Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-03-03 @ 3:54 PM
Study NCT ID:
NCT03305094
Status:
UNKNOWN
Last Update Posted:
2023-03-10
First Post:
2017-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], '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': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participant is blinded to group assignment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled prospective trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-09', 'studyFirstSubmitDate': '2017-09-28', 'studyFirstSubmitQcDate': '2017-10-03', 'lastUpdatePostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in biochemical markers of myocardial ischemia', 'timeFrame': '6, 12, 24 and 48 hours post-operatively', 'description': 'Troponin T-HS and CK-MB concentration'}], 'secondaryOutcomes': [{'measure': 'Post-operative complications', 'timeFrame': 'post-operatively until 30 days', 'description': 'Monitoring the safety of the strategy by monitoring post-operative complications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Remote ischemic preconditioning', 'Myocardial infarction', 'Cardiac surgery'], 'conditions': ['Aortic Valve Stenosis', 'Cardiopulmonary Bypass']}, 'descriptionModule': {'briefSummary': 'The study objective is to verify if a non-invasive remote ischemic preconditioning procedure (blood pressure cuff on the arm) is cardioprotective when applied before an aortic valve replacement surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned isolated aortic valve replacement (stenosis based)\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Pregnancy\n* Left ventricular dysfunction (LVEF\\< 50%)\n* Myocardial Infarct (\\< 7days)\n* Coronary artery disease (documented with \\>50% stenosis)\n* Coronary artery bypass grafting\n* Chronic renal insufficiency (creatinine \\>175 mmol/L or dialysis)\n* Endocarditis\n* Sternotomy redo\n* Deep vein thrombosis to the compressed limb\n* Emergency procedure\n* TAVI procedure\n* Planned off pump coronary artery bypass\n* MAZE procedure'}, 'identificationModule': {'nctId': 'NCT03305094', 'briefTitle': 'The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery : a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CONDOR-21082'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Sham remote ischemic preconditioning on the right arm is induced with a blood pressure cuff inflation at 20 mm Hg for 5 min and followed by a 5 min reperfusion at 0 mm Hg. The sham ischemia-reperfusion cycle is performed 3 times for a total of 30 min. This procedure is done after anesthetic induction, but before the patient is placed on cardiopulmonary bypass.\n\nA 20 mm Hg blood pressure cuff on the right arm does not induce ischemia.', 'interventionNames': ['Procedure: Blood pressure cuff inflation']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Remote ischemic preconditioning on the right arm is induced with a blood pressure cuff inflation at 200 mm Hg for 5 min and followed by a 5 min reperfusion at 0 mm Hg. The ischemia-reperfusion cycle is performed 3 times for a total of 30 min. This procedure is done after anesthetic induction, but before the patient is placed on cardiopulmonary bypass.', 'interventionNames': ['Procedure: Blood pressure cuff inflation']}], 'interventions': [{'name': 'Blood pressure cuff inflation', 'type': 'PROCEDURE', 'description': 'Cuff pressure for ischemia sham is 20 mm Hg, ischemia is 200 mm Hg and reperfusion is 0 mm Hg', 'armGroupLabels': ['Control group', 'Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hôpital Laval', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Pierre Voisine, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Laval'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'collaborators': [{'name': "Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiac surgeon', 'investigatorFullName': 'Pierre Voisine', 'investigatorAffiliation': 'Laval University'}}}}