NCT01818960

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

March 23, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
1 year until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

3.7 years

First QC Date

March 23, 2013

Last Update Submit

July 28, 2016

Conditions

Acute Myocardial Infarction

Keywords

Stent, Myocardial Infarction, Coronary Intervention

Outcome Measures

Primary Outcomes (1)

  • Infarct size by CMR

    90 days

Secondary Outcomes (1)

  • MACE rate

    One year

Other Outcomes (1)

  • LV function

    90 days and one year

Study Arms (2)

SS-PCI

ACTIVE COMPARATOR

Same sitting multivessel PCI as an adjunct to primary PCI

Procedure: SS-PCI

IRA-PCI

ACTIVE COMPARATOR

IRA only PCI with planned staging for non-IRA lesions

Procedure: IRA-PCI

Interventions

IRA-PCIPROCEDURE

IRA only PCI at the time of Primary PCI

IRA-PCI
SS-PCIPROCEDURE

Same sitting multivessel PCI as an adjunct to primary PCI

SS-PCI

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

London Health Sciences

London, Ontario, N6A 5A5, Canada

NOT YET RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Regina Qu'Appelle Health Region

Regina, Saskatchewan, S4P 0W5, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2013

First Posted

March 27, 2013

Study Start

April 1, 2014

Primary Completion

December 1, 2017

Study Completion

July 1, 2018

Last Updated

July 29, 2016

Record last verified: 2016-07

Locations

CA(3)