Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT05342220
Status:
COMPLETED
Last Update Posted:
2024-07-09
First Post:
2022-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Ischemic Preconditioning on Atrial Fibrillation After Electrocardioversion
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-07', 'studyFirstSubmitDate': '2022-04-06', 'studyFirstSubmitQcDate': '2022-04-15', 'lastUpdatePostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with recurrence of atrial fibrillation 30 days after electrical cardioversion', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Number of patients with short-term cardioversion success', 'timeFrame': '30 seconds', 'description': 'Sinus rhythm lasting \\> 30 seconds after electrocardioversion'}, {'measure': 'Minimum energy required for successful electrocardioversion (in Joule)', 'timeFrame': '30 days'}, {'measure': 'Cumulative energy applied for successfull electrocardioversion (in Joule)', 'timeFrame': '30 days'}, {'measure': 'Cumulative number of shocks delivered for successfull electrocardioversion', 'timeFrame': '30 days'}, {'measure': 'Number of patients experiencing death from any cause, stroke /transient ischemic attack, relevant post-ECV arrhythmia and procedure-associated complications', 'timeFrame': '30 days', 'description': 'Safety endpoint'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '40433224', 'type': 'DERIVED', 'citation': 'Keim C, Wiedenmann L, Schubert T, Rothe M, Dobre BC, Kaess BM, Ehrlich JR, Boehmer AA. Remote Ischemic Preconditioning for Electrical Cardioversion of Atrial Fibrillation-the Prospective Randomized PRECON-AF Study. CJC Open. 2025 Mar 10;7(5):571-578. doi: 10.1016/j.cjco.2025.03.004. eCollection 2025 May.'}]}, 'descriptionModule': {'briefSummary': 'Remote ischemic preconditioning is one way to influence the success of therapy in cardiovascular patients. By means of remote ischemic preconditioning the incidence of atrial fibrillation after cardiac surgery was reduced by 54%. The investigators aim to investigate the effect of ischemic preconditioning in an easy-to-perform protocol with regard to the recurrence of atrial fibrillation after electrical cardioversion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with paroxysmal or persistent atrial fibrillation who give written informed consent to participate in the study\n* Age \\> 18 years\n* Consent capacity\n\nExclusion Criteria:\n\n* Age under 18 years\n* Pregnancy\n* Lack of consent capacity'}, 'identificationModule': {'nctId': 'NCT05342220', 'acronym': 'PRECON-AF', 'briefTitle': 'Effect of Ischemic Preconditioning on Atrial Fibrillation After Electrocardioversion', 'organization': {'class': 'OTHER', 'fullName': 'St. Josefs-Hospital Wiesbaden GmbH'}, 'officialTitle': 'Effect of Ischemic Preconditioning on Relapse of Nonvalvular Atrial Fibrillation After Electrocardioversion', 'orgStudyIdInfo': {'id': 'PRECON'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Remote Ischemic Preconditioning', 'description': 'Remote ischemic preconditioining', 'interventionNames': ['Procedure: Remote ischemic preconditioning']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Sham preconditioning', 'interventionNames': ['Procedure: Sham preconditioning']}], 'interventions': [{'name': 'Remote ischemic preconditioning', 'type': 'PROCEDURE', 'description': 'Remote ischemic preconditioning through inflation of a blood pressure cuff to pressure values \\> 200mmHg for 5 minutes followed by 5 minutes of reperfusion (3 times each) before electrocardioversion Electrical cardioversion for atrial fibrillation (100, 150, 200 Joule)', 'armGroupLabels': ['Remote Ischemic Preconditioning']}, {'name': 'Sham preconditioning', 'type': 'PROCEDURE', 'description': 'Inflation of a blood pressure cuff to pressure values \\~ 10mmHg for 5 minutes followed by 5 minutes of reperfusion (3 times each) before electrocardioversion', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65189', 'city': 'Wiesbaden', 'state': 'Hesse', 'country': 'Germany', 'facility': 'St. Josefs-Hospital Wiesbaden', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Josefs-Hospital Wiesbaden GmbH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}