PET-MR Imaging of Coronary Atherothrombosis

Heart Diseases, Ischemic Clinical Trial

Official title:

Combined Positron Emission Tomography and Magnetic Resonance Imaging of Coronary Atherothrombosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03618303
• Other study ID #: AC17091
• Status: Recruiting
• Phase: N/A
• Start date: July 16, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: January 2019
• Source: University of Edinburgh
• Contact: Mhairi K Doris, MBChB
• Phone: 01312426515
• Email: mhairi.doris[@]ed.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Heart Diseases, Ischemic
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Queen's Medical Research Institute	Edinburgh	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. — View 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):1143-52. doi: 10.1016/j.jcmg.2015.06.013. Epub 2015 Sep 9. — View 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. — View 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 T(1)-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Secondary	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	Baseline
Secondary	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.	Baseline