Remote Postconditioning
ProcedureLower limb compression using a cuff inflated to 200 mmHg for 5 ' followed by 5' of reperfusion fo three times during 30'
NCT Number: NCT00865722
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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Notify Me18 year–80 year
All sexes
Interventional
Phase 2 / Phase 3
IRCCS Policlinico San Matteo, Pavia, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lower limb compression using a cuff inflated to 200 mmHg for 5 ' followed by 5' of reperfusion fo three times during 30'
Time frame: baseline to 72h since admission
Time frame: baselinte to 72h since admission
Time frame: 30 minutes after first balloon inflation in infarct-related artery
Time frame: during pPCI
Time frame: before discharge and after 4 months
Time frame: 30 minutes after first balloon inflation
Time frame: 6h after balloon
Time frame: 72h since admission
Time frame: 4 months since admission
Time frame: baseline and 30 minutes after first balloon inflation
Time frame: 4 months since admission
Time frame: within 24 h since admission
Time frame: within 24h since admission
Time frame: before discharge
Time frame: before discharge and after 4 months
Fondazione IRCCS Policlinico San Matteo di Pavia
Other
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
Acronym: RemPostCon
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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