Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334373
Status:
COMPLETED
Last Update Posted:
2015-05-28
First Post:
2006-06-06
Brief Title:
Post Conditioning in PCI for Acute ST Elevation Myocardial Infarction
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Post Conditioning in PCI for Acute ST Elevation Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2015-05
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:
None
Brief Summary:
The purpose of this trial is to compare post-conditioning to standard angioplasty 5050 chance in patients who present with an acute heart attack and are taken directly for an angioplasty procedure Post conditioning is a procedure that involves balloon inflation followed by deflation in a series of cycles that appears to show based on early data that it can decrease the amount of damage to the heart muscle as compared to standard angioplasty procedures
Hypothesis For Subjects undergoing direct PCI for STEMI post conditioning with cycles of balloon inflationdeflation within the first minute following the re-establishment of coronary blood blow will decrease the amount of irreversible myocardial damage assessed by delayed enhancement contrast CMR
Hypothesis For Subjects undergoing direct PCI for STEMI post conditioning with cycles of balloon inflationdeflation within the first minute following the re-establishment of coronary blood blow will decrease the amount of irreversible myocardial damage assessed by delayed enhancement contrast CMR
Detailed Description:
In patients who suffer a myocardial infarction the blood flow usually ceases due to plaque rupture leading to thrombus formation and vessel occlusion The resultant entity is known as ST Elevation segment myocardial infarction STEMI and is a significant health issue in industrialized countries There are over 50000 STEMIs every year in Canada and up to 10 of these patients die in hospital and another 10 die within the first year after their heart attack The more common problem however is not death but irreparable damage to the left ventricle leading to LV dysfunction and subsequent heart failure and arrythmias Re-establishing blood flow promptly by administering plasminogen activators lytics or mechanically by performing angioplasty is possible and has lowered the mortality rate dramatically
Although reperfusion is necessary it gives rise to an entity known as ischemia-reperfusion where acutely re-establishing blood flow and oxygen levels of the heart has detrimental effects Clinically this is manifested as no-reflow that causes subsequent damage to the left ventricle and decreases the beneficial affect of early reperfusion by PCI The ischemia-reperfusion effect sets off a molecular cascade of events involving unfavorable interaction between neutrophils platelets and endothelium that is fairly well identified Efforts to pharmacologically block this effect have not proven to be particularly effective
Post conditioning follows from a concept of pre-conditioning in animals that showed a decrease in myocardial infarct size Pre-conditioning is not useful as it requires to be performed prior to the development of ischemiainjury Post conditioning in preliminary studies with animals and one small study in humans have shown promising results for decrease in infarct size Post conditioning is a procedure of gradual conditioning in which the artery is opened and closed in cycles with inflationdeflation of the culprit artery followed immediately by standard PCI and placement of stent
Although reperfusion is necessary it gives rise to an entity known as ischemia-reperfusion where acutely re-establishing blood flow and oxygen levels of the heart has detrimental effects Clinically this is manifested as no-reflow that causes subsequent damage to the left ventricle and decreases the beneficial affect of early reperfusion by PCI The ischemia-reperfusion effect sets off a molecular cascade of events involving unfavorable interaction between neutrophils platelets and endothelium that is fairly well identified Efforts to pharmacologically block this effect have not proven to be particularly effective
Post conditioning follows from a concept of pre-conditioning in animals that showed a decrease in myocardial infarct size Pre-conditioning is not useful as it requires to be performed prior to the development of ischemiainjury Post conditioning in preliminary studies with animals and one small study in humans have shown promising results for decrease in infarct size Post conditioning is a procedure of gradual conditioning in which the artery is opened and closed in cycles with inflationdeflation of the culprit artery followed immediately by standard PCI and placement of stent
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