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Remote Ischemic Preconditioning in Elective Percutaneous Interventions

Primary Purpose

Myocardial Ischemia, Ischemic Reperfusion Injury

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
remote ischemic preconditioning
Sponsored by
Trakya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Ischemia focused on measuring ischemic preconditioning, myocardial injury, percutaneous coronary intervention

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Trakya University School Of Medicine, Department Of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study group

Control group

Arm 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.

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

Outcomes

Primary Outcome Measures

hs-Troponin elevation

Secondary Outcome Measures

Full Information

First Posted
October 19, 2015
Last Updated
March 7, 2016
Sponsor
Trakya University
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1. Study Identification

Unique Protocol Identification Number
NCT02581618
Brief Title
Remote Ischemic Preconditioning in Elective Percutaneous Interventions
Official Title
Effect of One Cycle Remote Ischemic Preconditioning on Myocardial Injury After Percutaneous Coronary Interventions in Patients With Stable Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Trakya University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia, Ischemic Reperfusion Injury
Keywords
ischemic preconditioning, myocardial injury, percutaneous coronary intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention will be performed. Percutaneous coronary intervention will be performed without ischemic preconditioning.
Intervention Type
Other
Intervention Name(s)
remote ischemic preconditioning
Intervention Description
Blood pressure cuff inflation up to 200mmHg in the non-dominant arm before guiding catheter engagement
Primary Outcome Measure Information:
Title
hs-Troponin elevation
Time Frame
after 16 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa A YILMAZTEPE, MD
Organizational Affiliation
Trakya University School Of Medicine, Department Of Cardiology, Edirne, TURKEY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Trakya University School Of Medicine, Department Of Cardiology
City
Edirne
ZIP/Postal Code
22030
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
25551671
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. doi: 10.1371/journal.pone.0115500. eCollection 2014.
Results Reference
result
PubMed Identifier
24163121
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. 2014 Sep;65(8):660-6. doi: 10.1177/0003319713507332. Epub 2013 Oct 24.
Results Reference
result
PubMed Identifier
23696599
Citation
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.
Results Reference
result
PubMed Identifier
24793669
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: 10.1016/j.amjcard.2014.03.043. Epub 2014 Apr 1.
Results Reference
result

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Remote Ischemic Preconditioning in Elective Percutaneous Interventions

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