Post Conditioning in PCI for Acute ST Elevation Myocardial Infarction

NCT ID: NCT00334373

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2011-10-31

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.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Post conditioning

Balloon inflations-deflations

Group Type: EXPERIMENTAL

Post conditioning

Intervention Type: PROCEDURE

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

Standard care

No balloon inflations

Group Type: PLACEBO_COMPARATOR

Post conditioning

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foothills Interventional Cardiology Research Group

UNKNOWN

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Todd Anderson

Director Libin Cardiovascular Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mouhieddin Traboulsi, MD

Role: STUDY_DIRECTOR

University of Calgary, sub-investigator

Matthias Friedrich, MD

Role: STUDY_CHAIR

Sub-investigator, Stephenson CMR Centre, FMC; 1403-29th St NW, Calgary; T2N 2T9

Locations

Foothills Medical Centre

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

Ethics ID E-20039

Identifier Type: -

Identifier Source: org_study_id