Intracoronary Thrombus Detection by Magnetic Resonance Imaging

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02776657
• Other study ID #: 2015/0421
• Status: Suspended
• Phase: N/A
• First received: April 27, 2016
• Last updated: May 5, 2017
• Start date: June 2016
• Est. completion date: April 2019

Study information

• Verified date: May 2017
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: April 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Infarction
• Myocardial Infarction

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of high intensity signals within the coronary arteries on T1 weighted magnetic resonance imaging.		Within 72 hours prior to angiography
Secondary	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
Secondary	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
Secondary	The change in plaque signal intensity on magnetic resonance imaging at one month following acute coronary syndrome (ACS).		Baseline and 1 month
Secondary	The change in plaque signal intensity on magnetic resonance imaging at three months following acute coronary syndrome (ACS).		Baseline and 3 months