Myocardial Infarction, Myocardial Ischemia, Myocardial Reperfusion Injury
Conditions
Keywords
Remote Postconditioning, Myocardial reperfusion Injury, Myocardial Infarction, Primary PCI
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.
Interventions
PROCEDURERemote Postconditioning
Lower limb compression using a cuff inflated to 200 mmHg for 5 ' followed by 5' of reperfusion fo three times during 30'
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Curve of CK - MB release | baseline to 72h since admission |
Secondary
| Measure | Time frame |
|---|---|
| TIMI Frame Count | 30 minutes after first balloon inflation in infarct-related artery |
| Time to balloon | during pPCI |
| Ejection Fraction MRI | before discharge and after 4 months |
| Myocardial Blush grading | 30 minutes after first balloon inflation |
| ST segment resolution | 6h after balloon |
| Troponin I peak | 72h since admission |
| Area Under the Curve of CK release | baselinte to 72h since admission |
| artero-venous differences in pO2, pCO2, pH, HCo3 | baseline and 30 minutes after first balloon inflation |
| Major adverse cardiac events | 4 months since admission |
| artero-venous quantitative and qualitative differences in endothelial progenitors cells (subgroups) | within 24 h since admission |
| artero-venous Differences of Cytokines | within 24h since admission |
| Edema Volume T2 sequences MRI | before discharge |
| Delay enhancement volume MRI | before discharge and after 4 months |
| Mortality rate | 4 months since admission |
Countries
Italy
Outcome results
None listed