PET-MR Imaging of Coronary Atherothrombosis

NCT ID: NCT03618303

Last Updated: 2024-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-16

Study Completion Date

2020-03-24

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Diseases, Ischemic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Interventional

All patients will undergo the same intervention of having a PET-MRI scan and optical coherence tomography.

Group Type EXPERIMENTAL

PET-MRI scan

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Optical Coherence Tomography

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mhairi K Doris, MBChB

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

David E Newby, PhD DM DSc

Role: STUDY_CHAIR

University of Edinburgh

Locations

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Queen's Medical Research Institute

Edinburgh, Scotland, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 27743950 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24345595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24224999 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26363839 (View on PubMed)

Other Identifiers

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AC17091

Identifier Type: -

Identifier Source: org_study_id

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