Remote Ischemic Preconditioning in Elective Percutaneous Interventions

Trakya University

Status: Completed

Conditions: Myocardial Ischemia; Ischemic Reperfusion Injury

Treatments: Other: remote ischemic preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT02581618

Trakya-Kardiyo-2015-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Patients with stable coronary artery disease, in whom percutaneous coronary intervention is planned after coronary angiography
• Patients with informed consent

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 2 patient groups

Study group

Experimental group

Description:

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.

Treatment:

Other: remote ischemic preconditioning

Control group

No Intervention group

Description:

No intervention will be performed. Percutaneous coronary intervention will be performed without ischemic preconditioning.