Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT03361202
Status:
UNKNOWN
Last Update Posted:
2017-12-04
First Post:
2016-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Microparticles Circulating Plasma Concentration in Atrial Fibrillation After Percutaneous Occluding of the Left Atrium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '4 ml of arterial or venous blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-01', 'studyFirstSubmitDate': '2016-09-12', 'studyFirstSubmitQcDate': '2017-12-01', 'lastUpdatePostDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'levels of microparticles expressing phosphatidylserine in atrial fibrillation group', 'timeFrame': '45 days after Percutaneous Occluding of the Left Atrium.', 'description': 'blood samples analized by flow cytometry'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare levels of differnts types of microparticles circulating before and after percutaneous occluding of the left atrium by patients with atrial fibrillation and patients control.\n\nHypothesis is that prothesis implantation will decrease levels of microparticles circulating in blood circulation because of occluding of the left atrium .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'two groups of patients:\n\n* control\n* atrial fibrillation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\natrial fibrillation group:\n\n* high embolic risk (CHADS-VASC2 score ≥4)\n* formal and final contraindication to anticoagulant therapy\n* no heart thrombus on ETO and TDM before percuraneous occluding\n\ncontrol group:\n\n* suspicion of stable coronary artery disease, coronary angiography scheduled and double platelet aggregation (clopidogrel and aspirine)\n\nExclusion Criteria: for both groups\n\n* congestive heart failure, severe aortic stenosis, EP or TVP early.'}, 'identificationModule': {'nctId': 'NCT03361202', 'acronym': 'MICROPLUG', 'briefTitle': 'Microparticles Circulating Plasma Concentration in Atrial Fibrillation After Percutaneous Occluding of the Left Atrium', 'organization': {'class': 'OTHER', 'fullName': 'Institut Mutualiste Montsouris'}, 'officialTitle': 'Evolution of Microparticles Circulating Plasma Concentration in Atrial Fibrillation After Percutaneous Occluding of the Left Atrium With Prosthesis (Amplatzer® Cardiac Plug)', 'orgStudyIdInfo': {'id': 'CARDIO-01-2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Atrial fibrillation group', 'description': 'blood sampling', 'interventionNames': ['Other: blood sampling']}, {'label': 'control group', 'description': 'blood sampling', 'interventionNames': ['Other: blood sampling']}], 'interventions': [{'name': 'blood sampling', 'type': 'OTHER', 'description': '* atrial fibrillation group:before Percutaneous Occluding of the Left Atrium, at hospital discharge and at J45 follow up\n* control group:before coronary angiography and at hospital discharge.', 'armGroupLabels': ['Atrial fibrillation group', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Institut Mutualiste Montsouris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Nicolas AMABILE, doctor', 'role': 'CONTACT', 'email': 'nicolas.amabile@imm.fr', 'phone': '+33 1 56 61'}, {'name': 'Isabelle SAURET', 'role': 'CONTACT', 'email': 'isabelle.sauret@imm.fr', 'phone': '+33 1 56 61 67 05'}], 'overallOfficials': [{'name': 'Nicolas AMABILE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Mutualiste Montsouris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Mutualiste Montsouris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Société Française de Cardiologie', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}