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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RemotePostConditioning | Active Comparator | 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 |
|
| Controls | Sham Comparator | pPCI and treatments according to guidelines for STEMI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Postconditioning | Procedure | Lower limb compression using a cuff inflated to 200 mmHg for 5 ' followed by 5' of reperfusion fo three times during 30' |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve of CK - MB release | baseline to 72h since admission |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve of CK release | baselinte to 72h since admission | |
| TIMI Frame Count | 30 minutes after first balloon inflation in infarct-related artery | |
| Time to balloon |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maurizio Ferrario, MD | IRCCS Policlinico San Matteo | Study Director |
| Gabriele Crimi, MD | IRCCS Policlinico San Matteo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Policlinico San Matteo | Pavia | Italy | 27100 | Italy | ||
| ASL3 Genovese, Villa Scassi Hospitale |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24156966 | Derived | 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. |
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| 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 |
| Mortality rate | 4 months 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 |
| Genoa |
| 16100 |
| Italy |
| ID | Term |
|---|---|
| D015428 | Myocardial Reperfusion Injury |
| D017202 | Myocardial Ischemia |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D015427 | Reperfusion Injury |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |
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