Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-03-06 @ 7:40 PM
Study NCT ID:
NCT02779660
Status:
UNKNOWN
Last Update Posted:
2017-08-22
First Post:
2016-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Remote Ischemic Preconditioning on Electrophysiological and Biomolecular Parameters in Non-valvular Paroxysmal Atrial Fibrillation: RIPPAF Study
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 146}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-17', 'studyFirstSubmitDate': '2016-05-12', 'studyFirstSubmitQcDate': '2016-05-19', 'lastUpdatePostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'inducibility of Atrial Fibrillation by high-rate pacing of 20 s', 'timeFrame': 'during the Atrial Fibrillation Ablation procedure'}, {'measure': 'sustainability of Atrial Fibrillation measured in seconds', 'timeFrame': 'during the Atrial Fibrillation Ablation procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '31356986', 'type': 'DERIVED', 'citation': 'Kosiuk J, Langenhan K, Stegmann C, Uhe T, Dagres N, Dinov B, Kircher S, Richter S, Sommer P, Bertagnolli L, Bollmann A, Hindricks G. Effect of remote ischemic preconditioning on electrophysiological parameters in nonvalvular paroxysmal atrial fibrillation: The RIPPAF Randomized Clinical Trial. Heart Rhythm. 2020 Jan;17(1):3-9. doi: 10.1016/j.hrthm.2019.07.026. Epub 2019 Jul 26.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to examine the effect of RIPC on physiological parameters in non-valvular paroxysmal atrial fibrillation. Furthermore the study will provide a unique bio-date base for further analysis of molecular and genetic mechanisms responsible for observed results.\n\nThe potential effect of RIPC on AF inducibility and/or prothrombotic activity might be implemented as additional treatment component to reduce AF burden and minimize thromboembolic risk.\n\nInterim Analysis will be done after 73 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* planned invasive Atrial Fibrillation ablation\n\nExclusion Criteria:\n\n* AF in ECG at Admission\n* history of AF ablation\n* age \\<18\n* pregnancy\n* neoplastic disorders\n* acute or systemic inflammation, autoimmune diseases\n* documented atrial flutter'}, 'identificationModule': {'nctId': 'NCT02779660', 'acronym': 'RIPPAF', 'briefTitle': 'Effect of Remote Ischemic Preconditioning on Electrophysiological and Biomolecular Parameters in Non-valvular Paroxysmal Atrial Fibrillation: RIPPAF Study', 'organization': {'class': 'OTHER', 'fullName': 'Heart Center Leipzig - University Hospital'}, 'officialTitle': 'Effect of Remote Ischemic Preconditioning on Electrophysiological and Biomolecular Parameters in Non-valvular Paroxysmal Atrial Fibrillation: RIPPAF Study', 'orgStudyIdInfo': {'id': 'RIPPAF V1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RIPC-Group', 'description': 'After randomization patients will undergo 3 sessions of RIPC (Remote ischemic preconditioning) intervention: I) on preoperative day, II) 1 h before and III) directly before the blood sample collection and invasive measurement of electrophysiological parameters.', 'interventionNames': ['Procedure: Remote ischemic preconditioning (RIPC)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control-Group', 'description': 'After randomization patients will undergo 3 sessions of sham-intervention: I) on preoperative day, II) 1 h before and III) directly before the blood sample collection and invasive measurement of electrophysiological parameters.', 'interventionNames': ['Procedure: sham-intervention']}], 'interventions': [{'name': 'Remote ischemic preconditioning (RIPC)', 'type': 'PROCEDURE', 'description': 'RIPC will be induced by the application of 3 short episodes (5 minutes) of forearm ischemia by cuff sphygmomanometer inflation separated by 5 minutes of reperfusion.', 'armGroupLabels': ['RIPC-Group']}, {'name': 'sham-intervention', 'type': 'PROCEDURE', 'description': 'In the control group the cuff will be inflated for 3 times at 10 mm Hg for 5 minutes with 5-minute intervals', 'armGroupLabels': ['Control-Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04289', 'city': 'Leipzig', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jedrzej Kosiuk', 'role': 'CONTACT', 'email': 'Jedrzej.Kosiuk@helios-kliniken.de'}], 'facility': 'Herzzentrum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'centralContacts': [{'name': 'Jedrzej Kosiuk, MD', 'role': 'CONTACT', 'email': 'Jedrzej.Kosiuk@helios-kliniken.de'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jedrzej Kosiuk', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD Jedrzej Kosiuk', 'investigatorFullName': 'Jedrzej Kosiuk', 'investigatorAffiliation': 'Heart Center Leipzig - University Hospital'}}}}