Intracoronary Thrombus Detection by Magnetic Resonance Imaging

June 18, 2024 updated by: University of Edinburgh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evidence of high intensity signals within the coronary arteries on T1 weighted magnetic resonance imaging.
Time Frame: Within 72 hours prior to angiography
Within 72 hours prior to angiography

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2016

Primary Completion (Actual)

March 31, 2017

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

April 27, 2016

First Submitted That Met QC Criteria

May 16, 2016

First Posted (Estimated)

May 18, 2016

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 18, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/0421

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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