NCT00025766

Brief Summary

The purpose of this study is to evaluate arterial patency and left ventricular ejection fraction by examining angiographic data one year following a heart attack and treatment with late revascularization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
380

participants targeted

Target at P50-P75 for phase_4 cardiovascular-diseases

Timeline
Completed

Started Sep 2001

Longer than P75 for phase_4 cardiovascular-diseases

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2001

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
5.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 27, 2013

Status Verified

November 1, 2013

Enrollment Period

4.6 years

First QC Date

October 22, 2001

Last Update Submit

November 25, 2013

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart DiseasesMyocardial Infarction

Outcome Measures

Primary Outcomes (2)

  • LV ejection fraction

    1 year

  • Infarct-related artery patency (measured by contrast LV and coronary angiography)

    1 year

Secondary Outcomes (3)

  • Comparison of regional wall motion and LV volumes

    1 year

  • Effect of reocclusion and spontaneous recanalization on LV function

    1 year

  • Effect of duration of occlusion on changes in LV function after PCI

    1 year

Study Arms (2)

1

EXPERIMENTAL

PCI with stenting of the occluded culprit infarct-related artery plus optimal medical therapy

Device: PCI with stentingBehavioral: Optimal Medical Therapy

2

ACTIVE COMPARATOR

Optimal medical therapy alone without PCI of the occluded culprit artery

Behavioral: Optimal Medical Therapy

Interventions

PCI with stentingDEVICE

PCI with stenting of the occluded culprit infarct-related artery

1
Optimal Medical TherapyBEHAVIORAL

Participants will receive optimal medical therapy.

12

Eligibility Criteria

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

You may qualify if:

  • Has experienced a heart attack 3 to 28 days prior to study entry
  • Has a persistently occluded IRA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network - Toronto General Hospital

Toronto, Ontario, Canada

Location

Related Publications (3)

  • Dzavik V, Buller CE, Lamas GA, Rankin JM, Mancini GB, Cantor WJ, Carere RJ, Ross JR, Atchison D, Forman S, Thomas B, Buszman P, Vozzi C, Glanz A, Cohen EA, Meciar P, Devlin G, Mascette A, Sopko G, Knatterud GL, Hochman JS; TOSCA-2 Investigators. Randomized trial of percutaneous coronary intervention for subacute infarct-related coronary artery occlusion to achieve long-term patency and improve ventricular function: the Total Occlusion Study of Canada (TOSCA)-2 trial. Circulation. 2006 Dec 5;114(23):2449-57. doi: 10.1161/CIRCULATIONAHA.106.669432. Epub 2006 Nov 14.

    PMID: 17105848RESULT

  • Steigen TK, Buller CE, Mancini GB, Jorapur V, Cantor WJ, Rankin JM, Thomas B, Webb JG, Kronsberg SS, Atchison DJ, Lamas GA, Hochman JS, Dzavik V. Myocardial perfusion grade after late infarct artery recanalization is associated with global and regional left ventricular function at one year: analysis from the Total Occlusion Study of Canada-2. Circ Cardiovasc Interv. 2010 Dec;3(6):549-55. doi: 10.1161/CIRCINTERVENTIONS.109.918722. Epub 2010 Nov 9.

    PMID: 21062997RESULT

  • Dzavik V, Buller CE, Devlin G, Carere RG, Mancini GB, Cantor WJ, Buszman PE, Rankin JM, Vozzi C, Ross JR, Forman S, Barton BA, Lamas AG, Hochman JS. Angiographic and clinical outcomes of drug-eluting versus bare metal stent deployment in the Occluded Artery Trial. Catheter Cardiovasc Interv. 2009 May 1;73(6):771-9. doi: 10.1002/ccd.21930.

    PMID: 19309733RESULT

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart DiseasesMyocardial Infarction

Interventions

Percutaneous Coronary InterventionStents

Condition Hierarchy (Ancestors)

Myocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresProstheses and ImplantsEquipment and Supplies

Study Officials

  • Vladimir Dzavik, MD

    University Health Network - Toronto General Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 22, 2001

First Posted

October 23, 2001

Study Start

September 1, 2001

Primary Completion

April 1, 2006

Study Completion

December 1, 2011

Last Updated

November 27, 2013

Record last verified: 2013-11

Locations

CA(1)