invasive Coronary Angiography	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.
Cohort 2 (Acute Coronary Syndrome)	Magnetic Resonance Imaging	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.

Primary Outcome Measures

Name	Time	Method
Evidence of high intensity signals within the coronary arteries on T1 weighted magnetic resonance imaging.	Within 72 hours prior to angiography

Secondary Outcome Measures

Name	Time	Method
The correlation between high risk plaques as determined on MRI with culprit plaques on invasive angiography in patients with acute coronary syndrome (ACS).	Through study completion, an average of 1 year
The change in plaque signal intensity on magnetic resonance imaging at three months following acute coronary syndrome (ACS).	Baseline and 3 months
Incidence of intracoronary thrombosis, as detected by magnetic resonance imaging, in patients with stable coronary artery disease.	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).	Baseline and 1 month