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Effect of METOprolol in CARDioproteCtioN During an Acute Myocardial InfarCtion. The METOCARD-CNIC Trial.

Information source: Fundaciůn Centro Nacional de Investigaciones Cardiovasculares Carlos III
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myocardial Infarction.

Intervention: Injectable (i.v.) metoprolol tartrate (up to 15 mg). (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Fundaciůn Centro Nacional de Investigaciones Cardiovasculares Carlos III

Official(s) and/or principal investigator(s):
Borja Ibanez, MD PhD, Principal Investigator, Affiliation: CNIC

Summary

The purpose of this study is to test whether early pre-reperfusion metoprolol administration in patients suffering and acute myocardial infarction might reduce the size of myocardial necrosis.

Clinical Details

Official title: Effect of METOprolol in CARDioproteCtioN During an Acute Myocardial InfarCtion. The ME"Effect of METOprolol in CARDioproteCtioN During an Acute Myocardial InfarCtion" (METOCARD-CNIC): A Randomized, Controlled Parallel-group, Observer-blinded Clinical Trial of Early Pre-reperfusion Metoprolol Administration in ST-segment Elevation Myocardial infarctionTOCARD-CNIC Trial.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Infarct size evaluated primarily by area of delayed enhancement on cardiac magnetic resonance imaging.

Secondary outcome:

Infarct size evaluated primarily by the area under the curve of CK, CK-MB and troponin release over the first 72 hours of reperfusion.

Infarct size evaluated by area of delayed enhancement on cardiac magnetic resonance imaging.

Infarct size evaluated by area of delayed enhancement on cardiac magnetic resonance imaging in patients with coronary TIMI flow 0-1 of culprit coronary artery.

Percent salvaged myocardium evaluated by cardiac magnetic resonance imaging.

Recovery of myocardial contraction assessed by magnetic resonance imaging and echocardiography.

Myocardial perfusion evaluated by magnetic resonance imaging.

Composite of death, malignant ventricular arrhythmias, reinfarction or admission due to heart failure

Major cardiovascular events (death, malignant ventricular arrhythmias, AV block, cardiogenic shock, reinfarction).

Detailed description: Acute myocardial infarction (AMI) is a chief cause of death worldwide. The best strategy to limit myocardial damage is to perform an early coronary reperfusion. However, despite reperfusion, the size of infarctions is many times large. Infarct size has been recently shown to be a strong predictor of future cardiovascular events and mortality. Therefore interventions aimed at reducing infarct size are the matter of intense research; but despite great efforts, no therapy has been shown to consistently limit infarct size. √ü-blockers are a class of drugs that have been used to treat cardiovascular conditions for several decades. ő≤-blockers reduce mortality when administered after an AMI, and are a class IA indication in this context. What remains unclear is what timing and route of ő≤-blocker administration gives the maximum cardioprotective effect. In particular, whether early ő≤-blocker administration is able to reduce infarct size is a subject of debate. Recent experimental data suggest that the ő≤1 selective blocker metoprolol is able to limit the area of necrosis only when administered before reperfusion. The objective of this trial is to determine whether the administration of intravenous pre-reperfusion metoprolol might reduce infarct size.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Confirmed* acute anterior wall myocardial infarction (ST segment elevation ‚Č• 2mm in ‚Č• 2 contiguous leads [one of which should be V2, V3, or V4]). 2. Killip class I or II on diagnosis.

- Cases of non-confirmed infarction by enzymatic release (above 2 standard

deviations from upper limit of CK and Troponin) are excluded from efficacy analysis but kept in the safety analysis. Exclusion Criteria: 1. COPD or asthma on active bronchodilator therapy 2. Active treatment with beta blockers 3. Left bundle branch block or pacemaker. 4. Systolic blood pressure <120 mmHg, Heart rate <60 bpm, or AV block (PRňÉ240 mS or superior) on diagnosis.

Locations and Contacts

Hospital de León, León 24008, Spain

Hospital 12 de Octubre, Madrid 28041, Spain

Hospital Clínico San Carlos, Madrid 28040, Spain

Hospital La Princesa, Madrid 28006, Spain

Hospital Universitario Quirón, Madrid 28223, Spain

Servicio de Asistencia Municipal de Urgencia y Rescate (SAMUR), Madrid 28011, Spain

Servicio de Urgencia Médica de la Comunidad de Madrid (SUMMA) 112, Madrid 28045, Spain

‚ÄĘ Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC),, Madrid 28029, Spain

Hospital Marqués de Valdecilla, Santander, Cantabria 39008, Spain

Hospital Puerta de Hierro, Majadahonda, Madrid 28013, Spain

Hospital Universitario de Vigo-Hospital Meixoeiro, Vigo, Pontevedra 36200, Spain

Servicio de Urgencias Sanitarias 061 de Galicia, Vigo, Pontevedra 36204, Spain

Additional Information

Official Study Website

Related publications:

Ibanez B, Prat-González S, Speidl WS, Vilahur G, Pinero A, Cimmino G, García MJ, Fuster V, Sanz J, Badimon JJ. Early metoprolol administration before coronary reperfusion results in increased myocardial salvage: analysis of ischemic myocardium at risk using cardiac magnetic resonance. Circulation. 2007 Jun 12;115(23):2909-16. Epub 2007 May 21.

Ibanez B, Cimmino G, Prat-González S, Vilahur G, Hutter R, García MJ, Fuster V, Sanz J, Badimon L, Badimon JJ. The cardioprotection granted by metoprolol is restricted to its administration prior to coronary reperfusion. Int J Cardiol. 2011 Mar 17;147(3):428-32. doi: 10.1016/j.ijcard.2009.09.551. Epub 2009 Nov 12.

Sharma SK, Kini A, Marmur JD, Fuster V. Cardioprotective effect of prior beta-blocker therapy in reducing creatine kinase-MB elevation after coronary intervention: benefit is extended to improvement in intermediate-term survival. Circulation. 2000 Jul 11;102(2):166-72.

Halkin A, Grines CL, Cox DA, Garcia E, Mehran R, Tcheng JE, Griffin JJ, Guagliumi G, Brodie B, Turco M, Rutherford BD, Aymong E, Lansky AJ, Stone GW. Impact of intravenous beta-blockade before primary angioplasty on survival in patients undergoing mechanical reperfusion therapy for acute myocardial infarction. J Am Coll Cardiol. 2004 May 19;43(10):1780-7.

Harjai KJ, Stone GW, Boura J, Grines L, Garcia E, Brodie B, Cox D, O'Neill WW, Grines C. Effects of prior beta-blocker therapy on clinical outcomes after primary coronary angioplasty for acute myocardial infarction. Am J Cardiol. 2003 Mar 15;91(6):655-60.

Larose E, Rod√©s-Cabau J, Pibarot P, Rinfret S, Proulx G, Nguyen CM, D√©ry JP, Gleeton O, Roy L, No√ęl B, Barbeau G, Rouleau J, Boudreault JR, Amyot M, De Larochelli√®re R, Bertrand OF. Predicting late myocardial recovery and outcomes in the early hours of ST-segment elevation myocardial infarction traditional measures compared with microvascular obstruction, salvaged myocardium, and necrosis characteristics by cardiovascular magnetic resonance. J Am Coll Cardiol. 2010 Jun 1;55(22):2459-69. doi: 10.1016/j.jacc.2010.02.033.

Raman SV, Simonetti OP, Winner MW 3rd, Dickerson JA, He X, Mazzaferri EL Jr, Ambrosio G. Cardiac magnetic resonance with edema imaging identifies myocardium at risk and predicts worse outcome in patients with non-ST-segment elevation acute coronary syndrome. J Am Coll Cardiol. 2010 Jun 1;55(22):2480-8. doi: 10.1016/j.jacc.2010.01.047.

Ibanez B, Fuster V, Macaya C, S√°nchez-Brunete V, Pizarro G, L√≥pez-Romero P, Mateos A, Jim√©nez-Borreguero J, Fern√°ndez-Ortiz A, Sanz G, Fern√°ndez-Friera L, Corral E, Barreiro MV, Ruiz-Mateos B, Goicolea J, Hern√°ndez-Antol√≠n R, Acebal C, Garc√≠a-Rubira JC, Albarr√°n A, Zamorano JL, Casado I, Valenciano J, Fern√°ndez-V√°zquez F, de la Torre JM, P√©rez de Prado A, Iglesias-V√°zquez JA, Mart√≠nez-Tenorio P, I√Īiguez A. Study design for the "effect of METOprolol in CARDioproteCtioN during an acute myocardial InfarCtion" (METOCARD-CNIC): a randomized, controlled parallel-group, observer-blinded clinical trial of early pre-reperfusion metoprolol administration in ST-segment elevation myocardial infarction. Am Heart J. 2012 Oct;164(4):473-480.e5. doi: 10.1016/j.ahj.2012.07.020.

Starting date: November 2010
Last updated: February 12, 2013

Page last updated: August 23, 2015

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