Ignite Creation Date:
2024-05-05 @ 9:20 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00865722
Status:
COMPLETED
Last Update Posted:
2012-08-17
First Post:
2009-03-18
Brief Title:
Remote Postconditioning in Patients With Acute Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention PCI
Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Organization:
Fondazione IRCCS Policlinico San Matteo di Pavia
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RemPostCon
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None