Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-02-04 @ 12:23 PM
Study NCT ID:
NCT01906918
Status:
UNKNOWN
Last Update Posted:
2013-11-28
First Post:
2013-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Remote Ischemic Preconditioning in Patients Undergoing Open Heart Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular 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', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-27', 'studyFirstSubmitDate': '2013-07-21', 'studyFirstSubmitQcDate': '2013-07-21', 'lastUpdatePostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Molecular pathway activation', 'timeFrame': '2 days'}, {'measure': 'Inflammatory response', 'timeFrame': '10 days'}], 'secondaryOutcomes': [{'measure': 'All cause of mortality', 'timeFrame': '30 days'}, {'measure': 'All cause of mortality', 'timeFrame': '180 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ischemia', 'reperfusion', 'myocardial ischemia', 'myocardial reperfusion'], 'conditions': ['Coronary Artery Disease', 'Valvular Heart Disease']}, 'descriptionModule': {'briefSummary': 'Strategies for myocardial protection during open heart surgeries are desired. Several experimental studies have shown beneficial effects of remote ischemic preconditioning (RIPC). The underlying mechanisms are not totally understood. This study intends to evaluate molecular mechanisms involved with RIPC on myocardium of patients underwent open heart surgeries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years\n* Scheduled for coronary artery bypass grafting with or without valve replacement associated\n* Use of blood cardioplegia\n* EuroSCORE II greater than or equal to 1.0%\n\nExclusion Criteria:\n\n* History of cardiogenic shock\n* Complications in the admission\n* Pregnant patients\n* Severe peripheral arterial disease affecting the upper limbs\n* Liver failure (bilirubin ˃ 20 mmol / L, INR 2.0 ˃)\n* Significant pulmonary disease (˂ FEV1 40%)\n* Renal failure with glomerular filtration rate ˂ ml/min/1,73 m²\n* Concomitant treatment with glibenclamide or nicorandil (medications that interfere with cardioprotection induced by IPCR)'}, 'identificationModule': {'nctId': 'NCT01906918', 'briefTitle': 'Application of Remote Ischemic Preconditioning in Patients Undergoing Open Heart Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'University of Campinas, Brazil'}, 'officialTitle': 'Evaluation of Remote Preconditioning on Heart Resistance to Ischemia and Reperfusion Injury', 'orgStudyIdInfo': {'id': 'RIPC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IRPC, Remote preconditioning', 'description': 'This group will be submitted to ischemic preconditioning', 'interventionNames': ['Procedure: IRPC, Remote preconditioning']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'This patients will be submitted to the standard surgery protocol in the institution. The patients will not be submitted to 5 minutes of upper limb compression by cuff followed by 5 minutes of reperfusion.'}], 'interventions': [{'name': 'IRPC, Remote preconditioning', 'type': 'PROCEDURE', 'description': 'The patients will be submitted to 5 minutes of upper limb compression by cuff followed by 5 minutes of reperfusion. This cycle will be repeated 4 times.', 'armGroupLabels': ['IRPC, Remote preconditioning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13100000', 'city': 'Campinas', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Fany Lima', 'role': 'CONTACT', 'email': 'fanyslima@gmail.com', 'phone': '++55 (19) 3521-7131'}, {'name': 'Orlando Petrucci, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Fany Lima, RN', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pedro Paulo M Oliveira, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lindemberg M Silveira-Filho, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Karlos AS Vilarinho, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elaine S Severino, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Daniela D Carvalho, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital das Clínicas da Unicamp', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}], 'centralContacts': [{'name': 'Orlando Petrucci, MD, PhD', 'role': 'CONTACT', 'email': 'petrucci@cardiol.br', 'phone': '+55 19 97253335'}], 'overallOfficials': [{'name': 'Orlando Petrucci, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Campinas'}, {'name': 'Fany Lima, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Campinas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campinas, Brazil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Phd', 'investigatorFullName': 'Orlando Petrucci', 'investigatorAffiliation': 'University of Campinas, Brazil'}}}}