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

Overview

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.

Full Title of Study: “Pilot Study to Test Feasibility, Safety, Molecular Mediators and Preliminary Efficacy of Remote Myocardial Postconditioning Provided With Extrinsic Cuff Compression of Lower Limb During Primary PCI”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: May 2012

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’

Arms, Groups and Cohorts

  • Active Comparator: RemotePostConditioning
    • Patients will receive pPCI and treatments according to guidelines for STEMI PLUS extrinsic cuff compression to the lower limb for 5 ‘ followed by 5′ reperfusion for three cycles (30’ in total) starting with myocardial reperfusion
  • Sham Comparator: Controls
    • pPCI and treatments according to guidelines for STEMI

Clinical Trial Outcome Measures

Primary Measures

  • Area Under the Curve of CK – MB release
    • Time Frame: baseline to 72h since admission

Secondary Measures

  • Area Under the Curve of CK release
    • Time Frame: baselinte to 72h since admission
  • TIMI Frame Count
    • Time Frame: 30 minutes after first balloon inflation in infarct-related artery
  • Time to balloon
    • Time Frame: during pPCI
  • Ejection Fraction MRI
    • Time Frame: before discharge and after 4 months
  • Myocardial Blush grading
    • Time Frame: 30 minutes after first balloon inflation
  • ST segment resolution
    • Time Frame: 6h after balloon
  • Troponin I peak
    • Time Frame: 72h since admission
  • Mortality rate
    • Time Frame: 4 months since admission
  • artero-venous differences in pO2, pCO2, pH, HCo3
    • Time Frame: baseline and 30 minutes after first balloon inflation
  • Major adverse cardiac events
    • Time Frame: 4 months since admission
  • artero-venous quantitative and qualitative differences in endothelial progenitors cells (subgroups)
    • Time Frame: within 24 h since admission
  • artero-venous Differences of Cytokines
    • Time Frame: within 24h since admission
  • Edema Volume T2 sequences MRI
    • Time Frame: before discharge
  • Delay enhancement volume MRI
    • Time Frame: before discharge and after 4 months

Participating in This Clinical Trial

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 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 of the study – Other relevant medical or surgical conditions that can influence prognosis at 4 months

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • IRCCS Policlinico S. Matteo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Maurizio Ferrario, MD – IRCCS Policlinico S. Matteo
  • Overall Official(s)
    • Maurizio Ferrario, MD, Study Director, IRCCS Policlinico San Matteo
    • Gabriele Crimi, MD, Principal Investigator, IRCCS Policlinico San Matteo

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