Recruiting

Revascularization Strategies

Sponsor:

Unity Health Toronto

Code:

NCT01818960

Conditions

Acute Myocardial Infarction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IRA-PCI

SS-PCI

Study Details

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).

Conditions

Acute Myocardial Infarction

Study ID

NCT01818960

Start date

Apr, 2014

Status verified date

Jul, 2016

Completion date

Jul, 2018

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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

Interventions

IRA-PCI

IRA only PCI at the time of Primary PCI

SS-PCI

Same sitting multivessel PCI as an adjunct to primary PCI

Primary outcome measure

  • Infarct size by CMR [ Time Frame: 90 days ]

Central Contacts and Locations

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Mohammed Hussein

4168646060husseinmo@smh.ca

Principal Investigator:

Asim Cheema, MD

More Information

Sponsor

Unity Health Toronto

Last update posted

Jul 29, 2016

Last verified

Jul, 2016

Keywords

  • Stent, Myocardial Infarction, Coronary Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2016-07-29.