Remote Ischemic Preconditioning in Elective Percutaneous Interventions

Not Applicable

Completed

• Conditions: Ischemic Reperfusion Injury; Myocardial Ischemia
• Interventions: Other: remote ischemic preconditioning

• Registration Number: NCT02581618
• Lead Sponsor: Trakya University

Brief Summary

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.

Detailed Description

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.

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-10-19
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-21
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

• Acute or chronic renal failure (Creatinin clearance <60ml/dk)
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	remote ischemic preconditioning	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.

Primary Outcome Measures

Name	Time	Method
hs-Troponin elevation	after 16 hours

Trial Locations

Locations (1)

Trakya University School Of Medicine, Department Of Cardiology; 🇹🇷 Edirne, Turkey