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
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)|
|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|
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
- 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.
- 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
- 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.
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
|Contact: Mhairi K Doris, MBChBfirstname.lastname@example.org|
|Contact: Marc Dweck, MBChB, PhDemail@example.com|
|Queen's Medical Research Institute||Recruiting|
|Edinburgh, Scotland, United Kingdom, EH16 4SB|
|Contact: Sponsor Representative 0131 242 3326 firstname.lastname@example.org|
|Principal Investigator:||Mhairi K Doris, MBChB||University of Edinburgh|
|Study Chair:||David E Newby, PhD DM DSc||University of Edinburgh|