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

Primary Purpose

Acute Myocardial Infarction

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

IRA-PCI

SS-PCI

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Stent, Myocardial Infarction, Coronary Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

London Health Sciences
St. Michael's HospitalRecruiting
Regina Qu'Appelle Health Region

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

SS-PCI

IRA-PCI

Arm Description

Same sitting multivessel PCI as an adjunct to primary PCI

IRA only PCI with planned staging for non-IRA lesions

Outcomes

Primary Outcome Measures

Infarct size by CMR

Secondary Outcome Measures

MACE rate

MACE rate at 12 months

Full Information

NCT ID

NCT01818960

First Posted

March 23, 2013

Last Updated

July 28, 2016

Sponsor

Unity Health Toronto

1. Study Identification

Unique Protocol Identification Number

NCT01818960

Brief Title

Revascularization Strategies for STEMI; The CMR Endpoint Study

Acronym

ASSIST-CMR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Unknown status

Study Start Date

April 2014 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Unity Health Toronto

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myocardial Infarction

Keywords

Stent, Myocardial Infarction, Coronary Intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SS-PCI

Arm Type

Active Comparator

Arm Description

Same sitting multivessel PCI as an adjunct to primary PCI

Arm Title

IRA-PCI

Arm Type

Active Comparator

Arm Description

IRA only PCI with planned staging for non-IRA lesions

Intervention Type

Procedure

Intervention Name(s)

IRA-PCI

Intervention Description

IRA only PCI at the time of Primary PCI

Intervention Type

Procedure

Intervention Name(s)

SS-PCI

Intervention Description

Same sitting multivessel PCI as an adjunct to primary PCI

Primary Outcome Measure Information:

Title

Infarct size by CMR

Time Frame

90 days

Secondary Outcome Measure Information:

Title

MACE rate

Description

MACE rate at 12 months

Time Frame

One year

Other Pre-specified Outcome Measures:

Title

LV function

Time Frame

90 days and one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

London Health Sciences

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shahar Lavi, MD

Phone

519-663-3611

shahar.lavi@lhsc.on.ca

Facility Name

St. Michael's Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1W8

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohammed Hussein

Phone

4168646060

Ext

4014

husseinmo@smh.ca

First Name & Middle Initial & Last Name & Degree

Asim Cheema, MD

First Name & Middle Initial & Last Name & Degree

Akshay Bagai, MD

Facility Name

Regina Qu'Appelle Health Region

City

Regina

State/Province

Saskatchewan

ZIP/Postal Code

S4P 0W5

Country

Canada

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sheila Kelly, MSc

Phone

306-522-7275

sheila@skresearch.com

First Name & Middle Initial & Last Name & Degree

Payam Dehghani, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Revascularization Strategies for STEMI; The CMR Endpoint Study

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