Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-27 @ 12:48 AM
Study NCT ID:
NCT02608567
Status:
UNKNOWN
Last Update Posted:
2017-02-07
First Post:
2015-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Impact of Myocardial Longitudinal Strain in Asymptomatic Aortic Stenosis: a Meta-Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D058070', 'term': 'Asymptomatic Diseases'}], 'ancestors': [{'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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-06', 'studyFirstSubmitDate': '2015-11-17', 'studyFirstSubmitQcDate': '2015-11-17', 'lastUpdatePostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Combined outcome of death and cardiovascular-related hospitalization (including aortic valve replacement)', 'timeFrame': 'up to 10 years'}], 'secondaryOutcomes': [{'measure': 'Combined outcome of death and cardiovascular-related hospitalization (without aortic valve replacement)', 'timeFrame': 'up to 10 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Aortic Valve Stenosis', 'Asymptomatic Conditions', 'Left Ventricular Function']}, 'descriptionModule': {'briefSummary': 'In patients with asymptomatic aortic stenosis (AS), the prognostic value of reduced left ventricular (LV) ejection fraction is well known. Consequently, there is class I indication for surgery in these patients when LV ejection fraction \\<50%. However, there is growing evidences suggesting that subclinical LV dysfunction, and more particularly longitudinal myocardial dysfunction, may be a powerful early predictor of outcome, even when LV ejection is still preserved. In asymptomatic AS patients with LV ejection fraction \\>50%, a reduced LV global longitudinal strain, as assessed using speckle tracking imaging with transthoracic echocardiography, may be an accurate marker to identify early subclinical LV dysfunction and thus, to improve the risk stratification, the management and the timing of surgery. Several mono-centric observational small studies recently reported results emphasizing the role of LV global longitudinal strain in AS patients. Therefore, a meta-analysis may be conducted and may provide meaningful data. The investigators hypothesized that LV global longitudinal strain is a determinant of outcome in asymptomatic patients with AS and preserved LV ejection fraction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Asymptomatic patients with at least moderate aortic stenosis (mean pressure gradient \\>25mmHg or aortic valve area \\<1.5cm²) and left ventricular ejection fraction \\>50%.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* studies selected in PubMed, Embase, Ovid, and Google Scholar, published between 2005 and 2015 without language restriction according to the following criteria: "aortic stenosis" AND "longitudinal strain"\n\nExclusion Criteria:\n\n* Studies reporting global longitudinal strain derived from VVI and not speckle tracking analysis.\n* Studies with cohort of patients with aortic valve replacement indication'}, 'identificationModule': {'nctId': 'NCT02608567', 'briefTitle': 'Prognostic Impact of Myocardial Longitudinal Strain in Asymptomatic Aortic Stenosis: a Meta-Analysis', 'organization': {'class': 'OTHER', 'fullName': 'European Association of Cardiovascular Imaging'}, 'officialTitle': 'Prognostic Impact of Myocardial Longitudinal Strain in Asymptomatic Aortic Stenosis: a Meta-Analysis', 'orgStudyIdInfo': {'id': 'EACVI-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preserved LV GLS', 'description': 'Patients will be compared according to the level of LV global longitudinal strain (GLS) as derived from transthoracic echocardiography and speckle tracking analysis.\n\nTwo groups will be compared regarding outcome: preserved LV GLS vs. reduced LV GLS. The definition use for reduced LV GLS will be \\>-16%. An optimal threshold would also be calculated and derived from the pooled data.'}, {'label': 'Reduced LV GLS', 'description': 'The definition use for reduced LV GLS will be \\>-16%. An optimal threshold would also be calculated and derived from the pooled data.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '87000', 'city': 'Limoges', 'country': 'France', 'facility': 'CHU LImoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}], 'overallOfficials': [{'name': 'Erwan Donal, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'European Association of Cardiovascular Imaging'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Association of Cardiovascular Imaging', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'EACVI board member - Research&Innovation committee member', 'investigatorFullName': 'Julien Magne', 'investigatorAffiliation': 'European Association of Cardiovascular Imaging'}}}}