Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-02-18 @ 11:00 AM
Study NCT ID:
NCT03618303
Status:
COMPLETED
Last Update Posted:
2024-05-21
First Post:
2018-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PET-MR Imaging of Coronary Atherothrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-20', 'studyFirstSubmitDate': '2018-07-31', 'studyFirstSubmitQcDate': '2018-07-31', 'lastUpdatePostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plaque-to-myocardial ratio of culprit plaques on T1-weighted imaging', 'timeFrame': 'Baseline', '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.'}], 'secondaryOutcomes': [{'measure': 'The correlation between high risk plaques on PET-MR and culprit plaques on invasive angiography in patients with coronary artery disease.', 'timeFrame': 'Baseline', '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'}, {'measure': 'The correlation between coronary plaque thrombosis (MRI), high-risk plaque (PET) and the presence of myocardial infarction on MRI (late enhancement).', 'timeFrame': 'Baseline', 'description': 'The relationship between high risk plaque features on MRI and PET with evidence of myocardial infarction on MRI.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Diseases, Ischemic']}, 'referencesModule': {'references': [{'pmid': '27743950', 'type': 'BACKGROUND', '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.'}, {'pmid': '24345595', 'type': 'BACKGROUND', '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.'}, {'pmid': '24224999', 'type': 'BACKGROUND', '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.'}, {'pmid': '26363839', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previously diagnosed coronary artery disease undergoing elective invasive angiography OR\n* 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\n\nExclusion Criteria:\n\n* Contraindication or inability to undergo MRI scanning\n* Renal failure (estimated glomerular filtration rate less than 30mL/min\n* Undergoing Primary PCI\n* Ongoing myocardial ischaemia or dynamic ECG changes\n* Inability to provide informed consent\n* Known allergy to gadolinium based contrast\n* Women who are pregnant, breastfeeding or of child-bearing potential'}, 'identificationModule': {'nctId': 'NCT03618303', 'briefTitle': 'PET-MR Imaging of Coronary Atherothrombosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'Combined Positron Emission Tomography and Magnetic Resonance Imaging of Coronary Atherothrombosis', 'orgStudyIdInfo': {'id': 'AC17091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional', 'description': 'All patients will undergo the same intervention of having a PET-MRI scan and optical coherence tomography.', 'interventionNames': ['Diagnostic Test: PET-MRI scan']}], 'interventions': [{'name': 'PET-MRI scan', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Optical Coherence Tomography'], '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.', 'armGroupLabels': ['Interventional']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EH16 4SB', 'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': "Queen's Medical Research Institute", 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'Mhairi K Doris, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Edinburgh'}, {'name': 'David E Newby, PhD DM DSc', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Edinburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}