NCT02581618

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

9 months

First QC Date

October 19, 2015

Last Update Submit

March 7, 2016

Conditions

Myocardial IschemiaIschemic Reperfusion Injury

Keywords

ischemic preconditioningmyocardial injurypercutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

  • hs-Troponin elevation

    after 16 hours

Study Arms (2)

Study group

EXPERIMENTAL

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.

Other: remote ischemic preconditioning

Control group

NO INTERVENTION

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

Interventions

remote ischemic preconditioningOTHER

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

Study group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University School Of Medicine, Department Of Cardiology

Edirne, 22030, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 25551671RESULT

  • 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.

    PMID: 24163121RESULT

  • 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.

    PMID: 23696599RESULT

  • 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.

    PMID: 24793669RESULT

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Mustafa A YILMAZTEPE, MD

    Trakya University School Of Medicine, Department Of Cardiology, Edirne, TURKEY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Of Medicine

Study Record Dates

First Submitted

October 19, 2015

First Posted

October 21, 2015

Study Start

May 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 8, 2016

Record last verified: 2016-03

Locations

TU(1)