Remote Ischemic Preconditioning in Elective Percutaneous Interventions

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.

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Key information

Conditions

Myocardial Ischemia Cardiovascular Diseases Heart Diseases Ischemic Reperfusion Injury Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trakya University School Of Medicine, Department Of Cardiology

Edirne, 22030, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote Ischemic Preconditioning

Other

Blood pressure cuff inflation up to 200mmHg in the non-dominant arm before guiding catheter engagement

Primary outcomes

hs-Troponin elevation

Time frame: after 16 hours

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

Effect of One Cycle Remote Ischemic Preconditioning on Myocardial Injury After Percutaneous Coronary Interventions in Patients With Stable Coronary Artery Disease

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Oct 21, 2015
Registry last updated: Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed