Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-25 @ 3:05 PM
Study NCT ID:
NCT03524768
Status:
COMPLETED
Last Update Posted:
2020-08-20
First Post:
2018-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Microvascular Endothelial Function in a Cohort of Patients With the Cardiac Form of Chronic Chagas Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002598', 'term': 'Chagas Cardiomyopathy'}], 'ancestors': [{'id': 'D014355', 'term': 'Chagas Disease'}, {'id': 'D014352', 'term': 'Trypanosomiasis'}, {'id': 'D056986', 'term': 'Euglenozoa Infections'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-19', 'studyFirstSubmitDate': '2018-04-21', 'studyFirstSubmitQcDate': '2018-05-12', 'lastUpdatePostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelium-dependent skin microvascular function', 'timeFrame': '2 hours', 'description': 'systemic microvascular vasodilation induced by endothelium-dependent agents'}], 'secondaryOutcomes': [{'measure': 'Endothelium-dependent skin capillary density', 'timeFrame': '1 hour', 'description': 'capillary opening induced by post-occlusive reactive hyperemia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endothelial function, microvascular', 'laser speckle contrast imaging', 'capillaroscopy, skin'], 'conditions': ['Chagas Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'The present study aims to evaluate the microvascular endothelial function of a single centre cohort of patients with the cardiac form of Chagas disease, and to search for associations with clinical and laboratory variables.', 'detailedDescription': 'Chagas disease is an endemic anthropozoonosis in South America, caused by the protozoaTrypamosoma cruzi. Between 15 and 17 million people are estimated to be infected by the parasite in South America. During the chronic phase, 30 to 40% of patients develop the cardiac or intestinal forms of the disease. The myocardial involvement is divided in two subtypes, according to the presence or absence of systolic ventricular dysfunction. The first type is characterized by heart failure symptoms. The second is acknowledged by the development of various degrees of atrioventricular blockade and by tachyarrhythmias.\n\nMicrocirculation function is recognized as a fundamental aspect in the pathophysiology of cardiovascular diseases. The identification of endothelial dysfunction by techniques that assess the microvasculature is considered as both a progression and prognostic marker in various conditions, including hypertension, coronary heart disease, and heart failure.\n\nThe effects of T. cruzi infection in vascular function were evaluated in previous studies, performed in animals with acute infection. Previous studies in humans observed medium size vessels (brachial artery), in small groups of patients, most without cardiac dysfunction. There are no studies evaluating the microcirculation of patients with the cardiac form of Chagas disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The present study aims to evaluate the microvascular endothelial function of a single centre cohort of patients presenting with the cardiac form of Chagas disease in the National Institute of Cardiology, Ministry of Health, Rio de Janeiro,, Brazil', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients presenting with Chagas cardiomyopathy\n\nExclusion Criteria:\n\n* diabetes'}, 'identificationModule': {'nctId': 'NCT03524768', 'briefTitle': 'Microvascular Endothelial Function in a Cohort of Patients With the Cardiac Form of Chronic Chagas Disease.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Institute of Cardiology, Laranjeiras, Brazil'}, 'officialTitle': 'Microvascular Endothelial Function in a Cohort of Patients With the Cardiac Form of Chronic Chagas Disease.', 'orgStudyIdInfo': {'id': 'CHAGASKASALTIBIRIÇÁ'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients presenting with Chagas cardiomyopathy', 'description': 'Evaluation of systemic microvascular reactivity using laser speckle contrast imaging Evaluation of skin capillary density using video-capillaroscopy', 'interventionNames': ['Diagnostic Test: skin laser speckle contrast imaging and video-capillaroscopy']}, {'label': 'control group', 'description': 'Evaluation of systemic microvascular reactivity using laser speckle contrast imaging Evaluation of skin capillary density using video-capillaroscopy', 'interventionNames': ['Diagnostic Test: skin laser speckle contrast imaging and video-capillaroscopy']}], 'interventions': [{'name': 'skin laser speckle contrast imaging and video-capillaroscopy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Evaluation of endothelial-dependent microvascular reactivity and capillary recruitment', 'armGroupLabels': ['control group', 'patients presenting with Chagas cardiomyopathy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22240-006', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'National Institute of Cardiology, Ministry of Health, Brazil', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Cardiology, Laranjeiras, Brazil', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Researcher, MD, PhD', 'investigatorFullName': 'Eduardo Tibirica, MD, PhD', 'investigatorAffiliation': 'National Institute of Cardiology, Laranjeiras, Brazil'}}}}