Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06567249
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-18
Brief Title:
Intracoronary Hypothermia as a Prevention of Reperfusion Injury in Myocardial Infarction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Selective Intracoronary Hypothermia as a Prevention of Reperfusion Injury in ST-elevation Myocardial Infarction
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acute myocardial infarction with ST segment elevation is often accompanied by a totally occluded coronary artery Which has deleterious effects on heart muscle Primary percutaneous coronary intervention is the most effective mode of treatment for ST-elevation myocardial infarction STEMI patients Despite the restoration of the blood flow 30-60 of patients develop microvascular obstruction which lowers the effects of the coronary blood flow restoration The most advanced coronary microvascular obstruction presents as a no-reflow phenomenon which is an abrupt deceleration or absence of coronary flow following stent implantation Several pharmacological treatments have been proposed as well as deferred stenting but none of them really helped Thus new ways of alleviating coronary obstruction are warranted One of the new ways of mitigating the reperfusion injury is intracoronary hypothermia which showed to be safe on a handful of patients in small series In the animal studies intracoronary hypothermia demonstrated a protective effect in terms of reducing infarct area But clinical studies failed to reproduce the protective effects of intracoronary hypothermia Thus our study using a modified hypothermia protocol will test the hypothermia hypothesis
Detailed Description:
The study aims to find the most effective methods for the prevention and treatment of microvascular obstruction and reperfusion injury studying the pathophysiological mechanisms of the development of this complication is of key importance Many of these mechanisms are now known In particular the risk of developing microvascular obstruction is directly proportional to the duration of coronary artery occlusion the degree of platelet aggregation activity and blood viscosity and is higher in patients with massive thrombosis of the ischemic artery during percutaneous coronary intervention which suggests a significant contribution to the development of microembolization during mechanical thrombus fragmentation Despite all the collected data there is no effective mode of reperfusion injury prophylaxis Thus it is necessary to explore new ways of minimizing reperfusion injury during primary percutaneous coronary intervention The goal of our study is to determine the safety and effectiveness of intracoronary hypothermia All patients who meet the eligibility criteria for this study will be randomized in a 11 ratio to receive intracoronary hypothermia with subsequent percutaneous coronary intervention or a standard revascularization strategy The total number of patients planned to be recruited is 60 The study was approved by the local ethics committee The intracoronary hypothermia group will receive 4C normal saline with an infusion rate of 5 mlmin for 5 minutes through the inflated over-the-wire balloon followed by an infusion of 4C normal saline for 15 minutes with the same infusion rate of 5 ml per minute through the deflated over-the-wire balloon After that standard percutaneous coronary intervention is performed The control group will receive only the standard percutaneous coronary intervention procedure
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