Remote Ischemic Preconditioning in Elective Percutaneous Interventions

NCT ID: NCT02581618

Last Updated: 2016-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myocardial Ischemia Ischemic Reperfusion Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study group

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.

Group Type EXPERIMENTAL

remote ischemic preconditioning

Intervention Type OTHER

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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

remote ischemic preconditioning

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Trakya University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mustafa Adem YILMAZTEPE

Assistant Professor Of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mustafa A YILMAZTEPE, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Trakya University School Of Medicine, Department Of Cardiology

Edirne, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 25551671 (View on PubMed)

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.

Reference Type RESULT
PMID: 24163121 (View on PubMed)

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.

Reference Type RESULT
PMID: 23696599 (View on PubMed)

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.

Reference Type RESULT
PMID: 24793669 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Trakya-Kardiyo-2015-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.