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ST Elevation Myocardial InfarctionPhase 3MIMINCT01360242

Minimal Invasive Procedure for Myocardial Infarction

A Phase 3 study testing MIMI procedure (two-step strategy) and Immediate Stenting (one-step strategy) in people with ST Elevation Myocardial Infarction, run by Centre Hospitalier Annecy Genevois at 24 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
ST Elevation Myocardial Infarction
What is being tested?
MIMI procedure (two-step strategy) and Immediate Stenting (one-step strategy)
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
24 sitesFrance
Study dates
Jun 2011to Jun 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

France24 sites

  • CHRA

    Annecy

  • Hopital Privé

    Antony

  • Ch Bastia

    Bastia

  • Clinique Convert

    Bourg-en-Bresse

  • CH

    Cannes

  • CH

    Chambéry

  • CHU

    Clermont-Ferrand

  • CHU

    Dijon

  • CHU Nord

    Grenoble

  • Clinique Mutualiste

    Grenoble

  • CHU

    Lille

  • CH St Luc St Joseph

    Lyon

  • CHU Croix Rousse

    Lyon

  • Clinique du Tonkin

    Lyon

  • CHU Nord

    Marseille

  • CHI

    Montfermeil

  • Clinique Marie Lannelongue

    Paris

  • CH

    Pontoise

  • Clinique de Courlancy

    Reims

  • Clinique St Hilaire

    Rouen

  • CHU

    Saint-Etienne

  • Clinique St Gatien

    Tours

  • CH

    Valence

  • CH

    Vichy

Other trials in France

About this study

Official title: 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).

Read the 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.

Being tested
MIMI procedure (two-step strategy), Immediate Stenting (one-step strategy)
Keywords
Acute STEMI, Thrombus aspiration, Angioplasty, Primary Percutaneous Coronary Intervention
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MIMI procedure (two-step strategy)Procedure or surgery

    Also called Delayed angioplasty, 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.

  • Immediate Stenting (one-step strategy)Procedure or surgery

    Also called Immediate Angioplasty

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

Study groups in NCT01360242
Study groupRoleWhat they receive
MIMI procedure (two-step strategy)Active comparatorThrombus 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.
Receives: Procedure: MIMI procedure (two-step strategy)
Immediate Stenting (one-step strategy)Sham comparatorThe physician is encouraged to implant a stent after the thrombus aspiration (drug-eluting stent if indicated for on-label patients).
Receives: Procedure: Immediate Stenting (one-step strategy)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    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.

    Measured: day of performing CMRI (between the fourth and the seventh day after randomization)

Secondary outcomes (8)

  1. Comparison of the MIMI approach and the conventional strategy on TIMI flow, myocardial blush, and ST-segment evolution before and 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).

    Measured: before and 60-90 minutes after the first procedure

  2. 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.

    Measurements: TIMI flow grade, TIMI frame count, and blush at the beginning and at the end of the second procedure.

    Measured: at the beginning and one minute after the end of the second procedure

  3. Thrombus burden assessment, and culprit artery diameter between each procedure in the MIMI group

    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).

    Measured: during each procedure (0-48 hours)

  4. Assessment of the ST-segment after the second procedure in the MIMI group

    Measurements: Maximal ST-segment elevation before and 60-90 minutes after the second procedure (done at the core laboratory).

    Measured: at the beginning (puncture) and 60-90 min after the end of the second procedure

  5. Assessment of the impact of the MIMI procedure on hospital clinical events, infarction size (on CMRI) and complications due to the second procedure.

    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.

    Measured: from randomisation to an expected average 4 days stay before hospital discharge

  6. Assessment of the clinical impact of the MIMI procedure at 6 months

    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.

    Measured: 6 months after randomization

  7. Assessment of the microcirculatory resistance in patients in whom a pressure endocoronary wire was used.

    Measurement: Index of microcirculatory resistance (IMR) just after stenting (first procedure for the conventional group and second procedure for the MIMI group)

    Measured: after each procedure (0-48 hours)

  8. Hospitalization duration for both procedures

    Measurements: Number of days in ICU

    Measured: expected average time from randomisation to Intensive Care Unit (ICU) discharge of 4 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionDec 2012
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01360242
Sponsor's protocol ID
2010-A01345-34
Acronym
MIMI
Status last verified
Mar 2015
First submitted
28 Apr 2011
Last updated
6 Mar 2015
Results posted
No
Data monitoring committee
No

Publications

  • Bovill EG, Terrin ML, Stump DC, Berke AD, Frederick M, Collen D, Feit F, Gore JM, Hillis LD, Lambrew CT, et al. Hemorrhagic events during therapy with recombinant tissue-type plasminogen activator, heparin, and aspirin for acute myocardial infarction. Results of the Thrombolysis in Myocardial Infarction (TIMI), Phase II Trial. Ann Intern Med. 1991 Aug 15;115(4):256-65. doi: 10.7326/0003-4819-115-4-256.

    PubMed 1906692

  • Brodie BR, Stuckey TD, Hansen C, VerSteeg DS, Muncy DB, Moore S, Gupta N, Downey WE. Relation between electrocardiographic ST-segment resolution and early and late outcomes after primary percutaneous coronary intervention for acute myocardial infarction. Am J Cardiol. 2005 Feb 1;95(3):343-8. doi: 10.1016/j.amjcard.2004.09.031.

    PubMed 15670542

  • Bruder O, Breuckmann F, Jensen C, Jochims M, Naber CK, Barkhausen J, Erbel R, Sabin GV; Herzinfarktverbund Essen. Prognostic impact of contrast-enhanced CMR early after acute ST segment elevation myocardial infarction (STEMI) in a regional STEMI network: results of the "Herzinfarktverbund Essen". Herz. 2008 Mar;33(2):136-42. doi: 10.1007/s00059-008-3102-8.

    PubMed 18344033

  • Hombach V, Grebe O, Merkle N, Waldenmaier S, Hoher M, Kochs M, Wohrle J, Kestler HA. Sequelae of acute myocardial infarction regarding cardiac structure and function and their prognostic significance as assessed by magnetic resonance imaging. Eur Heart J. 2005 Mar;26(6):549-57. doi: 10.1093/eurheartj/ehi147. Epub 2005 Feb 15.

    PubMed 15713695

  • Isaaz K, Robin C, Cerisier A, Lamaud M, Richard L, Da Costa A, Sabry MH, Gerenton C, Blanc JL. A new approach of primary angioplasty for ST-elevation acute myocardial infarction based on minimalist immediate mechanical intervention. Coron Artery Dis. 2006 May;17(3):261-9. doi: 10.1097/00019501-200605000-00010.

    PubMed 16728877

  • Kushner FG, Hand M, Smith SC Jr, King SB 3rd, Anderson JL, Antman EM, Bailey SR, Bates ER, Blankenship JC, Casey DE Jr, Green LA, Hochman JS, Jacobs AK, Krumholz HM, Morrison DA, Ornato JP, Pearle DL, Peterson ED, Sloan MA, Whitlow PL, Williams DO; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2009 Focused Updates: ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction (updating the 2004 Guideline and 2007 Focused Update) and ACC/AHA/SCAI Guidelines on Percutaneous Coronary Intervention (updating the 2005 Guideline and 2007 Focused Update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2009 Dec 1;120(22):2271-306. doi: 10.1161/CIRCULATIONAHA.109.192663. Epub 2009 Nov 18. No abstract available.

    PubMed 19923169

  • Meneveau N, Seronde MF, Descotes-Genon V, Dutheil J, Chopard R, Ecarnot F, Briand F, Bernard Y, Schiele F, Bassand JP. Immediate versus delayed angioplasty in infarct-related arteries with TIMI III flow and ST segment recovery: a matched comparison in acute myocardial infarction patients. Clin Res Cardiol. 2009 Apr;98(4):257-64. doi: 10.1007/s00392-009-0756-z. Epub 2009 Feb 9.

    PubMed 19205776

  • Nijveldt R, Beek AM, Hirsch A, Stoel MG, Hofman MB, Umans VA, Algra PR, Twisk JW, van Rossum AC. Functional recovery after acute myocardial infarction: comparison between angiography, electrocardiography, and cardiovascular magnetic resonance measures of microvascular injury. J Am Coll Cardiol. 2008 Jul 15;52(3):181-9. doi: 10.1016/j.jacc.2008.04.006.

    PubMed 18617066

  • Sardella G, Mancone M, Bucciarelli-Ducci C, Agati L, Scardala R, Carbone I, Francone M, Di Roma A, Benedetti G, Conti G, Fedele F. Thrombus aspiration during primary percutaneous coronary intervention improves myocardial reperfusion and reduces infarct size: the EXPIRA (thrombectomy with export catheter in infarct-related artery during primary percutaneous coronary intervention) prospective, randomized trial. J Am Coll Cardiol. 2009 Jan 27;53(4):309-15. doi: 10.1016/j.jacc.2008.10.017.

    PubMed 19161878

  • Sianos G, Papafaklis MI, Daemen J, Vaina S, van Mieghem CA, van Domburg RT, Michalis LK, Serruys PW. Angiographic stent thrombosis after routine use of drug-eluting stents in ST-segment elevation myocardial infarction: the importance of thrombus burden. J Am Coll Cardiol. 2007 Aug 14;50(7):573-83. doi: 10.1016/j.jacc.2007.04.059. Epub 2007 Jul 30.

    PubMed 17692740

  • Svilaas T, Vlaar PJ, van der Horst IC, Diercks GF, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Thrombus aspiration during primary percutaneous coronary intervention. N Engl J Med. 2008 Feb 7;358(6):557-67. doi: 10.1056/NEJMoa0706416.

    PubMed 18256391

  • Thiele H, Schindler K, Friedenberger J, Eitel I, Furnau G, Grebe E, Erbs S, Linke A, Mobius-Winkler S, Kivelitz D, Schuler G. Intracoronary compared with intravenous bolus abciximab application in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: the randomized Leipzig immediate percutaneous coronary intervention abciximab IV versus IC in ST-elevation myocardial infarction trial. Circulation. 2008 Jul 1;118(1):49-57. doi: 10.1161/CIRCULATIONAHA.107.747642. Epub 2008 Jun 16.

    PubMed 18559698

  • Van de Werf F, Bax J, Betriu A, Blomstrom-Lundqvist C, Crea F, Falk V, Filippatos G, Fox K, Huber K, Kastrati A, Rosengren A, Steg PG, Tubaro M, Verheugt F, Weidinger F, Weis M; ESC Committee for Practice Guidelines (CPG). Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2008 Dec;29(23):2909-45. doi: 10.1093/eurheartj/ehn416. Epub 2008 Nov 12. No abstract available.

    PubMed 19004841

  • Wu KC, Zerhouni EA, Judd RM, Lugo-Olivieri CH, Barouch LA, Schulman SP, Blumenthal RS, Lima JA. Prognostic significance of microvascular obstruction by magnetic resonance imaging in patients with acute myocardial infarction. Circulation. 1998 Mar 3;97(8):765-72. doi: 10.1161/01.cir.97.8.765.

    PubMed 9498540

  • Belle L, Motreff P, Mangin L, Range G, Marcaggi X, Marie A, Ferrier N, Dubreuil O, Zemour G, Souteyrand G, Caussin C, Amabile N, Isaaz K, Dauphin R, Koning R, Robin C, Faurie B, Bonello L, Champin S, Delhaye C, Cuilleret F, Mewton N, Genty C, Viallon M, Bosson JL, Croisille P; MIMI Investigators*. Comparison of Immediate With Delayed Stenting Using the Minimalist Immediate Mechanical Intervention Approach in Acute ST-Segment-Elevation Myocardial Infarction: The MIMI Study. Circ Cardiovasc Interv. 2016 Mar;9(3):e003388. doi: 10.1161/CIRCINTERVENTIONS.115.003388.

    PubMed 26957418

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MIMI procedure (two-step strategy) and Immediate Stenting (one-step strategy) in people with ST Elevation Myocardial Infarction, run by Centre Hospitalier Annecy Genevois at 24 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01360242, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.

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