Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-02-26 @ 2:14 AM
Study NCT ID:
NCT02776657
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2016-04-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intracoronary Thrombus Detection by Magnetic Resonance Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D000789', 'term': 'Angina, Unstable'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-18', 'studyFirstSubmitDate': '2016-04-27', 'studyFirstSubmitQcDate': '2016-05-16', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence of high intensity signals within the coronary arteries on T1 weighted magnetic resonance imaging.', 'timeFrame': 'Within 72 hours prior to angiography'}], 'secondaryOutcomes': [{'measure': 'The correlation between high risk plaques as determined on MRI with culprit plaques on invasive angiography in patients with acute coronary syndrome (ACS).', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Incidence of intracoronary thrombosis, as detected by magnetic resonance imaging, in patients with stable coronary artery disease.', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'The change in plaque signal intensity on magnetic resonance imaging at one month following acute coronary syndrome (ACS).', 'timeFrame': 'Baseline and 1 month'}, {'measure': 'The change in plaque signal intensity on magnetic resonance imaging at three months following acute coronary syndrome (ACS).', 'timeFrame': 'Baseline and 3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Angina Pectoris', 'Angina, Stable', 'Angina, Unstable', 'Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'This study involves the use of Magnetic Resonance Imaging (MRI) to determine whether blood clots can be identified within the blood vessels supplying blood to the heart in patients with angina and who have recently suffered a heart attack.', 'detailedDescription': 'The majority of heart attacks are caused as a result of small blood clots forming within the blood vessels supplying blood to the heart, obstructing blood flow to the heart muscle. Research has also shown that blood clots may form in the blood vessels of the heart without causing a heart attack. At present, blood clots may be identified by techniques used during invasive coronary angiography, but we wish to determine whether a non-invasive test (MRI scanning) can be used to detect small blood clots within the blood vessels supplying blood to the heart muscle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged over 18 years\n* Previously diagnosed coronary artery disease undergoing elective invasive angiography (Cohort 1) OR\n* Admitted with Acute Coronary Syndrome (ACS) diagnosed by two of the following criteria;\n\n 1. Elevation of cardiac biomarkers (high sensitivity troponin I greater than 34ng/l in men and 16ng/l in women).\n 2. Symptoms of myocardial ischaemia\n 3. Electrocardiogram (ECG) changes indicative of acute ischaemia (Cohort 2)\n* Planned invasive coronary angiography\n\nExclusion Criteria:\n\n* Contraindication or inability to undergo MRI scanning\n* Renal failure (estimated glomerular filtration rate less than 30millilitres/minute)\n* Undergoing Primary Percutaneous Coronary Intervention\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': 'NCT02776657', 'briefTitle': 'Intracoronary Thrombus Detection by Magnetic Resonance Imaging', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'Non-Invasive Assessment of Intracoronary Thrombosis in Patients With Acute Coronary Syndrome and Chronic Stable Angina Using Magnetic Resonance Imaging.', 'orgStudyIdInfo': {'id': '2015/0421'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort 1 (Stable Angina)', 'description': '20 patients with stable angina planned to undergo elective coronary angiography will be recruited and each participant will undergo magnetic resonance imaging (MRI) prior to invasive coronary angiography. During the angiogram, Optical Coherence Tomography (OCT) may be used to identify thrombus within the coronary arteries.', 'interventionNames': ['Other: Magnetic Resonance Imaging', 'Device: Optical Coherence Tomography', 'Procedure: Invasive Coronary Angiography']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort 2 (Acute Coronary Syndrome)', 'description': '20 patients diagnosed with acute coronary syndrome will be recruited and each participant will undergo magnetic resonance imaging (MRI) prior to invasive coronary angiography. During the angiogram, Optical Coherence Tomography (OCT) may be used to identify thrombus within the coronary arteries. If thrombus is identified, participants will be asked to undergo a repeat MRI scan at one and three months.', 'interventionNames': ['Other: Magnetic Resonance Imaging', 'Device: Optical Coherence Tomography', 'Procedure: Invasive Coronary Angiography']}], 'interventions': [{'name': 'Magnetic Resonance Imaging', 'type': 'OTHER', 'description': 'Each participant will undergo at least one MRI scan. A small number will be asked to undergo repeat MRI scanning at one and three months following the initial scan.', 'armGroupLabels': ['Cohort 1 (Stable Angina)', 'Cohort 2 (Acute Coronary Syndrome)']}, {'name': 'Optical Coherence Tomography', 'type': 'DEVICE', 'description': 'Participants may undergo Optical Coherence Tomography (OCT) during the angiogram procedure in order to detect thrombus within the coronary arteries.', 'armGroupLabels': ['Cohort 1 (Stable Angina)', 'Cohort 2 (Acute Coronary Syndrome)']}, {'name': 'Invasive Coronary Angiography', 'type': 'PROCEDURE', 'description': 'This will be performed as part of usual care and does not constitute part of the research project.', 'armGroupLabels': ['Cohort 1 (Stable Angina)', 'Cohort 2 (Acute Coronary Syndrome)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mhairi K Doris, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Edinburgh/NHS Lothian'}, {'name': 'David E Newby, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Edinburgh/NHS Lothian'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}