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PET-MR Imaging of Coronary Atherothrombosis

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ClinicalTrials.gov Identifier: NCT03618303
Recruitment Status : Recruiting
First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh

Brief Summary:

Heart attacks remain a common cause of death in the United Kingdom and throughout the world. The most common initiating event is the formation of a blood clot (thrombus) 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 thrombus 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 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 and will subsequently undergo invasive angiography as part of standard care (non-research procedure). During the invasive angiogram procedure, an additional imaging test will be performed called Optical Coherence Tomography to provide images from within the heart blood vessels. A total of 40 participants will be recruited to this study.


Condition or disease Intervention/treatment Phase
Heart Diseases, Ischemic Diagnostic Test: PET-MRI scan Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Combined Positron Emission Tomography and Magnetic Resonance Imaging of Coronary Atherothrombosis
Actual Study Start Date : July 16, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interventional
All patients will undergo the same intervention of having a PET-MRI scan and optical coherence tomography.
Diagnostic Test: PET-MRI scan
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 Name: Optical Coherence Tomography




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618303


Contacts
Contact: Mhairi K Doris, MBChB 01312426515 mhairi.doris@ed.ac.uk
Contact: Marc Dweck, MBChB, PhD 01312426515 marc.dweck@ed.ac.uk

Locations
United Kingdom
Queen's Medical Research Institute Recruiting
Edinburgh, Scotland, United Kingdom, EH16 4SB
Contact: Sponsor Representative    0131 242 3326    enquiries@accord.scot   
Sponsors and Collaborators
University of Edinburgh
Investigators
Principal Investigator: Mhairi K Doris, MBChB University of Edinburgh
Study Chair: David E Newby, PhD DM DSc University of Edinburgh

Publications:

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03618303     History of Changes
Other Study ID Numbers: AC17091
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases