Post Conditioning in PCI for Acute ST Elevation Myocardial Infarction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Calgary.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Foothills Interventional Cardiology Research Group
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00334373
First received: June 6, 2006
Last updated: September 20, 2010
Last verified: September 2010
  Purpose

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
Myocardial Infarction
Procedure: Post conditioning
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
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)
Intervention Details:
    Procedure: Post conditioning
    4 cycles of balloon inflation /deflation (post-conditioning) within first minute of opening up artery in primary PCI for STEMI vs usual balloon inflation sequence
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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years and over
  • ST elevation of >/= 2mm in 3 consecutive anterior leads or >/= to 2 mm in leads II, III and AVF with total 8 mm ST shift (ST depression of 1 mm in ant or lat leads)

Exclusion Criteria:

  • Cardiogenic shock or severe heart failure
  • Inability to undergo CMR (metallic objects or claustrophobia)
  • Previous MI
  • TIMI 2-3 flow in target artery
  • Collaterals to infarct related artery > Rentrop grade 1
  • Inability to undertake successful PCI at time of angio
  • Significant LM disease or requiring CABG during hospital stay
  • Inability to proceed with post conditioning within 1 minute of establishing blood flow in culprit artery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334373

Contacts
Contact: Todd J Anderson, MD 403-944-1033 Todd.anderson@albertahealthservices.ca
Contact: Mouhieddin Traboulsi, MD 403-521-2227 trabouls@ucalgary.ca

Locations
Canada, Alberta
Foothills Medical Centre Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Todd J Anderson, MD    403 944-1033    todd.anderson@albertahealthservices.ca   
Contact: Darlene Hilland, BN    403 944-8509    dhilland@ucalgary.ca   
Principal Investigator: Todd Anderson, MD         
Sponsors and Collaborators
University of Calgary
Foothills Interventional Cardiology Research Group
Investigators
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
  More Information

No publications provided

Responsible Party: Todd Anderson - Principle Investigator, University of Calgary
ClinicalTrials.gov Identifier: NCT00334373     History of Changes
Other Study ID Numbers: Ethics ID E-20039
Study First Received: June 6, 2006
Last Updated: September 20, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
Myocardial infarction
Magnetic Resonance Imaging
Coronary Angioplasty

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014