Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2025-12-25 @ 11:52 AM
Study NCT ID:
NCT04440761
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2020-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Barts-MINOCA Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D003075', 'term': 'Coitus'}, {'id': 'D017566', 'term': 'Microvascular Angina'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000787', 'term': 'Angina Pectoris'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-09-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2020-06-15', 'studyFirstSubmitQcDate': '2020-06-17', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'Assessment of mortality'}, {'measure': 'Mortality', 'timeFrame': '1 year', 'description': 'Assessment of mortality'}, {'measure': 'Formal diagnosis made of the cause of troponin rise', 'timeFrame': 'Baseline', 'description': 'Diagnosis'}, {'measure': 'Timing of diagnosis made of the cause of troponin rise', 'timeFrame': 'Baseline', 'description': 'Time to first diagnosis'}, {'measure': 'Questionnaire to assess change in symptoms at 2 months post-initial review in clinic/ward', 'timeFrame': '2 months', 'description': 'Change in symptoms assessed by Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myocardial Infarction', 'Gender', 'Coronary Microvascular Disease']}, 'descriptionModule': {'briefSummary': 'The last 15 years the introduction of primary angioplasty has radically improved outcomes for acute myocardial infarction (AMI). However, the system wide availability of prompt investigation has revealed an important group of patients where progress has stalled, the diagnosis is unclear and therapeutic approaches are uncertain. Myocardial infarction with non-obstructive coronary arteries (MINOCA) is found in 1 - 13% of all patients with a clinical diagnosis of AMI.\n\nThese patients present a therapeutic predicament since coronary revascularization is not appropriate. Guidelines do not exist for their management - yet the condition is not benign - the 12-month prognosis, although better than obstructive coronary artery disease patients is still guarded with recent data suggesting many questions remain unanswered.', 'detailedDescription': 'This study utilises a prospectively collected clinical database. All patients referred to the Interventional Cardiology team are included onto this database. No patients will be contacted solely for research purposes. Patients will not have any investigations/procedures performed for research purposes. All data will only be available for access by named members of the Interventional Cardiology team. Data will be anonymised by the clinical care team and passed onto the research team before it is used and no patient identifiable information will be used in the analysis of the study or the publications of its results.\n\nThe database started in April 2015 and has collected data on all patients so far and will continue to do so for the duration of clinical work by the Interventional Cardiology team. As a result this study will continue indefinitely.\n\nThis study will include all patients admitted to or reviewed in clinic at Barts Health NHS Trust with either a diagnosis of MINOCA or who do not have a clear cause of a troponin rise. These patients range from young adults to the elderly and will include any patient ≥16 years of age. Patients who are followed up with and without any intervention (i.e. both medically managed patients as well as patients undergoing intervention) are equally as important and therefore the investigators shall include both groups of patients.\n\nPatients will be included from referrals made by other clinicians either as in or outpatients. All these patients have their clinical data captured on a database or hospital based clinical programme.\n\nThis study aims to assess, in a real-world setting, the safety, efficacy and feasibility of further investigations in patients diagnosed with MINOCA among all patients with coronary artery disease.\n\nThe study will test various hypothesis including but not limited to:\n\n1. The efficacy of diagnosis rates of CMR in patients diagnosed with MINOCA\n2. Outcomes in patients diagnosed with MINOCA treated medically\n3. Long-term outcome of patients diagnosed with MINOCA'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will include all patients admitted to or reviewed in clinic at Barts Health NHS Trust with either a diagnosis of MINOCA or who do not have a clear cause of a troponin rise. These patients range from young adults to the elderly and will include any patient ≥16 years of age. Patients who are followed up with and without any intervention (i.e. both medically managed patients as well as patients undergoing intervention) are equally as important and therefore we shall include both groups of patients.\n\nPatients will be included from referrals made by other clinicians either as in or outpatients. All these patients have their clinical data captured on a database or hospital based clinical programme.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both male and female patients ≥16 years of age will be included\n* All patients will have a diagnosis MINOCA. Any patient who does not have a clear cause of troponin rise\n\nExclusion Criteria:\n\n* Patients \\<16 years will not be included in this study.'}, 'identificationModule': {'nctId': 'NCT04440761', 'briefTitle': 'Barts-MINOCA Registry', 'organization': {'class': 'OTHER', 'fullName': 'Queen Mary University of London'}, 'officialTitle': 'Barts Myocardial Infarction With Non-Obstructed Coronary Arteries (MINOCA) Registry', 'orgStudyIdInfo': {'id': 'REDA: 130386'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Troponin rise/ diagnosis of MINOCA', 'description': 'This study aims to assess, in a real-world setting, the safety, efficacy and feasibility of further investigations in patients diagnosed with MINOCA among all patients with coronary artery disease.', 'interventionNames': ['Other: Observation only']}], 'interventions': [{'name': 'Observation only', 'type': 'OTHER', 'description': 'Observation only', 'armGroupLabels': ['Troponin rise/ diagnosis of MINOCA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Dr Anne-Marie Beirne', 'role': 'CONTACT'}], 'facility': 'Barts Health NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Daniel Jones, MBBS, PhD', 'role': 'CONTACT', 'email': 'dan.jones8@nhs.net', 'phone': '020 7377 7000'}, {'name': 'Krishnaraj Rathod, MBBS, PhD', 'role': 'CONTACT', 'email': 'krishnaraj.rathod1@nhs.net', 'phone': '020 7377 7000'}], 'overallOfficials': [{'name': 'Daniel Jones, MBBS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queen Mary University of London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Mary University of London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}