MedTrace Logo

Remote Postconditioning in Patients With Acute Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention (PCI)

NCT00865722 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2012-08-17

No results posted yet for this study

Summary

Background: Experimental studies suggest that remote limb ischaemic postconditioning (RemPostCon) can reduce infarct size in pigs. Initial clinical applications support the beneficial role of RemPostCon in preserving endothelial function during upper limb ischemia in healthy volunteers and in patients with stable coronary artery disease.

Aim of the study: To evaluate the feasibility, safety and efficacy of RemPostCon in the setting of STEMI and primary PCI (pPCI) and to investigate potential circulating mediators of its effects.

Patients and methods: Patients who undergo pPCI for anterior STEMI within 6 hours since the onset of symptoms are randomly assigned to receive either RemPostCon + pPCI or pPCI alone in a single-blind fashion. All patients receive therapy according to the current international guidelines. Three cycles of ischemia-reperfusion are provided to the lower limb inflating a cuff to 200 mmHg. Each cycle consists of 5' of ischaemia, followed by 5' of reperfusion. RemPostCon is started at the time of angioplasty in the infarct related artery. Primary endpoint is the area under the curve (AUC) of creatinine kinase - MB (CK - MB). Cardiac magnetic resonance (CMR) is performed early before discharge and 4 months after the event, if there are no contraindications.

Conditions

Interventions

PROCEDURE

Remote Postconditioning

Lower limb compression using a cuff inflated to 200 mmHg for 5 ' followed by 5' of reperfusion fo three times during 30'

Sponsors & Collaborators

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    lead OTHER

Principal Investigators

  • Maurizio Ferrario, MD · IRCCS Policlinico San Matteo

  • Gabriele Crimi, MD · IRCCS Policlinico San Matteo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00865722 on ClinicalTrials.gov