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Post Conditioning in PCI for Acute ST Elevation Myocardial Infarction

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Post conditioning
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Myocardial infarction, Magnetic Resonance Imaging, Coronary Angioplasty

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Foothills Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Post conditioning

Standard care

Arm Description

Balloon inflations-deflations

No balloon inflations

Outcomes

Primary Outcome Measures

Infarct size as measured by: salvage index = total area at risk - infarct size/total area at risk

Secondary Outcome Measures

Corrected TIMI frame count (cTFC)
Myocardial blush score
CK release (under the curve)
ST segment resolution by 48 hrs compared with admission
MRI infarct size
MRI maximal transmural extent of irreversible injury
CMR regional end-systolic wall stress
CMR Myocardial perfusion
CMR Myocardial oxygenation
Peripheral endothelial function testing (brachial u/s and pulse arterial tonometry) in hospital
CMR quantification of volume of no-reflow

Full Information

First Posted
June 6, 2006
Last Updated
May 26, 2015
Sponsor
University of Calgary
Collaborators
Foothills Interventional Cardiology Research Group
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1. Study Identification

Unique Protocol Identification Number
NCT00334373
Brief Title
Post Conditioning in PCI for Acute ST Elevation Myocardial Infarction
Official Title
Post Conditioning in PCI for Acute ST Elevation Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Foothills Interventional Cardiology Research Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Myocardial infarction, Magnetic Resonance Imaging, Coronary Angioplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post conditioning
Arm Type
Experimental
Arm Description
Balloon inflations-deflations
Arm Title
Standard care
Arm Type
Placebo Comparator
Arm Description
No balloon inflations
Intervention Type
Procedure
Intervention Name(s)
Post conditioning
Intervention Description
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
Primary Outcome Measure Information:
Title
Infarct size as measured by: salvage index = total area at risk - infarct size/total area at risk
Time Frame
3-5 days post MI
Secondary Outcome Measure Information:
Title
Corrected TIMI frame count (cTFC)
Time Frame
Immediately post PCI
Title
Myocardial blush score
Time Frame
Immediately post PCI
Title
CK release (under the curve)
Time Frame
1st 48 hours post MI
Title
ST segment resolution by 48 hrs compared with admission
Time Frame
1st 48 hours post MI
Title
MRI infarct size
Time Frame
3-5 days and 6 months
Title
MRI maximal transmural extent of irreversible injury
Time Frame
3-5 days and 6 months
Title
CMR regional end-systolic wall stress
Time Frame
3-5 days and 6 months
Title
CMR Myocardial perfusion
Time Frame
3-5 days and 6 months
Title
CMR Myocardial oxygenation
Time Frame
3-5 days and 6 months
Title
Peripheral endothelial function testing (brachial u/s and pulse arterial tonometry) in hospital
Time Frame
3-5 days post MI
Title
CMR quantification of volume of no-reflow
Time Frame
3-5 days and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mouhieddin Traboulsi, MD
Organizational Affiliation
University of Calgary, sub-investigator
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Matthias Friedrich, MD
Organizational Affiliation
Sub-investigator, Stephenson CMR Centre, FMC; 1403-29th St NW, Calgary; T2N 2T9
Official's Role
Study Chair
Facility Information:
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada

12. IPD Sharing Statement

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Post Conditioning in PCI for Acute ST Elevation Myocardial Infarction

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