Clinical trial NCT02776657: Intracoronary Thrombus Detection by Magnetic Resonance Imaging
Official title: Non-Invasive Assessment of Intracoronary Thrombosis in Patients With Acute Coronary Syndrome and Chronic Stable Angina Using Magnetic Resonance Imaging.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Angina Pectoris
Angina, Stable
Angina, Unstable
Myocardial Infarction
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2016-05-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Evidence of high intensity signals within the coronary arteries on T1 weighted magnetic resonance imaging.
timeFrame: Within 72 hours prior to angiography
Secondary outcomes:
measure: The correlation between high risk plaques as determined on MRI with culprit plaques on invasive angiography in patients with acute coronary syndrome (ACS).
timeFrame: Through study completion, an average of 1 year
measure: Incidence of intracoronary thrombosis, as detected by magnetic resonance imaging, in patients with stable coronary artery disease.
timeFrame: Through study completion, an average of 1 year
measure: The change in plaque signal intensity on magnetic resonance imaging at one month following acute coronary syndrome (ACS).
timeFrame: Baseline and 1 month
measure: The change in plaque signal intensity on magnetic resonance imaging at three months following acute coronary syndrome (ACS).
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Edinburgh/NHS Lothian
name: Mhairi K Doris, MBChB
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Edinburgh/NHS Lothian
name: David E Newby, PhD
role: STUDY_DIRECTOR
References: