NCT00334373

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2006

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

5.3 years

First QC Date

June 6, 2006

Last Update Submit

May 26, 2015

Conditions

Myocardial Infarction

Keywords

Myocardial infarctionMagnetic Resonance ImagingCoronary Angioplasty

Outcome Measures

Primary Outcomes (1)

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

    3-5 days post MI

Secondary Outcomes (11)

  • Corrected TIMI frame count (cTFC)

    Immediately post PCI

  • Myocardial blush score

    Immediately post PCI

  • CK release (under the curve)

    1st 48 hours post MI

  • ST segment resolution by 48 hrs compared with admission

    1st 48 hours post MI

  • MRI infarct size

    3-5 days and 6 months

  • +6 more secondary outcomes

Study Arms (2)

Post conditioning

EXPERIMENTAL

Balloon inflations-deflations

Procedure: Post conditioning

Standard care

PLACEBO COMPARATOR

No balloon inflations

Procedure: Post conditioning

Interventions

Post conditioningPROCEDURE

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

Post conditioningStandard care

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Ischemic Postconditioning

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Mouhieddin Traboulsi, MD

    University of Calgary, sub-investigator

    STUDY DIRECTOR

  • Matthias Friedrich, MD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Libin Cardiovascular Institute

Study Record Dates

First Submitted

June 6, 2006

First Posted

June 7, 2006

Study Start

June 1, 2006

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

CA(1)