Ignite Creation Date:
2024-05-05 @ 11:03 PM
Last Modification Date:
2024-10-26 @ 10:28 AM
Study NCT ID:
NCT01245855
Status:
UNKNOWN
Last Update Posted:
2010-11-23
First Post:
2010-11-22
Brief Title:
Protective Effect of Lipo-PGE1 on Myocardial Injury Following Percutaneous Coronary Intervention
Sponsor:
First Affiliated Hospital Sun Yat-Sen University
Organization:
First Affiliated Hospital Sun Yat-Sen University
Study Overview
Official Title:
Protective Effect of Lipo-PGE1 on Myocardial Injury Following Percutaneous Coronary Intervention
Status:
UNKNOWN
Status Verified Date:
2010-10
Last Known Status:
NOT_YET_RECRUITING
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:
PGEACS
Brief Summary:
we hypothesized that periprocedural treatment with intravenous lipo-PGE1 may reduce myocardial injury and improve clinical outcomes in patients undergoing PCI
Detailed Description:
Ever since the inception of percutaneous coronary intervention PCI it has been apparent that some myocardial injury was often associated with the procedure and even asymptomatic minor post-procedural myocardial necrosis does have an important prognostic signification The possible mechanisms of periprocedural myocardial injury were often attributed to distal embolisation of atheromatous material during the procedure occlusion of minute side branches occlusive dissection or no-reflow
Prostaglandin E1 incorporated in lipid microspheres lipo-PGE1 is a new galenic form of PGE1 with PGE1 incorporated into soybean oil microspheres 02 micron in diameter using lecithin as surfactant This drug preparation can protect PGE1 against inactivation in the lung and has targeting effect to tissues injured by arterial occlusion It was shown in the experiments that by the pharmacological effects such as improving endothelial function dilating coronary and systemic microvessels inhibiting platelet aggregation and reducing ischemia-reperfusion injury lipo-PGE1 had a more marked protective effect in arterial occlusive tissue injury and a more potent platelet aggregation inhibitory effect than free PGE1 Clinical studies have demonstrated that lipo-PGE1 is a very valuable agent for the treatment of peripheral vascular disorders and diabetic neuropathy
Prostaglandin E1 incorporated in lipid microspheres lipo-PGE1 is a new galenic form of PGE1 with PGE1 incorporated into soybean oil microspheres 02 micron in diameter using lecithin as surfactant This drug preparation can protect PGE1 against inactivation in the lung and has targeting effect to tissues injured by arterial occlusion It was shown in the experiments that by the pharmacological effects such as improving endothelial function dilating coronary and systemic microvessels inhibiting platelet aggregation and reducing ischemia-reperfusion injury lipo-PGE1 had a more marked protective effect in arterial occlusive tissue injury and a more potent platelet aggregation inhibitory effect than free PGE1 Clinical studies have demonstrated that lipo-PGE1 is a very valuable agent for the treatment of peripheral vascular disorders and diabetic neuropathy
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