Intracoronary Thrombus Detection by Magnetic Resonance Imaging

NCT ID: NCT02776657

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-14
• Study Completion Date: 2017-03-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Magnetic Resonance Imaging

Intervention Type: OTHER

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 Tomography

Intervention Type: DEVICE

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

Invasive Coronary Angiography

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

Magnetic Resonance Imaging

Intervention Type: OTHER

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 Tomography

Intervention Type: DEVICE

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

Invasive Coronary Angiography

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: OTHER

Optical Coherence Tomography

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

Intervention Type: DEVICE

Invasive Coronary Angiography

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mhairi K Doris, MBChB

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh/NHS Lothian

David E Newby, PhD

Role: STUDY_DIRECTOR

University of Edinburgh/NHS Lothian

Other Identifiers

2015/0421

Identifier Type: -

Identifier Source: org_study_id