Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-02-20 @ 5:57 PM
Study NCT ID:
NCT05672160
Status:
COMPLETED
Last Update Posted:
2023-01-05
First Post:
2023-01-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Overal Survival After TAVI According to Sarcopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 930}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-03', 'studyFirstSubmitDate': '2023-01-03', 'studyFirstSubmitQcDate': '2023-01-03', 'lastUpdatePostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overal survival', 'timeFrame': '11 years', 'description': 'Time from the TAVI procedure to death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sarcopenia', 'survival', 'TAVI'], 'conditions': ['Sarcopenia', 'Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to compare the overal survival after transcatheter aortic valve implantation (TAVI) according to sarcopenia status evaluated from preprocedural CT scans.\n\nThe main question it aims to answer is:\n\n• Is CT evaluated sarcopenia an independent predictor of overal survival after TAVI?', 'detailedDescription': 'The patients suffering from aortic valve stenosis, that are not eligible for cardiosurgery were indicated to miniinvasive transcatheter aortic valve implantation (TAVI). The follow up of 930 patients were done in time interval from 1 to 11 years. In every patient the preprocedural CT scans were done. From these CT scans the L3 cross sections will be used for sarcopenia evaluation. Then we will statisticaly evaluate the overal survival after TAVI procedure in the relation with sarcopenia status. We will answer the main question: Is CT evaluated sarcopenia an independent predictor of overal survival after TAVI?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients indicated for TAVI procedure because of the critical aortic valve stenosis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients udergone TAVI procedure\n\nExclusion Criteria:\n\n* patients with incomplete TAVI procedure, patients without clinical follow up'}, 'identificationModule': {'nctId': 'NCT05672160', 'acronym': 'TAVI_Sarx', 'briefTitle': 'Overal Survival After TAVI According to Sarcopenia', 'organization': {'class': 'OTHER', 'fullName': 'Nemocnice AGEL Trinec-Podlesi a.s.'}, 'officialTitle': 'CT Evaluated Sarcopenia Independently Predicts the Overal Survival After Transcatheter Aortic Valve Implantation', 'orgStudyIdInfo': {'id': 'TAVI_Sarx'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CT evaluated sarcopenia', 'type': 'DIAGNOSTIC_TEST', 'description': 'At L3 level of CT scan we will measure the area and density of muscles and fat tissue. We devided the patients to sarcopenia and non-sarcopenia groups according to these values.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '73961', 'city': 'Třinec', 'state': 'Česká Republika', 'country': 'Czechia', 'facility': 'AGELTrinecPodlesi', 'geoPoint': {'lat': 49.67763, 'lon': 18.67078}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nemocnice AGEL Trinec-Podlesi a.s.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mr. Matej Pekar, MD, PhD', 'investigatorFullName': 'Matej Pekar, MD, PhD', 'investigatorAffiliation': 'Nemocnice AGEL Trinec-Podlesi a.s.'}}}}