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Completed

NCT Number: NCT03618303

PET-MR Imaging of Coronary Atherothrombosis

Heart attacks remain a common cause of death throughout the world. The most common initiating event is the formation of a blood clot within the coronary arteries occluding blood supply to the heart. However, we know that thrombus often occurs within the coronary arteries without causing any symptoms, and may be found in patients with stable angina. We wish to investigate whether blood clots within the coronary arteries can be detected in patients who have had a heart attack and in patients with stable angina using combined positron emission tomography and magnetic resonance (PET-MR) imaging. If possible, this may provide a safe and noninvasive means of identifying patients at higher risk of heart attacks.

The study will be conducted in Edinburgh Heart Centre and a total of 40 participants will be recruited from the cardiology wards, outpatient clinics and day case unit. Participants will be asked to undergo a single PET-MRI scan in addition to invasive angiography as part of standard care (non-research procedure). During the invasive angiogram procedure, an additional imaging test may be performed called Optical Coherence Tomography to provide images from within the heart blood vessels.

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Key information

Conditions

Heart Diseases, Ischemic Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen's Medical Research Institute

Edinburgh, Scotland, EH16 4SB, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Previously diagnosed coronary artery disease undergoing elective invasive angiography OR
  • Admitted with acute coronary syndrome diagnosed by two of the following criteria 1) Elevation of cardiac biomarkers (High sensitivity cardiac troponin I greater than 34 ng/l in men and 16ng/l in women) 2) Symptoms of myocardial ischaemia 3) ECG changes indicative of acute ischaemia

Exclusion criteria

  • Contraindication or inability to undergo MRI scanning
  • Renal failure (estimated glomerular filtration rate less than 30mL/min
  • Undergoing Primary PCI
  • 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

PET-MRI scan

Diagnostic Test

Patients will undergo combined Positron Emission Tomography and Magnetic Resonance Imaging prior to a planned invasive angiogram (performed as standard of care). During the angiogram procedure, an additional imaging test (optical coherence tomography) will be performed.

Other names: Optical Coherence Tomography

Primary outcomes

  1. Plaque-to-myocardial ratio of culprit plaques on T1-weighted imaging

    Time frame: Baseline

    The identification of high risk plaques on T1-weighted MRI to determine whether coronary atherothrombosis can accurately be detected using non-invasive PET-MR imaging.

Secondary outcomes

  1. The correlation between high risk plaques on PET-MR and culprit plaques on invasive angiography in patients with coronary artery disease.

    Time frame: Baseline

    The relationship between positive plaques identified on PET-MR by both T1-weighted MRI and 18F-NaF PET and culprit plaques on invasive angiography

  2. The correlation between coronary plaque thrombosis (MRI), high-risk plaque (PET) and the presence of myocardial infarction on MRI (late enhancement).

    Time frame: Baseline

    The relationship between high risk plaque features on MRI and PET with evidence of myocardial infarction on MRI.

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Official study title

Combined Positron Emission Tomography and Magnetic Resonance Imaging of Coronary Atherothrombosis

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 7, 2018
Registry last updated
May 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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