Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-04 @ 2:54 AM
Study NCT ID:
NCT01745666
Status:
UNKNOWN
Last Update Posted:
2016-10-05
First Post:
2012-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Epinephrine and Exercise Test in QT Long Syndrome Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029597', 'term': 'Romano-Ward Syndrome'}, {'id': 'D008133', 'term': 'Long QT Syndrome'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-04', 'studyFirstSubmitDate': '2012-12-05', 'studyFirstSubmitQcDate': '2012-12-07', 'lastUpdatePostDateStruct': {'date': '2016-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to evaluate the best stress exam (exercise test OR epinephrine test)to unmask long QT syndrome.', 'timeFrame': 'day 1', 'description': 'Exercise test and epinephrine test will be done at inclusion (day 1). The primary outcome of this study is to evaluate the best stress exam (exercise test versus epinephrine test), defined by a "positive" test to unmask long QT syndrome. Test is positive when QT interval lengthens 30 ms At the end of study inclusions, two reviewers will analyse, independently, electrocardiograms resulting from these tests to determine for each patient if a test was positive and which one. These reviewers will do this job without being informed of the patient status (mutated patient or not mutated patient (control)).'}], 'secondaryOutcomes': [{'measure': 'to evaluate each test characteristics', 'timeFrame': 'Day 1', 'description': 'Exercise test and epinephrine test will be done at inclusion (day 1). The secondary outcome is to evaluate each test (exercise test and epinephrine test) characteristics. At the end of study inclusions, two reviewers will independently analyse electrocardiograms resulting from these tests to evaluate their characteristics.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Long QT syndrome, stress tests'], 'conditions': ['Long QT Syndrome Type 1 or 2']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the best stress exam to unmask long QT in patient with KCNQ1 or KCNH2 mutation without long QT interval in rest electrocardiogram.', 'detailedDescription': '65 patients with KCNQ1 or KCNH2 mutation presenting QTc interval \\<470msec and 65 patients without KCNQ1 or KCNH2 mutation presenting QTc interval \\<470msec will be included.\n\nAll patients will have the 2 tests: exercise test and epinephrine test, in one half day.\n\nAt the end of the inclusions, two experts will examine examens results without knowing in which arm (mutated or not) the patient belongs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with QTc\\<470 msec, and with molecular analysis (KCNQ1 or KCNH2 genes) performed in order to include 65 patients with KCNQ1 or KCNH2 mutation and 65 patients without KCNQ1 or KCNH2 mutation (controls).\n\nExclusion Criteria:\n\n* QTc interval \\>470msec\n* Treatment interfering with cardiac repolarisation\n* Under 15 years old\n* Pregnant women\n* Contraindication to exercise or epinephrine tests\n* Patients without social coverage'}, 'identificationModule': {'nctId': 'NCT01745666', 'acronym': 'QT long', 'briefTitle': 'Comparison Between Epinephrine and Exercise Test in QT Long Syndrome Patients', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Comparison Between Epinephrine and Exercise Test in QT Long Syndrome Patients With KCNQ1 or KCNH2 Mutation Without Long QT Interval in Rest ECG', 'orgStudyIdInfo': {'id': 'RC11_0160'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients with KCNQ1 or KCNH2 mutation', 'interventionNames': ['Other: exercise test', 'Other: Epinephrine test']}, {'type': 'OTHER', 'label': 'patients WITHOUT KCNQ1 or KCNH2 mutation (control group)', 'interventionNames': ['Other: exercise test', 'Other: Epinephrine test']}], 'interventions': [{'name': 'exercise test', 'type': 'OTHER', 'description': 'Exercise test : Bruce protocol : exercise during 7 minutes, and rest during 6 minutes with registering of the electrocardiograms.', 'armGroupLabels': ['patients WITHOUT KCNQ1 or KCNH2 mutation (control group)', 'patients with KCNQ1 or KCNH2 mutation']}, {'name': 'Epinephrine test', 'type': 'OTHER', 'description': 'Epinephrine test : 1 hour after exercise test : epinephrine infusion during 20 minutes, and monitoring during 30 minutes after stop infusion with registering of electrocardiograms.', 'armGroupLabels': ['patients WITHOUT KCNQ1 or KCNH2 mutation (control group)', 'patients with KCNQ1 or KCNH2 mutation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33604', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frederic SACHER, PH', 'role': 'CONTACT', 'email': 'frederic.sacher@chu-bordeaux.fr', 'phone': '+33 5 57 65 64 71'}, {'name': 'Frederic SACHER, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bordeaux Universitary Hospital', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '13385', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Claude DEHARO, PU-PH', 'role': 'CONTACT', 'email': 'jean-claude.deharo@ap-hm.fr'}, {'name': 'Eric PEYROUSE, PH', 'role': 'CONTACT', 'email': 'eric.peyrouse@ap-hm.fr'}, {'name': 'Jean-Claude DEHARO, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Eric PEYROUSE, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Marseille Universitary Hospital', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Luc PASQUIE, PH', 'role': 'CONTACT', 'email': 'jl-pasquie@chu-montpellier.fr'}, {'name': 'Jean-Luc PASQUIE, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44093', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Vincent PROBST, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nantes Universitary Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '35033', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe MABO, PU-PH', 'role': 'CONTACT', 'email': 'philippe.mabo@chu-rennes.fr'}, {'name': 'Philippe MABO, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rennes Universitary Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76031', 'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frederic ANSELME, PH', 'role': 'CONTACT', 'email': 'frederic.anselme@chu-rouen.fr'}, {'name': 'Frederic ANSELME, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe MAURY, PH', 'role': 'CONTACT', 'email': 'maury.p@chu-toulouse.fr'}, {'name': 'Philippe MAURY, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37170', 'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'BABUTY Dominique, PU-PH', 'role': 'CONTACT', 'email': 'd.babuty@chu-tours.fr'}, {'name': 'Dominique BABUTY, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Vincent PROBST, PU-PH', 'role': 'CONTACT', 'email': 'vincent.probst@chu-nantes.fr', 'phone': '+33 2 40 16 57 00'}, {'name': 'Eric DELANNOY, PH', 'role': 'CONTACT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}