Remote Ischemic Preconditioning in Elective Percutaneous Interventions
NCT ID: NCT02581618
Last Updated: 2016-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
102 participants
INTERVENTIONAL
2015-05-31
2016-02-29
Brief Summary
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Detailed Description
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Beneficial 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.
The 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Study group
Remote ischemic preconditioning arm
Blood pressure cuff will be inflated up to 200 mmHg in the non-dominant arm for 5 minutes before guiding catheter engagement.
remote ischemic preconditioning
Blood pressure cuff inflation up to 200mmHg in the non-dominant arm before guiding catheter engagement
Control group
No intervention will be performed. Percutaneous coronary intervention will be performed without ischemic preconditioning.
No interventions assigned to this group
Interventions
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remote ischemic preconditioning
Blood pressure cuff inflation up to 200mmHg in the non-dominant arm before guiding catheter engagement
Eligibility Criteria
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Inclusion Criteria
* Patients with informed consent
Exclusion Criteria
* Acute heart failure
* Presence of hemodynamic instability
* Left main interventions
* Acute Coronary Syndrome
* Patients in whom cuff inflation is contraindicated in upper extremities (fistula, lymphoedema etc)
* Patients using nicorandil, glibenclamide or trimetazidine
* Patients not accepting the study
* Presence of troponin elevation before intervention
* Presence or suspicion of pregnancy
18 Years
80 Years
ALL
No
Sponsors
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Trakya University
OTHER
Responsible Party
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Mustafa Adem YILMAZTEPE
Assistant Professor Of Medicine
Principal Investigators
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Mustafa A YILMAZTEPE, MD
Role: PRINCIPAL_INVESTIGATOR
Trakya University School Of Medicine, Department Of Cardiology, Edirne, TURKEY
Locations
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Trakya University School Of Medicine, Department Of Cardiology
Edirne, , Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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Trakya-Kardiyo-2015-1
Identifier Type: -
Identifier Source: org_study_id
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