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Completed

NCT Number: NCT00865722

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

IRCCS Policlinico San Matteo, Pavia, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote Postconditioning

Procedure

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

Primary outcomes

  1. Area Under the Curve of CK - MB release

    Time frame: baseline to 72h since admission

Secondary outcomes

  1. Area Under the Curve of CK release

    Time frame: baselinte to 72h since admission

  2. TIMI Frame Count

    Time frame: 30 minutes after first balloon inflation in infarct-related artery

  3. Time to balloon

    Time frame: during pPCI

  4. Ejection Fraction MRI

    Time frame: before discharge and after 4 months

  5. Myocardial Blush grading

    Time frame: 30 minutes after first balloon inflation

  6. ST segment resolution

    Time frame: 6h after balloon

  7. Troponin I peak

    Time frame: 72h since admission

  8. Mortality rate

    Time frame: 4 months since admission

  9. artero-venous differences in pO2, pCO2, pH, HCo3

    Time frame: baseline and 30 minutes after first balloon inflation

  10. Major adverse cardiac events

    Time frame: 4 months since admission

  11. artero-venous quantitative and qualitative differences in endothelial progenitors cells (subgroups)

    Time frame: within 24 h since admission

  12. artero-venous Differences of Cytokines

    Time frame: within 24h since admission

  13. Edema Volume T2 sequences MRI

    Time frame: before discharge

  14. Delay enhancement volume MRI

    Time frame: before discharge and after 4 months

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study 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

Acronym: RemPostCon

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Mar 19, 2009
Registry last updated
Aug 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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