Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-02-26 @ 6:18 PM
Study NCT ID:
NCT02581618
Status:
COMPLETED
Last Update Posted:
2016-03-08
First Post:
2015-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remote Ischemic Preconditioning in Elective Percutaneous Interventions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-07', 'studyFirstSubmitDate': '2015-10-19', 'studyFirstSubmitQcDate': '2015-10-20', 'lastUpdatePostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hs-Troponin elevation', 'timeFrame': 'after 16 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ischemic preconditioning', 'myocardial injury', 'percutaneous coronary intervention'], 'conditions': ['Myocardial Ischemia', 'Ischemic Reperfusion Injury']}, 'referencesModule': {'references': [{'pmid': '25551671', 'type': 'RESULT', 'citation': 'Pei H, Wu Y, Wei Y, Yang Y, Teng S, Zhang H. Remote ischemic preconditioning reduces perioperative cardiac and renal events in patients undergoing elective coronary intervention: a meta-analysis of 11 randomized trials. PLoS One. 2014 Dec 31;9(12):e115500. doi: 10.1371/journal.pone.0115500. eCollection 2014.'}, {'pmid': '24163121', 'type': 'RESULT', 'citation': 'Xu X, Zhou Y, Luo S, Zhang W, Zhao Y, Yu M, Ma Q, Gao F, Shen H, Zhang J. Effect of remote ischemic preconditioning in the elderly patients with coronary artery disease with diabetes mellitus undergoing elective drug-eluting stent implantation. Angiology. 2014 Sep;65(8):660-6. doi: 10.1177/0003319713507332. Epub 2013 Oct 24.'}, {'pmid': '23696599', 'type': 'RESULT', 'citation': 'Davies WR, Brown AJ, Watson W, McCormick LM, West NE, Dutka DP, Hoole SP. Remote ischemic preconditioning improves outcome at 6 years after elective percutaneous coronary intervention: the CRISP stent trial long-term follow-up. Circ Cardiovasc Interv. 2013 Jun;6(3):246-51. doi: 10.1161/CIRCINTERVENTIONS.112.000184. Epub 2013 May 21.'}, {'pmid': '24793669', 'type': 'RESULT', 'citation': 'Zografos TA, Katritsis GD, Tsiafoutis I, Bourboulis N, Katsivas A, Katritsis DG. Effect of one-cycle remote ischemic preconditioning to reduce myocardial injury during percutaneous coronary intervention. Am J Cardiol. 2014 Jun 15;113(12):2013-7. doi: 10.1016/j.amjcard.2014.03.043. Epub 2014 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'Myocardial injury occurs after percutaneous coronary intervention due to micro emboli, ischemia-reperfusion injury or side branch occlusion. 3 cycles of ischemic preconditioning has been shown to be useful in preventing myocardial injury but it is not suitable to perform it especially in ad hoc interventions. In this study the investigators aim is to show whether one cycle remote ischemic preconditioning will be enough to prevent myocardial injury during percutaneous coronary intervention.', 'detailedDescription': "About in one third of elective percutaneous coronary interventions (PCI) troponin release occurs showing myocardial necrosis. And it has been shown that myocardial necrosis due to coronary interventions has also adverse effects on long term prognosis.\n\nBeneficial effects of of ischemic preconditioning in elective PCI and in coronary artery bypass surgery has been shown in several studies. In most of the trials 3 cycles of ischemia was performed, but this is time consuming and it's not suitable to apply it, in ad-hoc interventions. The investigators found one study showing that one cycle will also be enough to prevent troponin elevation after elective PCI.\n\nThe investigators aim was also to show that one cycle preconditioning performed just before coronary intervention will also be useful in preventing myocardial necrosis due to elective PCI."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Patients with stable coronary artery disease, in whom percutaneous coronary intervention is planned after coronary angiography\n* Patients with informed consent\n\nExclusion Criteria:\n\n* Acute or chronic renal failure (Creatinin clearance \\<60ml/dk)\n* Acute heart failure\n* Presence of hemodynamic instability\n* Left main interventions\n* Acute Coronary Syndrome\n* Patients in whom cuff inflation is contraindicated in upper extremities (fistula, lymphoedema etc)\n* Patients using nicorandil, glibenclamide or trimetazidine\n* Patients not accepting the study\n* Presence of troponin elevation before intervention\n* Presence or suspicion of pregnancy'}, 'identificationModule': {'nctId': 'NCT02581618', 'briefTitle': 'Remote Ischemic Preconditioning in Elective Percutaneous Interventions', 'organization': {'class': 'OTHER', 'fullName': 'Trakya University'}, 'officialTitle': 'Effect of One Cycle Remote Ischemic Preconditioning on Myocardial Injury After Percutaneous Coronary Interventions in Patients With Stable Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'Trakya-Kardiyo-2015-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Remote ischemic preconditioning arm\n\nBlood pressure cuff will be inflated up to 200 mmHg in the non-dominant arm for 5 minutes before guiding catheter engagement.', 'interventionNames': ['Other: remote ischemic preconditioning']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No intervention will be performed. Percutaneous coronary intervention will be performed without ischemic preconditioning.'}], 'interventions': [{'name': 'remote ischemic preconditioning', 'type': 'OTHER', 'description': 'Blood pressure cuff inflation up to 200mmHg in the non-dominant arm before guiding catheter engagement', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22030', 'city': 'Edirne', 'country': 'Turkey (Türkiye)', 'facility': 'Trakya University School Of Medicine, Department Of Cardiology', 'geoPoint': {'lat': 41.67719, 'lon': 26.55597}}], 'overallOfficials': [{'name': 'Mustafa A YILMAZTEPE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Trakya University School Of Medicine, Department Of Cardiology, Edirne, TURKEY'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trakya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor Of Medicine', 'investigatorFullName': 'Mustafa Adem YILMAZTEPE', 'investigatorAffiliation': 'Trakya University'}}}}