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Sponsors and Collaborators: |
University of Calgary Foothills Interventional Cardiology Research Group |
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Information provided by: | University of Calgary |
ClinicalTrials.gov Identifier: | NCT00334373 |
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.
Condition | Intervention | Phase |
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Myocardial Infarction |
Procedure: Post conditioning |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment |
Official Title: | Post Conditioning in PCI for Acute ST Elevation Myocardial Infarction |
Estimated Enrollment: | 100 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Todd J Anderson, MD | 403-944-1033 | Todd.anderson@calgaryhealthregion.ca |
Contact: Mouhieddin Traboulsi, MD | 403-944-1183 | trabouls@ucalgary.ca |
Canada, Alberta | |
Foothills Medical Centre | Recruiting |
Calgary, Alberta, Canada, T2N 2T9 | |
Contact: Todd J Anderson, MD 403 944-1033 todd.anderson@calgaryhealthregion.ca | |
Contact: Lana Shewchuk, BN 403 944-8509 shewchuk@ucalgary.ca | |
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 |
Responsible Party: | University of Calgary ( Todd Anderson - Principle Investigator ) |
Study ID Numbers: | Ethics ID E-20039 |
Study First Received: | June 6, 2006 |
Last Updated: | October 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00334373 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Myocardial infarction Magnetic Resonance Imaging Coronary Angioplasty |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Ischemia Infarction Myocardial Infarction |
Necrosis Heart Diseases Pathologic Processes Myocardial Ischemia Vascular Diseases |
Cardiovascular Diseases Ischemia Infarction Myocardial Infarction |