Revascularization Strategies for STEMI; The CMR Endpoint Study (ASSIST-CMR)

July 28, 2016 updated by: Unity Health Toronto

Revascularization Strategies for ST Elevation Myocardial Infarction; The Cardiac Magnetic Resonance Endpoint Study

Revascularization strategies for ST elevation myocardial infarction (STEMI) study (ASSIST-CMR) will compare the effects of two revascularization strategies [same sitting multivessel primary PCI (SS-PCI) and culprit vessel only primary PCI (IRA-PCI)] on myocardial infarct size (MIS) as determined by cardiac magnetic resonance (CMR) imaging in patients presenting with STEMI and multivessel disease (MVD).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Not yet recruiting
        • London Health Sciences
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • St. Michael's Hospital
        • Principal Investigator:
          • Akshay Bagai, MD
        • Contact:
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4P 0W5
        • Not yet recruiting
        • Regina Qu'Appelle Health Region
        • Principal Investigator:
          • Payam Dehghani, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • High risk ST elevation myocardial infarction evidenced by: ≥2 mm ST elevation in 2 anterior or lateral leads; or ≥2 mm ST elevation in 2 inferior coupled with ST depression in 2 contiguous anterior leads for a total ST deviation of ≥8 mm; or New left bundle branch block with at least 1 mm concordant ST elevation.
  • Multivessel CAD as evidenced by ≥1 significant (≥70% by visual assessment or FFR<0.80 for 50-70% stenosis) stenosis in non-IRA.
  • Successful IRA-PCI with <10% residual angiographic stenosis and TIMI III flow.
  • Written informed consent.

Exclusion Criteria:

  • Age ≤ 18 years.
  • Prior coronary artery bypass graft (CABG) surgery.
  • Administration of thrombolytic therapy.
  • Non-IRA stenosis is a chronic total occlusion or located in left main artery.
  • Hemodynamic instability evidenced by BP<90 mmHg, Killip class ≥2, need for inotropes/vasopressors.
  • Known renal insufficiency (estimated GFR < 50ml/min).
  • Contraindication to CMR.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: SS-PCI
Same sitting multivessel PCI as an adjunct to primary PCI
Procedure: SS-PCI
Same sitting multivessel PCI as an adjunct to primary PCI
ACTIVE_COMPARATOR: IRA-PCI
IRA only PCI with planned staging for non-IRA lesions
Procedure: IRA-PCI
IRA only PCI at the time of Primary PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infarct size by CMR
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE rate
Time Frame: One year
MACE rate at 12 months
One year

Other Outcome Measures

Outcome Measure
Time Frame
LV function
Time Frame: 90 days and one year
90 days and one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

July 1, 2018

Study Registration Dates

First Submitted

March 23, 2013

First Submitted That Met QC Criteria

March 23, 2013

First Posted (ESTIMATE)

March 27, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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