Effect of METOprolol in CARDioproteCtioN During an Acute Myocardial InfarCtion. The METOCARD-CNIC Trial. (METOCARD-CNIC)
|ClinicalTrials.gov Identifier: NCT01311700|
Recruitment Status : Completed
First Posted : March 9, 2011
Last Update Posted : December 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction||Drug: Injectable (i.v.) metoprolol tartrate (up to 15 mg).||Phase 4|
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.
ß-blockers are a class of drugs that have been used to treat cardiovascular conditions for several decades. β-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 β-blocker administration gives the maximum cardioprotective effect. In particular, whether early β-blocker administration is able to reduce infarct size is a subject of debate. Recent experimental data suggest that the β1 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||221 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||November 2010|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2017|
|Active Comparator: Early metoprolol initiation strategy||
Drug: Injectable (i.v.) metoprolol tartrate (up to 15 mg).
Patients are randomized to active intervention (early metoprolol initiation strategy) or no treatment (delayed metoprolol initiation strategy).
Patients randomized to early metoprolol initiation strategy receive up to three 5mg i.v. dosages (2 minutes apart) before reperfusion.
Patients randomized to delayed metoprolol initiation strategy receive no active treatment before reperfusion.
Patients in both groups receive oral metoprolol tartrate treatment (25-100mg/12h), starting 12-24 hr post-reperfusion.
|No Intervention: Delayed metoprolol initiation strategy|
- Infarct size evaluated primarily by area of delayed enhancement on cardiac magnetic resonance imaging. [ Time Frame: 5-7 days after reperfusion ]
- Infarct size evaluated primarily by the area under the curve of CK, CK-MB and troponin release over the first 72 hours of reperfusion. [ Time Frame: over the first 72 hours of reperfusion. ]
- Infarct size evaluated by area of delayed enhancement on cardiac magnetic resonance imaging. [ Time Frame: at month 6 ]
- 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. [ Time Frame: 5-7 days after reperfusion. ]
- Percent salvaged myocardium evaluated by cardiac magnetic resonance imaging. [ Time Frame: 5-7 days after reperfusion ]
- Recovery of myocardial contraction assessed by magnetic resonance imaging and echocardiography. [ Time Frame: at month 6 ]
- Myocardial perfusion evaluated by magnetic resonance imaging. [ Time Frame: 5-7 days post-reperfusion. ]
- Composite of death, malignant ventricular arrhythmias, reinfarction or admission due to heart failure [ Time Frame: hospital discharge, 1, 6 and 12 months post-reperfusion. ]
- Major cardiovascular events (death, malignant ventricular arrhythmias, AV block, cardiogenic shock, reinfarction). [ Time Frame: within first 24 hr post-reperfusion. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01311700
|Hospital Marqués de Valdecilla|
|Santander, Cantabria, Spain, 39008|
|Hospital Puerta de Hierro|
|Majadahonda, Madrid, Spain, 28013|
|Hospital Universitario de Vigo-Hospital Meixoeiro|
|Vigo, Pontevedra, Spain, 36200|
|Servicio de Urgencias Sanitarias 061 de Galicia|
|Vigo, Pontevedra, Spain, 36204|
|Hospital de León|
|León, Spain, 24008|
|Hospital La Princesa|
|Madrid, Spain, 28006|
|Servicio de Asistencia Municipal de Urgencia y Rescate (SAMUR)|
|Madrid, Spain, 28011|
|• Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC),|
|Madrid, Spain, 28029|
|Hospital Clínico San Carlos|
|Madrid, Spain, 28040|
|Hospital 12 de Octubre|
|Madrid, Spain, 28041|
|Servicio de Urgencia Médica de la Comunidad de Madrid (SUMMA) 112|
|Madrid, Spain, 28045|
|Hospital Universitario Quirón|
|Madrid, Spain, 28223|
|Principal Investigator:||Borja Ibanez, MD PhD||CNIC|