Minimal Invasive Procedure for Myocardial Infarction

NCT01360242 | Completed Phase 3

• 1 other identifier: 2010-A01345-34
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 24

Brief 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

Keywords

Acute STEMI; Thrombus aspiration; Angioplasty; Primary Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (8)

• Comparison of the MIMI approach and the conventional strategy on TIMI flow, myocardial blush, and ST-segment evolution before and after the first procedure.

  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.

  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

  during each procedure (0-48 hours)

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

  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.

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

Study Arms (2)

MIMI procedure (two-step strategy)

ACTIVE COMPARATOR

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)

Immediate Stenting (one-step strategy)

SHAM COMPARATOR

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)

Interventions

MIMI procedure (two-step strategy) PROCEDURE

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.

Also known as: Delayed angioplasty, Two-step strategy

MIMI procedure (two-step strategy)

Immediate Stenting (one-step strategy) PROCEDURE

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

Also known as: Immediate Angioplasty

Immediate Stenting (one-step strategy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Annecy Genevois: lead
• University Hospital, Grenoble: collaborator

Study Sites (24)

CHRA

Annecy, France

Location

Hopital Privé

Antony, France

Location

Ch Bastia

Bastia, France

Location

Clinique Convert

Bourg-en-Bresse, France

Location

CH

Cannes, France

Location

CH

Chambéry, France

Location

CHU

Clermont-Ferrand, France

Location

CHU

Dijon, France

Location

CHU Nord

Grenoble, France

Location

Clinique Mutualiste

Grenoble, France

Location

CHU

Lille, France

Location

CH St Luc St Joseph

Lyon, France

Location

CHU Croix Rousse

Lyon, France

Location

Clinique du Tonkin

Lyon, France

Location

CHU Nord

Marseille, France

Location

CHI

Montfermeil, France

Location

Clinique Marie Lannelongue

Paris, France

Location

CH

Pontoise, France

Location

Clinique de Courlancy

Reims, France

Location

Clinique St Hilaire

Rouen, France

Location

CHU

Saint-Etienne, France

Location

Clinique St Gatien

Tours, France

Location

CH

Valence, France

Location

CH

Vichy, France

Location

Related Publications (15)

• 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.

  PMID: 1906692 BACKGROUND

• 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.

  PMID: 15670542 BACKGROUND

• 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.

  PMID: 18344033 BACKGROUND

• 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.

  PMID: 15713695 BACKGROUND

• 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.

  PMID: 16728877 BACKGROUND

• 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.

  PMID: 19923169 BACKGROUND

• 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.

  PMID: 19205776 BACKGROUND

• 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.

  PMID: 18617066 BACKGROUND

• 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.

  PMID: 19161878 BACKGROUND

• 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.

  PMID: 17692740 BACKGROUND

• 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.

  PMID: 18256391 BACKGROUND

• 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.

  PMID: 18559698 BACKGROUND

• 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.

  PMID: 19004841 BACKGROUND

• 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.

  PMID: 9498540 BACKGROUND

• 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.

  PMID: 26957418 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Loic BELLE, MD

  Centre Hospitalier Annecy Genevois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2011
• First Posted: May 25, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

FR (24)