N/A N=266 Randomized Single-blind

Remote Ischemic Postconditioning in Humans

Myocardial Reperfusion Injury

Bottom Line

View on ClinicalTrials.gov: NCT01113008 ↗

Enrolled (actual)

266

Serious AEs

0.8%

Results posted

Jan 2015

Primary outcome: Primary: Maximum Increase of Troponin at 24 Hours — 0.478; 0.476 ng/ml

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Remote ischemic postconditioning (Procedure); Control group (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hospital Universitario Virgen de la Victoria
Primary completion: Feb 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Increase of Troponin at 24 Hours	0.478; 0.476	—
SECONDARY Readmission Due to Acute Coronary Syndrome	1; 4	—
SECONDARY Cardiovascular Mortality	0; 2	—

Summary

The aim of this study is to evaluate the phenomenon of remote ischemic post-conditioning in humans. The minor myocardial damage associated with percutaneous revascularization procedures may be attenuated by producing controlled ischemia in the arms immediately after carrying out these procedures (remote ischemic post-conditioning). The justification and design of this clinical trial has been reported: Cardiology. 2011;119(3):164-9.

Eligibility Criteria

Inclusion Criteria

Patients undergoing PCI due to stable angina
Patients undergoing PCI due to unstable angina
Patients undergoing PCI due NON Q acute myocardial infarction with normal troponin at inclusion moment (less than 1 ng/ml)

Exclusion Criteria

Acute myocardial infarction during the previous two weeks
Chronic renal failure with baseline creatinine above 3 mg/dL
Collateral circulation of the revascularized artery (Rantrop >0) 5. Prior treatment with glibenclamide. 6. Inability to receive follow-up, blood test or lack of informed consent.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01113008). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.