Revascularization Strategies for STEMI; The CMR Endpoint Study

Not Applicable

• Conditions: Acute Myocardial Infarction
• Interventions: Procedure: SS-PCI; Procedure: IRA-PCI

• Registration Number: NCT01818960
• Lead Sponsor: Unity Health Toronto

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-23
• Study First Submitted QC: 2013-03-23
• Study First Posted: 2013-03-27
• Study Start: 2014-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-07-29
• Primary Completion: 2017-12
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SS-PCI	SS-PCI	Same sitting multivessel PCI as an adjunct to primary PCI
IRA-PCI	IRA-PCI	IRA only PCI with planned staging for non-IRA lesions

Primary Outcome Measures

Name	Time	Method
Infarct size by CMR	90 days

Secondary Outcome Measures

Name	Time	Method
MACE rate	One year	MACE rate at 12 months

Trial Locations

Locations (3)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

London Health Sciences; 🇨🇦 London, Ontario, Canada

Regina Qu'Appelle Health Region; 🇨🇦 Regina, Saskatchewan, Canada