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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Ministerio de Sanidad, Política Social e Igualdad Grant (EC10-042).
Fundacion Mutua Madrileña (AP8695-2011)
Information provided by (Responsible Party):
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
ClinicalTrials.gov Identifier:
NCT01311700
First received: March 8, 2011
Last updated: February 12, 2013
Last verified: February 2013

March 8, 2011
February 12, 2013
November 2010
October 2012   (final data collection date for primary outcome measure)
Infarct size evaluated primarily by area of delayed enhancement on cardiac magnetic resonance imaging. [ Time Frame: 5-7 days after reperfusion ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01311700 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
  • Infarct size evaluated by area of delayed enhancement on cardiac magnetic resonance imaging. [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Percent salvaged myocardium evaluated by cardiac magnetic resonance imaging. [ Time Frame: 5-7 days after reperfusion ] [ Designated as safety issue: No ]
  • Recovery of myocardial contraction assessed by magnetic resonance imaging and echocardiography. [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
  • Myocardial perfusion evaluated by magnetic resonance imaging. [ Time Frame: 5-7 days post-reperfusion. ] [ Designated as safety issue: No ]
  • Composite of death, malignant ventricular arrhythmias, reinfarction or admission due to heart failure [ Time Frame: hospital discharge, 1, 6 and 12 months post-reperfusion. ] [ Designated as safety issue: No ]
  • Major cardiovascular events (death, malignant ventricular arrhythmias, AV block, cardiogenic shock, reinfarction). [ Time Frame: within first 24 hr post-reperfusion. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: No ]
  • Infarct size evaluated by area of delayed enhancement on cardiac magnetic resonance imaging. [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Percent salvaged myocardium evaluated by cardiac magnetic resonance imaging. [ Time Frame: 5-7 days after reperfusion ] [ Designated as safety issue: No ]
  • Recovery of myocardial contraction assessed by magnetic resonance imaging and echocardiography. [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
  • Myocardial perfusion evaluated by magnetic resonance imaging. [ Time Frame: 5-7 days post-reperfusion. ] [ Designated as safety issue: No ]
  • Composite of death, malignant ventricular arrhythmias, reinfarction or cardiovascular readmission [ Time Frame: hospital discharge, 1, 6 and 12 months post-reperfusion. ] [ Designated as safety issue: No ]
  • Major cardiovascular events (death, malignant ventricular arrhythmias, AV block, cardiogenic shock, reinfarction). [ Time Frame: within first 24 hr post-reperfusion. ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Effect of METOprolol in CARDioproteCtioN During an Acute Myocardial InfarCtion. The METOCARD-CNIC Trial.
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.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Myocardial Infarction.
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.

  • Active Comparator: Early metoprolol initiation strategy
    Intervention: Drug: Injectable (i.v.) metoprolol tartrate (up to 15 mg).
  • No Intervention: Delayed metoprolol initiation strategy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
221
October 2013
October 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01311700
METOCARD-CNIC, CNIC translational Grant 2009, 2010-019939-35, Ministerio de Sanidad
Yes
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
  • Ministerio de Sanidad, Política Social e Igualdad Grant (EC10-042).
  • Fundacion Mutua Madrileña (AP8695-2011)
Principal Investigator: Borja Ibanez, MD PhD CNIC
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP