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

June 15, 2018 updated by: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

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

Enrollment (Actual)

221

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • León, Spain, 24008
        • Hospital de Leon
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Madrid, Spain, 28006
        • Hospital La Princesa
      • Madrid, Spain, 28011
        • Servicio de Asistencia Municipal de Urgencia y Rescate (SAMUR)
      • Madrid, Spain, 28029
        • • Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC),
      • Madrid, Spain, 28045
        • Servicio de Urgencia Médica de la Comunidad de Madrid (SUMMA) 112
      • Madrid, Spain, 28223
        • Hospital Universitario Quirón
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Marques de Valdecilla
    • Madrid
      • Majadahonda, Madrid, Spain, 28013
        • Hospital Puerta de Hierro
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36200
        • Hospital Universitario de Vigo-Hospital Meixoeiro
      • Vigo, Pontevedra, Spain, 36204
        • Servicio de Urgencias Sanitarias 061 de Galicia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infarct size evaluated primarily by area of delayed enhancement on cardiac magnetic resonance imaging.
Time Frame: 5-7 days after reperfusion
5-7 days after reperfusion

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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
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.
5-7 days after reperfusion.
Percent salvaged myocardium evaluated by cardiac magnetic resonance imaging.
Time Frame: 5-7 days after reperfusion
5-7 days after reperfusion
Recovery of myocardial contraction assessed by magnetic resonance imaging and echocardiography.
Time Frame: at month 6
at month 6
Myocardial perfusion evaluated by magnetic resonance imaging.
Time Frame: 5-7 days post-reperfusion.
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.
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.
within first 24 hr post-reperfusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Collaborators

Fundación Mutua Madrileña
Ministerio de Sanidad, Servicios Sociales e Igualdad

Investigators

  • Principal Investigator: Borja Ibanez, MD PhD, CNIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

March 8, 2011

First Submitted That Met QC Criteria

March 8, 2011

First Posted (Estimate)

March 9, 2011

Study Record Updates

Last Update Posted (Actual)

June 18, 2018

Last Update Submitted That Met QC Criteria

June 15, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METOCARD-CNIC
  • CNIC translational Grant 2009 (Other Grant/Funding Number: CNIC translational Grant 2009 (Exp# 01-2009))
  • 2010-019939-35 (EudraCT Number)
  • Ministerio de Sanidad (Other Grant/Funding Number: Ministerio de Sanidad, Política Social e Igualdad Grant (EC10-042).)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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