Minimal Invasive Procedure for Myocardial Infarction

NCT01360242 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2015-03-06

No results posted yet for this study

Summary

In the setting of primary Percutaneous Coronary Intervention (PCI), the investigators hypothesize that a 24-48 hour delay strategy of stenting after successful thrombus aspiration and establishment of Thrombolysis In Myocardial Infarction (TIMI)-3 flow with optimal antithrombotic therapy may decrease the risk of MicroVascular Obstruction (MVO) as assessed by Cardiac Magnetic Resonance Imaging (CMRI).

Conditions

  • ST Elevation Myocardial Infarction

Interventions

PROCEDURE

MIMI procedure (two-step strategy)

A second coronary angiogram is performed 24-48 hours later and the physician is free to decide on the best treatment, i.e. surgery, medical treatment, or stent implantation (drug-eluting stent if indicated for on-label patients). If stenting is required and the thrombus is still too large (greater than twice the artery width), the physician could postpone stent implantation for days or weeks.

PROCEDURE

Immediate Stenting (one-step strategy)

The physician is encouraged to implant a stent after the thrombus aspiration (drug-eluting stent if indicated for on-label patients).

Sponsors & Collaborators

  • University Hospital, Grenoble

    collaborator OTHER
  • Centre Hospitalier Annecy Genevois

    lead OTHER

Principal Investigators

  • Loic BELLE, MD · Centre Hospitalier Annecy Genevois

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-12-31
Completion
2013-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01360242 on ClinicalTrials.gov