Minimal Invasive Procedure for Myocardial Infarction (MIMI)

March 5, 2015 updated by: Centre Hospitalier Annecy Genevois

Patients Presenting With Acute STEMI Treated With Primary PCI : Comparison of the Impact of the MIMI Approach With a Conventional Strategy of Immediate Stenting

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary PCI is the reperfusion therapy of choice in patients with acute ST-elevation myocardial infarction (STEMI) [Van de Werf et al. 2008; Kushner et al. 2009]. The first objective in primary PCI is to restore TIMI-3 flow. However, despite restoration of TIMI-3 flow, myocardial reperfusion remains suboptimal in a significant proportion of patients, predominantly as a consequence of the so called "myocardial non-reperfusion phenomenon", "low/no-reflow phenomenon" or MVO. This, in turn, is associated with significant morbidity and mortality [Brodie et al. 2005; Bruder et al. 2008; Hombach et al. 2005; Nijveldt et al. 2008; Thiele et al. 2008; Wu et al. 1998]. Although TIMI flow is well assessed by angiography, contrast-enhanced CMRI remains the gold standard in the assessment of MVO. Indeed, the presence and extent of hypoenhanced areas have been shown to be associated with a poor outcome [Bruder et al. 2008; Hombach et al. 2005; Nijveldt et al. 2008; Wu et al. 1998].

There is now a large body of evidence to suggest that even in patients with TIMI-3 flow on angiography, as many as 60% of these patients will subsequently exhibit MVO with CMRI [Brodie et al. 2005; Bruder et al. 2008; Hombach et al. 2005; Nijveldt et al. 2008; Thiele et al. 2008; Wu et al. 1998]. Our knowledge of the mechanisms of MVO occurrence as well as measures to reduce MVO has been considerably enhanced by recent publications. For instance, Sianos et al. [2007] demonstrated that the thrombus burden at the time of angiography is an independent predictor of MVO extension and 2-year mortality. Furthermore, Isaaz et al. [2006] recommended a two-step strategy as a means of minimising the risk of MVO, with the first step consisting of TIMI-3 flow restoration, followed 2-6 days later by further angiography to determine the therapeutic strategy of choice (PCI, cardiac surgery, or medical treatment: 67%, 25%, and 8% respectively). Meneveau et al. [2009] also adopted a two-step strategy in a small cohort of STEMI patients with TIMI-3 flow and ST-segment regression at the time of the procedure. They demonstrated that a 24-hour delay in stent implantation led to a higher rate of procedural success than immediate stenting. Isaaz et al. [2006] and Meneveau et al. [2009] also reported a decreased thrombus burden and no culprit-artery re-occlusion between the first and the second procedure.

Both the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS) [Svilaas et al. 2008] and the thrombectomy with EXPort catheter in Infarct-Related Artery during primary percutaneous coronary intervention (EXPIRA) [Sardella et al. 2009] studies demonstrated the benefits of thrombus aspiration as the first step in primary PCI prior to either ballooning or direct stenting. However, as the effects of stenting upon MVO in the setting of acute STEMI remain poorly understood, we propose a randomized study to evaluate the benefits of a 24-48-hour delay in stent implantation compared to immediate stenting in patients presenting with acute STEMI who will undergo primary PCI.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Annecy, France
        • CHRA
      • Antony, France
        • Hôpital privé
      • Bastia, France
        • CH Bastia
      • Bourg En Bresse, France
        • Clinique Convert
      • Cannes, France
        • CH
      • Chambery, France
        • CH
      • Clermont Ferrand, France
        • CHU
      • Dijon, France
        • CHU
      • Grenoble, France
        • Clinique Mutualiste
      • Grenoble, France
        • CHU Nord
      • Lille, France
        • CHU
      • Lyon, France
        • CH St Luc St Joseph
      • Lyon, France
        • CHU Croix Rousse
      • Lyon, France
        • Clinique du Tonkin
      • Marseille, France
        • CHU Nord
      • Montfermeil, France
        • CHI
      • Paris, France
        • Clinique Marie Lannelongue
      • Pontoise, France
        • CH
      • Reims, France
        • Clinique de Courlancy
      • Rouen, France
        • Clinique St Hilaire
      • St Etienne, France
        • CHU
      • Tours, France
        • Clinique St Gatien
      • Valence, France
        • CH
      • Vichy, France
        • CH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with acute STEMI presenting within 12 hours of symptom onset, requiring a primary percutaneous coronary intervention; and written informed consent.
  • Patients will be randomized during the angiography if the initial TIMI flow is 0 or 1 in a major artery and if TIMI-3 flow can be restored after thrombus aspiration and sustained for 10 minutes.
  • Acute STEMI is defined as typical chest pain with 30 minutes of sustained ST-segment elevation >1 mm in two or more consecutive limb leads or >2 mm in two or more precordial leads in the ECG. Major artery is defined as the proximal or mid segment of the left descending artery, the proximal segment of the circumflex artery (before the first marginal), or the right coronary artery before the posterior descendant artery.

Exclusion Criteria:

  • Patients less than 18 years' old
  • Pregnant and breast feeding women
  • Patients with a pacemaker, automated implantable cardioverter-defibrillator (AICD), or left bundle branch block
  • Contraindication to abciximab, prasugrel, or clopidogrel
  • Cardiac arrest as initial presentation
  • Current medical condition with a life expectancy of < 6 months
  • Patients not living in France
  • Patients in cardiogenic shock
  • Culprit artery <2.5 mm
  • Absence of informed consent
  • Patients with initial TIMI 2 or 3 flow or no TIMI-3 flow restored after thrombus aspiration
  • Rescue PCI after fibrinolysis
  • Known creatinine clearance < 30 ml/min.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: MIMI procedure (two-step strategy)
Thrombus aspiration is performed to achieve TIMI-3 flow. Once TIMI-3 flow is restored and sustained for > 10 minutes, the initial procedure is stopped regardless of the presence of any residual stenosis. 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: 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.
Other Names:
  • Delayed angioplasty
  • Two-step strategy
SHAM_COMPARATOR: 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).
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).
Other Names:
  • Immediate Angioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary endpoint is the extent of MVO as assessed by CMRI, expressed as the ratio of MVO/left ventricular mass, in the MIMI and conventional groups.
Time Frame: day of performing CMRI (between the fourth and the seventh day after randomization)

The primary end-point will be reviewed by an independent CMRI core laboratory blinded to the group and the procedure.

MVO is defined as a hypoenhanced subendocardial area in the infarction core 2 or 10 minutes after contrast injection (dark zone). The total myocardial infarction is defined as the sum of hypoenhanced (dark zone) and hyperenhanced (white zone) signals 10 minutes after contrast injection. The CMRI procedure will be standardised with a specific documentation.
day of performing CMRI (between the fourth and the seventh day after randomization)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the MIMI approach and the conventional strategy on TIMI flow, myocardial blush, and ST-segment evolution before and after the first procedure.
Time Frame: before and 60-90 minutes after the first procedure
Measurements: TIMI flow grade and TIMI frame count (a more sophisticated method for measuring the flow) at the end of the procedure; blush (a more precise evaluation than TIMI flow on angiography); and ST-segment evolution on the electrocardiogram (ECG) before and 60-90 minutes after the first procedure (core laboratory).
before and 60-90 minutes after the first procedure
To measure TIMI flow and myocardial blush at the beginning and at end of the second procedure in the MIMI group, and to compare with those obtained at the end of the first procedure.
Time Frame: at the beginning and one minute after the end of the second procedure
Measurements: TIMI flow grade, TIMI frame count, and blush at the beginning and at the end of the second procedure.
at the beginning and one minute after the end of the second procedure
Thrombus burden assessment, and culprit artery diameter between each procedure in the MIMI group
Time Frame: during each procedure (0-48 hours)
Measurements: Thrombus volume and artery diameter at the thrombus location during the first and second procedure, and diameter of the implanted stent (done at the core laboratory).
during each procedure (0-48 hours)
Assessment of the ST-segment after the second procedure in the MIMI group
Time Frame: at the beginning (puncture) and 60-90 min after the end of the second procedure
Measurements: Maximal ST-segment elevation before and 60-90 minutes after the second procedure (done at the core laboratory).
at the beginning (puncture) and 60-90 min after the end of the second procedure
Assessment of the impact of the MIMI procedure on hospital clinical events, infarction size (on CMRI) and complications due to the second procedure.
Time Frame: from randomisation to an expected average 4 days stay before hospital discharge

The following hospital critical events and complications that occur after the first procedure will be analyzed: cardiogenic shock, acute pulmonary oedema, recurrent myocardial infarction, culprit artery re-occlusion, stroke, major bleeding [Bovill et al. 1991], evaluation of no flow, coronary dissection, recurrent myocardial infarction, chest pain, decelerating angio flow, recurrent ST elevation, troponin elevation, severe renal insufficiency, access site bleeding, and access artery occlusion.

Measurement: CMRI infarction size.
from randomisation to an expected average 4 days stay before hospital discharge
Assessment of the clinical impact of the MIMI procedure at 6 months
Time Frame: 6 months after randomization
Measurements: In both groups, follow-up will be undertaken at 6 months by a phone call to the general practitioner, cardiologist or patient, to report the occurrence of: death, recurrent myocardial infarction, hospitalization(s) for cardiac insufficiency, and unscheduled revascularisation.
6 months after randomization
Assessment of the microcirculatory resistance in patients in whom a pressure endocoronary wire was used.
Time Frame: after each procedure (0-48 hours)
Measurement: Index of microcirculatory resistance (IMR) just after stenting (first procedure for the conventional group and second procedure for the MIMI group)
after each procedure (0-48 hours)
Hospitalization duration for both procedures
Time Frame: expected average time from randomisation to Intensive Care Unit (ICU) discharge of 4 days
Measurements: Number of days in ICU
expected average time from randomisation to Intensive Care Unit (ICU) discharge of 4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Annecy Genevois

Collaborators

University Hospital, Grenoble

Investigators

  • Principal Investigator: Loic BELLE, MD, Centre Hospitalier Annecy Genevois

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

April 28, 2011

First Submitted That Met QC Criteria

May 24, 2011

First Posted (ESTIMATE)

May 25, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-A01345-34

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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