Ignite Creation Date:
2025-12-25 @ 4:20 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT01620320
Status:
WITHDRAWN
Last Update Posted:
2013-06-26
First Post:
2010-07-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stress Echocardiography Versus Coronary Angiography for Left Main Stenosis Detection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003251', 'term': 'Constriction, Pathologic'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No Funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-24', 'studyFirstSubmitDate': '2010-07-16', 'studyFirstSubmitQcDate': '2012-06-14', 'lastUpdatePostDateStruct': {'date': '2013-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between stress echocardiography results for the detection of left main prosthesis stenosis with coronary angiogram results.', 'timeFrame': '9 to 12 months after left main angioplasty'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Left main coronary artery', 'Coronary artery disease', 'Stress echography', 'Intrastent stenosis'], 'conditions': ['Left Main Coronary Artery Disease', 'Stenosis']}, 'descriptionModule': {'briefSummary': 'Left main stenosis use to be treated by bypass but with the improvement of angioplasty techniques, an increasing number of patients are submit to left main coronary angioplasty. Consequences of left main intra stent stenosis can be disastrous yet, for the moment, no precise recommendation concerning the follow up of these patients exist. The investigators ought to determine if stress echocardiography can predict left main intra stent stenosis as well (non inferiorly)as control angiography that use to be done.', 'detailedDescription': 'All patients of the study will pass coronary angiogram and stress echocardiography (treadmill of dobutamine).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting to teaching hospital or stent from community hospitals to teaching hospital and having left main angioplasty', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients over 18 years old able to give consent and having had left main angioplasty.\n\nExclusion Criteria:\n\n* Bypass on the left anterior descending coronary artery or left circumflex (" protected left main ")\n* Treating physician judge that angiography need to be done straightaway\n* Follow up elsewhere than the CHUS\n* Patient refusal\n* Pregnant women\n* Stress echo contraindication(Severe high blood pressure or malignant arrhythmia)or condition that limits interpretation (Left bundle branch block or pacemaker rhythm)'}, 'identificationModule': {'nctId': 'NCT01620320', 'acronym': 'ESTRIE-TC', 'briefTitle': 'Stress Echocardiography Versus Coronary Angiography for Left Main Stenosis Detection', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': "Évaluation de l'Echographie de Stress Par Comparaison à la Coronarographie Comme Outil Non Invasif de détection de la resténose Intra endoprothèse du Tronc Commun", 'orgStudyIdInfo': {'id': 'projet #10-011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stress echography', 'description': 'Nine to twelve months after their left main angioplasty, patients will go through a stress echo and then the usual control angiography (done routinely in most patient in our center). Patients will act as their own control.', 'interventionNames': ['Other: Stress echocardiography']}], 'interventions': [{'name': 'Stress echocardiography', 'type': 'OTHER', 'otherNames': ['Dobutamine echocardiography', 'Treadmill echocardiography'], 'description': 'Patients able to exercise will have a treadmill test + echography; the others will have a dobutamine echography.', 'armGroupLabels': ['Stress echography']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Sherbrooke, departement de cardiologie', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Paul Farand, Cardiologue', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre de recherche du Centre hospitalier universitaire de Sherbrooke'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Paul Farand', 'investigatorAffiliation': 'Université de Sherbrooke'}}}}