Suspended

ASSIST-CMRRevascularization Strategies for ST Elevation Myocardial Infarction; The Cardiac Magnetic Resonance Endpoint Study

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What is being tested

SS-PCI

+ IRA-PCI

Procedure
Who is being recruted

Cardiovascular Diseases+7

+ Heart Diseases

+ Infarction

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2014
See protocol details

Summary

Principal SponsorUnity Health Toronto
Study ContactShahar Lavi, MDMore contacts
Last updated: July 29, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2014

Actual date on which the first participant was enrolled.

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).

NCT01818960
Principal SponsorUnity Health Toronto
Study ContactShahar Lavi, MDMore contacts
Last updated: July 29, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

250 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesInfarctionIschemiaNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesMyocardial IschemiaMyocardial Infarction

Criteria

4 inclusion criteria required to participate
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
7 exclusion criteria prevent from participating
Administration of thrombolytic therapy
Age <= 18 years
Contraindication to CMR
Hemodynamic instability evidenced by BP < 90 mmHg, Killip class >= 2, need for inotropes/vasopressors
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Same sitting multivessel PCI as an adjunct to primary PCI

Group II

Active Comparator
IRA only PCI with planned staging for non-IRA lesions

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Recruiting

St. Michael's Hospital

Toronto, CanadaOpen St. Michael's Hospital in Google Maps
Recruiting soon

London Health Sciences

London, Canada
Recruiting soon

Regina Qu'Appelle Health Region

Regina, Canada
Suspended3 Study Centers