Revascularization Strategies for STEMI; The CMR Endpoint Study

Acute Myocardial Infarction Clinical Trial

— ASSIST-CMR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01818960
• Other study ID #: AC-103
• Status: Recruiting
• Phase: N/A
• First received: March 23, 2013
• Last updated: July 28, 2016
• Start date: April 2014
• Est. completion date: July 2018

Study information

• Verified date: July 2016
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: July 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Procedure:
• IRA-PCI
IRA only PCI at the time of Primary PCI
• SS-PCI
Same sitting multivessel PCI as an adjunct to primary PCI

Locations

Country	Name	City	State
Canada	London Health Sciences	London	Ontario
Canada	Regina Qu'Appelle Health Region	Regina	Saskatchewan
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	LV function		90 days and one year	No
Primary	Infarct size by CMR		90 days	No
Secondary	MACE rate	MACE rate at 12 months	One year	Yes