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

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Status and phase: Completed; Phase 4

Conditions: Myocardial Infarction

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01311700

Ministerio de Sanidad (Other Grant/Funding Number)

2010-019939-35 (EudraCT Number)

METOCARD-CNIC

CNIC translational Grant 2009 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

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.

Enrollment: 221 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Confirmed* acute anterior wall myocardial infarction (ST segment elevation ≥ 2mm in ≥ 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 (PR˃240 mS or superior) on diagnosis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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221 participants in 2 patient groups

Early metoprolol initiation strategy

Active Comparator group

Treatment:

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

Delayed metoprolol initiation strategy

No Intervention group