Clinical trial NCT00865722: Remote Postconditioning in Patients With Acute Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention (PCI)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Myocardial Reperfusion Injury
Myocardial Ischemia
Myocardial Infarction
Keywords: Remote Postconditioning
Myocardial reperfusion Injury
Myocardial Infarction
Primary PCI
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2009-03-19
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Area Under the Curve of CK - MB release
timeFrame: baseline to 72h since admission
Secondary outcomes:
measure: Area Under the Curve of CK release
timeFrame: baselinte to 72h since admission
measure: TIMI Frame Count
timeFrame: 30 minutes after first balloon inflation in infarct-related artery
measure: Time to balloon
timeFrame: during pPCI
measure: Ejection Fraction MRI
timeFrame: before discharge and after 4 months
measure: Myocardial Blush grading
timeFrame: 30 minutes after first balloon inflation
measure: ST segment resolution
timeFrame: 6h after balloon
measure: Troponin I peak
timeFrame: 72h since admission
measure: Mortality rate
timeFrame: 4 months since admission
measure: artero-venous differences in pO2, pCO2, pH, HCo3
timeFrame: baseline and 30 minutes after first balloon inflation
measure: Major adverse cardiac events
timeFrame: 4 months since admission
measure: artero-venous quantitative and qualitative differences in endothelial progenitors cells (subgroups)
timeFrame: within 24 h since admission
measure: artero-venous Differences of Cytokines
timeFrame: within 24h since admission
measure: Edema Volume T2 sequences MRI
timeFrame: before discharge
measure: Delay enhancement volume MRI
timeFrame: before discharge and after 4 months
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: ASL3 Genovese, Villa Scassi Hospitale
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
Study officials:
affiliation: IRCCS Policlinico San Matteo
name: Maurizio Ferrario, MD
role: STUDY_DIRECTOR
affiliation: IRCCS Policlinico San Matteo
name: Gabriele Crimi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.