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

IRCCS Policlinico S. Matteo

Status and phase: Completed; Phase 3; Phase 2

Conditions: Myocardial Ischemia; Myocardial Reperfusion Injury; Myocardial Infarction

Treatments: Procedure: Remote Postconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT00865722

RemPostConditioning

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups

RemotePostConditioning

Active Comparator group

Description:

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

Treatment:

Procedure: Remote Postconditioning

Controls

Sham Comparator group

Description:

pPCI and treatments according to guidelines for STEMI

Treatment:

Procedure: Remote Postconditioning