Remote Ischemic Preconditioning in Elective Percutaneous Interventions

Myocardial Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02581618
• Other study ID #: Trakya-Kardiyo-2015-1
• Status: Completed
• Phase: N/A
• First received: October 19, 2015
• Last updated: March 7, 2016
• Start date: May 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Trakya University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemia
• Ischemic Reperfusion Injury
• Myocardial Ischemia
• Reperfusion Injury

Intervention

Other:
• remote ischemic preconditioning
Blood pressure cuff inflation up to 200mmHg in the non-dominant arm before guiding catheter engagement

Locations

Country	Name	City	State
Turkey	Trakya University School Of Medicine, Department Of Cardiology	Edirne

Sponsors (1)

Lead Sponsor	Collaborator
Trakya University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. 201 — View 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 — View 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. — View 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: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hs-Troponin elevation		after 16 hours	Yes