Intracoronary Thrombus Detection by Magnetic Resonance Imaging

Sponsor

University of Edinburgh (Other)

Overall Status

Suspended

CT.gov ID

NCT02776657

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Angina Pectoris Angina, Stable Angina, Unstable Myocardial Infarction	Other: Magnetic Resonance Imaging Device: Optical Coherence Tomography Procedure: Invasive Coronary Angiography	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Non-Invasive Assessment of Intracoronary Thrombosis in Patients With Acute Coronary Syndrome and Chronic Stable Angina Using Magnetic Resonance Imaging.

Actual Study Start Date :

Jun 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cohort 1 (Stable Angina) 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.	Other: Magnetic Resonance Imaging 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. Device: Optical Coherence Tomography Participants may undergo Optical Coherence Tomography (OCT) during the angiogram procedure in order to detect thrombus within the coronary arteries. Procedure: Invasive Coronary Angiography This will be performed as part of usual care and does not constitute part of the research project.
Active Comparator: Cohort 2 (Acute Coronary Syndrome) 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.	Other: Magnetic Resonance Imaging 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. Device: Optical Coherence Tomography Participants may undergo Optical Coherence Tomography (OCT) during the angiogram procedure in order to detect thrombus within the coronary arteries. Procedure: Invasive Coronary Angiography This will be performed as part of usual care and does not constitute part of the research project.

Arm

Intervention/Treatment

Active Comparator: Cohort 1 (Stable Angina)

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.

Other: Magnetic Resonance Imaging

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.

Device: Optical Coherence Tomography

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

Procedure: Invasive Coronary Angiography

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

Active Comparator: Cohort 2 (Acute Coronary Syndrome)

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.

Other: Magnetic Resonance Imaging

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.

Device: Optical Coherence Tomography

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

Procedure: Invasive Coronary Angiography

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]
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]
The change in plaque signal intensity on magnetic resonance imaging at three months following acute coronary syndrome (ACS). [Baseline and 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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;

Elevation of cardiac biomarkers (high sensitivity troponin I greater than 34ng/l in men and 16ng/l in women).
Symptoms of myocardial ischaemia
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Edinburgh

Investigators

Principal Investigator: Mhairi K Doris, MBChB, University of Edinburgh/NHS Lothian
Study Director: David E Newby, PhD, University of Edinburgh/NHS Lothian