Post Conditioning in PCI for Acute ST Elevation Myocardial Infarction
Recruitment status was Recruiting
The purpose of this trial is to compare post-conditioning to standard angioplasty (50/50 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 inflation/deflation 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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Post Conditioning in PCI for Acute ST Elevation Myocardial Infarction|
- Infarct size as measured by: salvage index = total area at risk - infarct size/total area at risk [ Time Frame: 3-5 days post MI ] [ Designated as safety issue: No ]
- Corrected TIMI frame count (cTFC) [ Time Frame: Immediately post PCI ] [ Designated as safety issue: No ]
- Myocardial blush score [ Time Frame: Immediately post PCI ] [ Designated as safety issue: No ]
- CK release (under the curve) [ Time Frame: 1st 48 hours post MI ] [ Designated as safety issue: No ]
- ST segment resolution by 48 hrs compared with admission [ Time Frame: 1st 48 hours post MI ] [ Designated as safety issue: No ]
- MRI infarct size [ Time Frame: 3-5 days and 6 months ] [ Designated as safety issue: No ]
- MRI maximal transmural extent of irreversible injury [ Time Frame: 3-5 days and 6 months ] [ Designated as safety issue: No ]
- CMR regional end-systolic wall stress [ Time Frame: 3-5 days and 6 months ] [ Designated as safety issue: No ]
- CMR Myocardial perfusion [ Time Frame: 3-5 days and 6 months ] [ Designated as safety issue: No ]
- CMR Myocardial oxygenation [ Time Frame: 3-5 days and 6 months ] [ Designated as safety issue: No ]
- Peripheral endothelial function testing (brachial u/s and pulse arterial tonometry) in hospital [ Time Frame: 3-5 days post MI ] [ Designated as safety issue: No ]
- CMR quantification of volume of no-reflow [ Time Frame: 3-5 days and 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2006|
|Estimated Study Completion Date:||May 2011|
|Estimated Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Procedure: Post conditioning
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 50,000 STEMI's 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 ischemia/injury. 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 inflation/deflation of the culprit artery followed immediately by standard PCI and placement of stent.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00334373
|Contact: Todd J Anderson, MD||403-944-1033||Todd.firstname.lastname@example.org|
|Contact: Mouhieddin Traboulsi, MDemail@example.com|
|Foothills Medical Centre||Recruiting|
|Calgary, Alberta, Canada, T2N 2T9|
|Contact: Todd J Anderson, MD 403 944-1033 firstname.lastname@example.org|
|Contact: Darlene Hilland, BN 403 944-8509 email@example.com|
|Principal Investigator: Todd Anderson, MD|
|Study Director:||Mouhieddin Traboulsi, MD||University of Calgary, sub-investigator|
|Study Chair:||Matthias Friedrich, MD||Sub-investigator, Stephenson CMR Centre, FMC; 1403-29th St NW, Calgary; T2N 2T9|