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

NCT ID: NCT00865722

Last Updated: 2012-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2012-05-31

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.

Conditions

Myocardial Reperfusion Injury; Myocardial Ischemia; Myocardial Infarction

Keywords

Remote Postconditioning; Myocardial reperfusion Injury; Myocardial Infarction; Primary PCI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Remote Postconditioning

Intervention Type: PROCEDURE

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

Controls

pPCI and treatments according to guidelines for STEMI

Group Type: SHAM_COMPARATOR

Remote Postconditioning

Intervention Type: PROCEDURE

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

Interventions

Remote Postconditioning

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Maurizio Ferrario

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maurizio Ferrario, MD

Role: STUDY_DIRECTOR

IRCCS Policlinico San Matteo

Gabriele Crimi, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Policlinico San Matteo

Locations

IRCCS Policlinico San Matteo

Pavia, Italy, Italy

ASL3 Genovese, Villa Scassi Hospitale

Genoa, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 24156966 (View on PubMed)

Other Identifiers

RemPostConditioning

Identifier Type: -

Identifier Source: org_study_id