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

Myocardial Infarction Clinical Trial

— RemPostCon  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00865722
• Other study ID #: RemPostConditioning
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 18, 2009
• Last updated: August 16, 2012
• Start date: March 2009
• Est. completion date: May 2012

Study information

• Verified date: August 2012
• Source: IRCCS Policlinico S. Matteo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• Myocardial Reperfusion Injury
• Reperfusion Injury

Intervention

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'

Locations

Country	Name	City	State
Italy	ASL3 Genovese, Villa Scassi Hospitale	Genoa
Italy	IRCCS Policlinico San Matteo	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve of CK - MB release		baseline to 72h since admission	No
Secondary	Area Under the Curve of CK release		baselinte to 72h since admission	No
Secondary	TIMI Frame Count		30 minutes after first balloon inflation in infarct-related artery	No
Secondary	Time to balloon		during pPCI	Yes
Secondary	Ejection Fraction MRI		before discharge and after 4 months	No
Secondary	Myocardial Blush grading		30 minutes after first balloon inflation	No
Secondary	ST segment resolution		6h after balloon	No
Secondary	Troponin I peak		72h since admission	No
Secondary	Mortality rate		4 months since admission	Yes
Secondary	artero-venous differences in pO2, pCO2, pH, HCo3		baseline and 30 minutes after first balloon inflation	No
Secondary	Major adverse cardiac events		4 months since admission	Yes
Secondary	artero-venous quantitative and qualitative differences in endothelial progenitors cells (subgroups)		within 24 h since admission	No
Secondary	artero-venous Differences of Cytokines		within 24h since admission	No
Secondary	Edema Volume T2 sequences MRI		before discharge	No
Secondary	Delay enhancement volume MRI		before discharge and after 4 months	No