PET-MR Imaging of Coronary Atherothrombosis
Primary Purpose
Heart Diseases, Ischemic
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
PET-MRI scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Diseases, Ischemic
Eligibility 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
Sites / Locations
- Queen's Medical Research InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interventional
Arm Description
All patients will undergo the same intervention of having a PET-MRI scan and optical coherence tomography.
Outcomes
Primary Outcome Measures
Plaque-to-myocardial ratio of culprit plaques on T1-weighted imaging
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
The correlation between high risk plaques on PET-MR and culprit plaques on invasive angiography in patients with coronary artery disease.
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).
The relationship between high risk plaque features on MRI and PET with evidence of myocardial infarction on MRI.
Full Information
NCT ID
NCT03618303
First Posted
July 31, 2018
Last Updated
January 30, 2019
Sponsor
University of Edinburgh
1. Study Identification
Unique Protocol Identification Number
NCT03618303
Brief Title
PET-MR Imaging of Coronary Atherothrombosis
Official Title
Combined Positron Emission Tomography and Magnetic Resonance Imaging of Coronary Atherothrombosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 16, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Anticipated)
Study Completion Date
August 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases, Ischemic
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional
Arm Type
Experimental
Arm Description
All patients will undergo the same intervention of having a PET-MRI scan and optical coherence tomography.
Intervention Type
Diagnostic Test
Intervention Name(s)
PET-MRI scan
Other Intervention Name(s)
Optical Coherence Tomography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plaque-to-myocardial ratio of culprit plaques on T1-weighted imaging
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
The correlation between high risk plaques on PET-MR and culprit plaques on invasive angiography in patients with coronary artery disease.
Description
The relationship between positive plaques identified on PET-MR by both T1-weighted MRI and 18F-NaF PET and culprit plaques on invasive angiography
Time Frame
Baseline
Title
The correlation between coronary plaque thrombosis (MRI), high-risk plaque (PET) and the presence of myocardial infarction on MRI (late enhancement).
Description
The relationship between high risk plaque features on MRI and PET with evidence of myocardial infarction on MRI.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mhairi K Doris, MBChB
Phone
01312426515
Email
mhairi.doris@ed.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Dweck, MBChB, PhD
Phone
01312426515
Email
marc.dweck@ed.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mhairi K Doris, MBChB
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David E Newby, PhD DM DSc
Organizational Affiliation
University of Edinburgh
Official's Role
Study Chair
Facility Information:
Facility Name
Queen's Medical Research Institute
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH16 4SB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sponsor Representative
Phone
0131 242 3326
Email
enquiries@accord.scot
12. IPD Sharing Statement
Citations:
PubMed Identifier
27743950
Citation
Xie Y, Kim YJ, Pang J, Kim JS, Yang Q, Wei J, Nguyen CT, Deng Z, Choi BW, Fan Z, Bairey Merz CN, Shah PK, Berman DS, Chang HJ, Li D. Coronary Atherosclerosis T1-Weighed Characterization With Integrated Anatomical Reference: Comparison With High-Risk Plaque Features Detected by Invasive Coronary Imaging. JACC Cardiovasc Imaging. 2017 Jun;10(6):637-648. doi: 10.1016/j.jcmg.2016.06.014. Epub 2016 Oct 12.
Results Reference
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PubMed Identifier
24345595
Citation
Noguchi T, Kawasaki T, Tanaka A, Yasuda S, Goto Y, Ishihara M, Nishimura K, Miyamoto Y, Node K, Koga N. High-intensity signals in coronary plaques on noncontrast T1-weighted magnetic resonance imaging as a novel determinant of coronary events. J Am Coll Cardiol. 2014 Mar 18;63(10):989-99. doi: 10.1016/j.jacc.2013.11.034. Epub 2013 Dec 15.
Results Reference
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PubMed Identifier
24224999
Citation
Joshi NV, Vesey AT, Williams MC, Shah AS, Calvert PA, Craighead FH, Yeoh SE, Wallace W, Salter D, Fletcher AM, van Beek EJ, Flapan AD, Uren NG, Behan MW, Cruden NL, Mills NL, Fox KA, Rudd JH, Dweck MR, Newby DE. 18F-fluoride positron emission tomography for identification of ruptured and high-risk coronary atherosclerotic plaques: a prospective clinical trial. Lancet. 2014 Feb 22;383(9918):705-13. doi: 10.1016/S0140-6736(13)61754-7. Epub 2013 Nov 11.
Results Reference
background
PubMed Identifier
26363839
Citation
Matsumoto K, Ehara S, Hasegawa T, Sakaguchi M, Otsuka K, Yoshikawa J, Shimada K. Localization of Coronary High-Intensity Signals on T1-Weighted MR Imaging: Relation to Plaque Morphology and Clinical Severity of Angina Pectoris. JACC Cardiovasc Imaging. 2015 Oct;8(10):1143-1152. doi: 10.1016/j.jcmg.2015.06.013. Epub 2015 Sep 9.
Results Reference
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PET-MR Imaging of Coronary Atherothrombosis
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