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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00865722
Other study ID # RemPostConditioning
Secondary ID
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


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
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