Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT06963567
Status:
RECRUITING
Last Update Posted:
2025-05-09
First Post:
2025-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Left Ventricular Thrombus Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-30', 'studyFirstSubmitDate': '2025-04-30', 'studyFirstSubmitQcDate': '2025-04-30', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Result', 'timeFrame': 'From baseline to final 12 month follow up (+/- 2 months)', 'description': 'To measure the composite result of major bleeding (BARC \\>3), stroke and systemic embolisation, and all-cause mortality'}], 'secondaryOutcomes': [{'measure': 'CMR prediction of thrombus', 'timeFrame': 'From baseline to 6 month follow up (+/- 3 months)', 'description': 'To assess CMR based risk prediction model of recurrence of LV thrombus'}, {'measure': 'Blood Test', 'timeFrame': 'From baseline to 6 month follow up (+/- 3 months)', 'description': 'To assess blood test variables in the persistence or recurrence of LV thrombus'}, {'measure': 'Quality of Life Questionnaire', 'timeFrame': 'From baseline to final 12 month follow up (+/- 2 months)', 'description': 'Participants quality of life (QoL) will be measured using European Quality of Life-5 Dimensions - 5 levels (EQ-5D-5L) questionnaire at baseline and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Left Ventricular Thrombus']}, 'descriptionModule': {'briefSummary': 'Left Ventricular Thrombus (LVT) is a blood clot that can develop in a poorly functioning heart. In around 1 in 6 patients who have had a heart attack or diagnosed with heart failure tend to develop blood clots in their main heart chamber.\n\nHaving a blot clot in the main heart chamber can lead to serious complications such as stroke. Treatment for blood clots is blood thinning medications, which if taken for a prolonged period of time can result in bleeding which further complicates treatment. We hope to gather information to better understand the factors associated with blood clot formation and management in the lower left chamber of the heart. This understanding will hopefully enable us and others to improve management of this condition in the future and therefore help the wider population. As part of this study, bloods and scan results will be recorded and we will complete a short quality of life questionnaire. When participants come in for routine MRI scan, we may capture additional images for further research analysis.\n\nA sample of blood no more than one tablespoon will be collected for research analysis at the same time as routine blood test. This will occur at baseline and at around 6 months. At 12 months we will repeat the quality of life questionnaire and collect final data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a diagnosis of LV thrombus in the setting of LV dysfunction (acute myocardial infarction, Ischaemic Cardiomyopathy (ICM), dilated cardiomyopathy (DCM)) will be screened. Patients that do not have LV thrombus but are at risk for developing thrombus such as those with severe LV dysfunction, LV aneurysms, large territory infarcts will also be included.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with LV thrombus or;\n* Patients at risk for developing LV thrombus (e.g severe LV dysfunction, LV aneurysm, MI.\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Unable to consent'}, 'identificationModule': {'nctId': 'NCT06963567', 'acronym': 'LVT Registry', 'briefTitle': 'Left Ventricular Thrombus Registry', 'organization': {'class': 'OTHER', 'fullName': 'Queen Mary University of London'}, 'officialTitle': 'Observational Registry to Determine the Predictors and Outcomes of Patients at Risk of and Diagnosed With Left Ventricular Thrombus', 'orgStudyIdInfo': {'id': '336025'}, 'secondaryIdInfos': [{'id': 'G-002409', 'type': 'OTHER_GRANT', 'domain': 'Barts Charity'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'LV Thrombus (present)', 'description': 'Patients with a diagnosis of LV thrombus in the setting of LV dysfunction (acute myocardial infarction, Ischaemic Cardiomyopathy (ICM), dilated cardiomyopathy (DCM)).'}, {'label': 'LV Thrombus (at risk)', 'description': 'Patients that do not have LV thrombus but are at risk for developing thrombus such as those with severe LV dysfunction, LV aneurysms, large territory infarcts will also be included.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EC1A 7BE', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Mervyn Andiapen', 'role': 'CONTACT', 'email': 'mervyn.andiapen@nhs.net', 'phone': '020 3765 8707'}, {'name': 'Dr Dan Jones', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dr Johanna Jones', 'role': 'SUB_INVESTIGATOR'}], 'facility': "St Bartholomew's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Mary University of London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}