Intracoronary Thrombus Detection by Magnetic Resonance Imaging

NCT02776657 | Completed

• 1 other identifier: 2015/0421
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Evidence of high intensity signals within the coronary arteries on T1 weighted magnetic resonance imaging.

  Within 72 hours prior to angiography

Secondary Outcomes (4)

• 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

Study Arms (2)

Cohort 1 (Stable Angina)

ACTIVE COMPARATOR

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; Device: Optical Coherence Tomography; Procedure: Invasive Coronary Angiography

Cohort 2 (Acute Coronary Syndrome)

ACTIVE COMPARATOR

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; Device: Optical Coherence Tomography; Procedure: Invasive Coronary Angiography

Interventions

Magnetic Resonance Imaging 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.

Cohort 1 (Stable Angina); Cohort 2 (Acute Coronary Syndrome)

Optical Coherence Tomography DEVICE

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

Cohort 1 (Stable Angina); Cohort 2 (Acute Coronary Syndrome)

Invasive Coronary Angiography PROCEDURE

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

Cohort 1 (Stable Angina); Cohort 2 (Acute Coronary Syndrome)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead

MeSH Terms

Conditions

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

Interventions

Magnetic Resonance Spectroscopy; Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography

Study Officials

• Mhairi K Doris, MBChB

  University of Edinburgh/NHS Lothian

  PRINCIPAL INVESTIGATOR

• David E Newby, PhD

  University of Edinburgh/NHS Lothian

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: May 18, 2016
• Study Start: January 14, 2016
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: June 21, 2024

Record last verified: 2024-06