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

U

Unity Health Toronto

Status

Unknown

Conditions

Acute Myocardial Infarction

Treatments

Procedure: SS-PCI
Procedure: IRA-PCI

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Enrollment

250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

250 participants in 2 patient groups

SS-PCI
Active Comparator group
Description:
Same sitting multivessel PCI as an adjunct to primary PCI
Treatment:
Procedure: SS-PCI
IRA-PCI
Active Comparator group
Description:
IRA only PCI with planned staging for non-IRA lesions
Treatment:
Procedure: IRA-PCI

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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