Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-01-31 @ 12:48 AM
Study NCT ID:
NCT02716402
Status:
COMPLETED
Last Update Posted:
2018-08-29
First Post:
2016-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cyanotic Heart Disease and Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D020767', 'term': 'Intracranial Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002542', 'term': 'Intracranial Embolism and Thrombosis'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013923', 'term': 'Thromboembolism'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-27', 'studyFirstSubmitDate': '2016-03-08', 'studyFirstSubmitQcDate': '2016-03-17', 'lastUpdatePostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary and cerebral thrombosis', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Numbers and locations of cerebral and and pulmonary thrombosis, which will be compared with previous examinations'}], 'secondaryOutcomes': [{'measure': 'The total numbers of white matter hyper intensity lessons (WMHL)', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'The numbers of WMHL will be compared with previous scans.'}, {'measure': 'The size of the white matter hyper intensity lessons (WMHL)', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'The size of the WMHL will be compared with previous scans.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cyanotic congenital heart disease', 'pulmonary thrombosis', 'cerebral thrombosis'], 'conditions': ['Thrombosis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to examine previously examined patients with cyanotic congenital heart disease to assess how many of the patients have obtained additional blood clots since they were examined 8 years ago.', 'detailedDescription': "Patients with cyanotic congenital heart disease have reduced oxygen content in their blood due to abnormal connection between the heart's right and left sides. The reduced oxygenation of the blood affects several organs of the body and a common complications to the disease is blood clots. Despite the patients are young and do not have typical risk factors, previous studies have shown, that they have a very high prevalence of thrombosis in the lungs and brain.\n\nThe reason for the increased prevalence of blood clots is not known. A previous study investigated the prevalence of blood clots systematically in patients with cyanotic congenital heart disease and found that approximately 30-40% of the patients had had a clot in the lung or brain. Thus, the study could not predict, when the patient had had a thrombotic event, and most of the patients did not previously had imaging performed. Therefore the aim of this study is to re-examine previously examined cyanotic patients regardless of previous medical history, to assess how many of the patients have obtained additional blood clots since they were examined 8 years ago."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with cyanotic congenital heart disease who have previously participated in the study 'cyanotic congenital heart disease: Hemostatic abnormalities and clinical manifestations' (H-KF-2006-4068).\n* Clinically stable\n\nExclusion Criteria:\n\n* Patients who are not guardians for themselves (not adult).\n* Age \\<18 years."}, 'identificationModule': {'nctId': 'NCT02716402', 'briefTitle': 'Cyanotic Heart Disease and Thrombosis', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Cyanotic Congenital Heart Disease: Prevalence of Pulmonary and Cerebral Thrombi-embolic Events', 'orgStudyIdInfo': {'id': 'H-15012759'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cyanotic congenital heart disease', 'description': 'Patients who previously have been examined with cerebral MRI and V/Q SPECT/CT will be re-examined with cerebral MRI and V/Q SPECT/CT', 'interventionNames': ['Radiation: Cerebral MRI and V/Q SPECT/CT']}], 'interventions': [{'name': 'Cerebral MRI and V/Q SPECT/CT', 'type': 'RADIATION', 'description': 'Cerebral MRI and V/Q SPECT/CT', 'armGroupLabels': ['Cyanotic congenital heart disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Cardiology, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Annette S Jensen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Annette Schophuus Jensen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD MD', 'investigatorFullName': 'Annette Schophuus Jensen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}