Revascularization Strategies for STEMI; The CMR Endpoint Study

NCT ID: NCT01818960

Last Updated: 2016-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2018-07-31

Brief Summary

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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

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Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SS-PCI

Same sitting multivessel PCI as an adjunct to primary PCI

Group Type ACTIVE_COMPARATOR

SS-PCI

Intervention Type PROCEDURE

Same sitting multivessel PCI as an adjunct to primary PCI

IRA-PCI

IRA only PCI with planned staging for non-IRA lesions

Group Type ACTIVE_COMPARATOR

IRA-PCI

Intervention Type PROCEDURE

IRA only PCI at the time of Primary PCI

Interventions

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IRA-PCI

IRA only PCI at the time of Primary PCI

Intervention Type PROCEDURE

SS-PCI

Same sitting multivessel PCI as an adjunct to primary PCI

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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London Health Sciences

London, Ontario, Canada

Site Status NOT_YET_RECRUITING

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Regina Qu'Appelle Health Region

Regina, Saskatchewan, Canada

Site Status NOT_YET_RECRUITING

Countries

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Canada

Facility Contacts

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Shahar Lavi, MD

Role: primary

519-663-3611

Mohammed Hussein

Role: primary

4168646060 ext. 4014

Sheila Kelly, MSc

Role: primary

306-522-7275

Other Identifiers

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AC-103

Identifier Type: -

Identifier Source: org_study_id

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