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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maurizio Ferrario, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier:
NCT00865722
First received: March 18, 2009
Last updated: August 16, 2012
Last verified: August 2012

March 18, 2009
August 16, 2012
March 2009
May 2012   (final data collection date for primary outcome measure)
Area Under the Curve of CK - MB release [ Time Frame: baseline to 72h since admission ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00865722 on ClinicalTrials.gov Archive Site
  • Area Under the Curve of CK release [ Time Frame: baselinte to 72h since admission ] [ Designated as safety issue: No ]
  • TIMI Frame Count [ Time Frame: 30 minutes after first balloon inflation in infarct-related artery ] [ Designated as safety issue: No ]
  • Time to balloon [ Time Frame: during pPCI ] [ Designated as safety issue: Yes ]
  • Ejection Fraction MRI [ Time Frame: before discharge and after 4 months ] [ Designated as safety issue: No ]
  • Myocardial Blush grading [ Time Frame: 30 minutes after first balloon inflation ] [ Designated as safety issue: No ]
  • ST segment resolution [ Time Frame: 6h after balloon ] [ Designated as safety issue: No ]
  • Troponin I peak [ Time Frame: 72h since admission ] [ Designated as safety issue: No ]
  • Mortality rate [ Time Frame: 4 months since admission ] [ Designated as safety issue: Yes ]
  • artero-venous differences in pO2, pCO2, pH, HCo3 [ Time Frame: baseline and 30 minutes after first balloon inflation ] [ Designated as safety issue: No ]
  • Major adverse cardiac events [ Time Frame: 4 months since admission ] [ Designated as safety issue: Yes ]
  • artero-venous quantitative and qualitative differences in endothelial progenitors cells (subgroups) [ Time Frame: within 24 h since admission ] [ Designated as safety issue: No ]
  • artero-venous Differences of Cytokines [ Time Frame: within 24h since admission ] [ Designated as safety issue: No ]
  • Edema Volume T2 sequences MRI [ Time Frame: before discharge ] [ Designated as safety issue: No ]
  • Delay enhancement volume MRI [ Time Frame: before discharge and after 4 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Remote Postconditioning in Patients With Acute Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention (PCI)
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Myocardial Reperfusion Injury
  • Myocardial Ischemia
  • Myocardial Infarction
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'
  • 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
    Intervention: Procedure: Remote Postconditioning
  • Sham Comparator: Controls
    pPCI and treatments according to guidelines for STEMI
    Intervention: Procedure: Remote Postconditioning
Crimi G, Pica S, Raineri C, Bramucci E, De Ferrari GM, Klersy C, Ferlini M, Marinoni B, Repetto A, Romeo M, Rosti V, Massa M, Raisaro A, Leonardi S, Rubartelli P, Oltrona Visconti L, Ferrario M. Remote ischemic post-conditioning of the lower limb during primary percutaneous coronary intervention safely reduces enzymatic infarct size in anterior myocardial infarction: a randomized controlled trial. JACC Cardiovasc Interv. 2013 Oct;6(10):1055-63. doi: 10.1016/j.jcin.2013.05.011.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00865722
RemPostConditioning
No
Maurizio Ferrario, IRCCS Policlinico S. Matteo
IRCCS Policlinico S. Matteo
Not Provided
Study Director: Maurizio Ferrario, MD IRCCS Policlinico San Matteo
Principal Investigator: Gabriele Crimi, MD IRCCS Policlinico San Matteo
IRCCS Policlinico S. Matteo
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP