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Completed

NCT Number: NCT02776657

Intracoronary Thrombus Detection by 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • 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

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

Treatment and study plan

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.

optical coherence tomography

Device

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

invasive coronary angiography

Procedure

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

Primary outcomes

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

    Time frame: Within 72 hours prior to angiography

Secondary outcomes

  1. 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

  2. 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

  3. The change in plaque signal intensity on magnetic resonance imaging at one month following acute coronary syndrome (ACS).

    Time frame: Baseline and 1 month

  4. The change in plaque signal intensity on magnetic resonance imaging at three months following acute coronary syndrome (ACS).

    Time frame: Baseline and 3 months

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 18, 2016
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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