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

Last updated: August 16, 2012
Sponsor: IRCCS Policlinico S. Matteo
Overall Status: Completed

Phase

2/3

Condition

Coronary Artery Disease

Circulation Disorders

Angina

Treatment

N/A

Clinical Study ID

NCT00865722
RemPostConditioning
  • Ages 18-80
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >= 18 yrs AND Age =< 80 yrs

  • STEMI definition

  • Pain to door time < 6 hrs

  • Killip class 1 - 2 - 3

  • Initial TIMI flow 0 - 1 in the anterior descending artery

  • Signed informed consent

Exclusion

Exclusion Criteria:

  • Pregnancy

  • Cardiogenic shock

  • Initial TIMI flow 2 - 3 in the anterior descending artery

  • History of prior MI in the past 6 months

  • History of prior CABG

  • History of peripheral vascular disease III - IV grade

  • History of abdominal Aortic Aneurysm > 5 cm

  • Severe coronaropathy that could condition further revascularization before the end ofthe study

  • Other relevant medical or surgical conditions that can influence prognosis at 4 months

Study Design

Total Participants: 96
Study Start date:
March 01, 2009
Estimated Completion Date:
May 31, 2012

Connect with a study center

  • ASL3 Genovese, Villa Scassi Hospitale

    Genoa, 16100
    Italy

    Site Not Available

  • IRCCS Policlinico San Matteo

    Pavia, 27100
    Italy

    Site Not Available

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