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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief 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.


Detailed Summary:
Sponsor: IRCCS Policlinico S. Matteo

Current Primary Outcome: Area Under the Curve of CK - MB release [ Time Frame: baseline to 72h since admission ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: IRCCS Policlinico S. Matteo

Dates:
Date Received: March 18, 2009
Date Started: March 2009
Date Completion:
Last Updated: August 16, 2012
Last Verified: August 2012