Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-01-29 @ 3:27 AM
Study NCT ID:
NCT01740102
Status:
COMPLETED
Last Update Posted:
2016-08-04
First Post:
2012-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Value of Remote Ischemic Preconditioning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019194', 'term': 'Ischemic Preconditioning'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-03', 'studyFirstSubmitDate': '2012-11-21', 'studyFirstSubmitQcDate': '2012-12-03', 'lastUpdatePostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative atrial fibrillation', 'timeFrame': 'Up to 10 days after surgery', 'description': 'A patient will be classified as belonging to the postoperative atrial fibrillation group if they have any episode of atrial fibrillation, measured by telemetry, lasting more than 1 minute during their postoperative days at the hospital.'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'Maximum 14 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ischemic preconditioning', 'Coronary artery bypass', 'Preoperative care', 'Postoperative period'], 'conditions': ['Heart Diseases', 'Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '25613907', 'type': 'RESULT', 'citation': 'Krogstad LE, Slagsvold KH, Wahba A. Remote ischemic preconditioning and incidence of postoperative atrial fibrillation. Scand Cardiovasc J. 2015 Jun;49(3):117-22. doi: 10.3109/14017431.2015.1010565. Epub 2015 Feb 24.'}]}, 'descriptionModule': {'briefSummary': 'Objectives: Despite utilization of available means for cardioprotection during cardiac surgery, myocardial injury still occurs. Further improvement of cardioprotection is therefore necessary. Remote ischemic preconditioning (RIPC) is an easy and non-invasive method. Laboratory research has shown promising results regarding myocardial survival during open heart surgery, but the clinical value of RIPC is still largely unknown. The investigators hypothesize that RIPC before coronary artery bypass grafting (CABG) reduces the incidence of postoperative atrial fibrillation (POAF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective isolated on-pump CABG surgery\n* Informed consent\n\nExclusion Criteria:\n\n* Patients with a severe pulmonary disease\n* Patients with renal failure (GFR\\<30 mL/min/1.73 m2)\n* Patients with liver failure\n* Peripheral vascular disease affecting the upper limbs\n* Patients on sulfonylurea derivatives.\n* Patients with atrial fibrillation in their case history\n* Prior cardiac surgery (Re-operations)'}, 'identificationModule': {'nctId': 'NCT01740102', 'briefTitle': 'Clinical Value of Remote Ischemic Preconditioning', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Does Remote Ischemic Preconditioning Reduce the Incidence of Postoperative Atrial Fibrillation in Patient Undergoing Coronary Artery Bypass Graft Surgery?', 'orgStudyIdInfo': {'id': '2011/2525'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RIPC', 'description': 'Remote ischemic preconditioning (RIPC) in the operating theatre after induction of anaesthesia and before surgery.', 'interventionNames': ['Procedure: RIPC']}, {'type': 'NO_INTERVENTION', 'label': 'No RIPC', 'description': 'Patients in the control group will not receive remote ischemic preconditioning before the surgery.'}], 'interventions': [{'name': 'RIPC', 'type': 'PROCEDURE', 'otherNames': ['Remote ischemic preconditioning', 'Ischemic preconditioning'], 'description': 'The remote ischemic preconditioning will consist of three sequential sphygmomanometer cuff inflations. The cuff will be inflated up to 200 mmHg for 5 minutes and then deflated for 5 minutes. This cycle will be performed three times in total. The entire preconditioning will therefore last for 25 minutes.', 'armGroupLabels': ['RIPC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olavs Hospital Trondheim University Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Alexander Wahba, MD prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine Norwegian University of Science and Technology Trondheim, Norway, and Department of Cardiothoracic Surgery, St. Olavs Hospital, Trondheim, Norway.'}, {'name': 'Lars Erik B Krogstad', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine Norwegian University of Science and Technology Trondheim, Norway.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helse Nord-Trøndelag HF', 'class': 'OTHER'}, {'name': 'Namsos Hospital', 'class': 'OTHER'}, {'name': 'Sykehuset Innlandet HF', 'class': 'OTHER'}, {'name': 'Helse Møre og Romsdal HF', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}