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Myocardial Infarction With ST-Elevation (MISTRAL)

Primary Purpose

Myocardial Infarction

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Abciximab
Abciximab placebo
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Myocardial infarction, Angioplasty, Coronary stenting, Abciximab, Myocardial reperfusion, Microcirculation, EKG, ST elevation myocardial infarction within 6 h of symptom onset

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients over 18 years of age eligible for randomization in the MICU
  • Infarct within 6 hours from symptoms onset
  • Continuous typical chest pain symptoms symptoms for more than 20 min. and-ST segment elevation of more than 2 mm in more than two leads (peripheral or precordial)
  • Signed informed consent form

Exclusion Criteria:

  • Ventricular conduction anomalies masking signs of ischemia (left or right bundle branch block without evidence of additional elevation), electrical left ventricular hypertrophy
  • Known hypersensitivity to Abciximab or to any component of the product or to murine monoclonal antibodies.- Hemorrhagic diathesis, internal hemorrhage
  • Hemorrhagic stroke within 2 years
  • Ischemic stroke within the last 3 months- Intra-cranial neoplasm, intracranial malformation or arteria
  • venous aneurysm
  • Recent intracranial or intraspinal surgery or trauma (within two months)
  • Recent within (2 months) major surgery- Known peptic ulcer or upper gastrointestinal bleeding within the previous 6 month
  • Known coagulation anomaly
  • Oral anti-coagulant or low molecular weight heparin treatment- Ongoing thrombolytic treatment

Sites / Locations

  • Service de Cardiologie - Hôpital de Hautepierre - 1, Avenue Molière

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Early Abciximab bolus during prehospital transportation in ambulance 0.25 mg/Kg iv with Heparin 40 UI/kg bolus. Abciximab placebo bolus and Abciximab infusion 10 µg/Kg/min after coronary angiography and before angioplasty.

Abciximab placebo bolus during prehospital transportation in ambulance with Heparin 40 UI/kg bolus. Abciximab 0.25 mg/Kg bolus after coronary angiography and before angioplasty followed by Abciximab infusion 10 µg/Kg/min.

Outcomes

Primary Outcome Measures

ST segment regression 1 hour after angioplasty

Secondary Outcome Measures

Major cardiac events at 1 and 6 month

Full Information

First Posted
February 28, 2008
Last Updated
September 16, 2009
Sponsor
University Hospital, Strasbourg, France
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00638638
Brief Title
Myocardial Infarction With ST-Elevation
Acronym
MISTRAL
Official Title
Myocardial Infarction With ST-elevation Treated by Primary Percutaneous Intervention Facilitated by Early Reopro Administration in Alsace.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2005 (undefined)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
January 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Strasbourg, France
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Mechanical recanalization of the culprit artery in acute myocardial infarction using stents provides in 2003, TIMI 3 flow restoration in more than 90% of patients. However, the prognosis of this condition remains poor, to a large degree because of microcirculatory dysfunction that is observed, in near than 20 to 40 % of patients, during or following primary percutaneous intervention. The lack of ST-segment elevation resolution after angioplasty with stenting is a marker of microcirculatory dysfunction and is associated with a poor prognosis. Routine administration with primary stenting of the platelet glycoprotein IIb/IIIa inhibitor Abciximab in acute myocardial infarction is still a matter of debate with conflicting results emerging from two major clinical studies ADMIRAL and CADILLAC. However, evidences are in favour of a benefit of this treatment especially when administrated early (in a pre-hospital manner) before percutaneous coronary intervention.Our primary purpose is to investigate the benefit of an early (i.e. pre-hospital) vs. a conventional (i.e. per-angiography) administration of Abciximab on ST-segment elevation regression at one hour after primary percutaneous angioplasty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Myocardial infarction, Angioplasty, Coronary stenting, Abciximab, Myocardial reperfusion, Microcirculation, EKG, ST elevation myocardial infarction within 6 h of symptom onset

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
292 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Early Abciximab bolus during prehospital transportation in ambulance 0.25 mg/Kg iv with Heparin 40 UI/kg bolus. Abciximab placebo bolus and Abciximab infusion 10 µg/Kg/min after coronary angiography and before angioplasty.
Arm Title
2
Arm Type
Experimental
Arm Description
Abciximab placebo bolus during prehospital transportation in ambulance with Heparin 40 UI/kg bolus. Abciximab 0.25 mg/Kg bolus after coronary angiography and before angioplasty followed by Abciximab infusion 10 µg/Kg/min.
Intervention Type
Drug
Intervention Name(s)
Abciximab
Other Intervention Name(s)
1: Experimental, 2: Experimental
Intervention Description
Abciximab: 0.25 mg/Kg bolus Abciximab placebo bolus Abciximab infusion 10 µg/Kg/min
Intervention Type
Drug
Intervention Name(s)
Abciximab placebo
Other Intervention Name(s)
1: Experimental, 2: Experimental
Intervention Description
Abciximab placebo Bolus Abciximab: 0.25 mg/Kg bolus Abciximab infusion 10 µg/Kg/min
Primary Outcome Measure Information:
Title
ST segment regression 1 hour after angioplasty
Time Frame
1 hour after angioplasty
Secondary Outcome Measure Information:
Title
Major cardiac events at 1 and 6 month
Time Frame
1 and 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over 18 years of age eligible for randomization in the MICU Infarct within 6 hours from symptoms onset Continuous typical chest pain symptoms symptoms for more than 20 min. and-ST segment elevation of more than 2 mm in more than two leads (peripheral or precordial) Signed informed consent form Exclusion Criteria: Ventricular conduction anomalies masking signs of ischemia (left or right bundle branch block without evidence of additional elevation), electrical left ventricular hypertrophy Known hypersensitivity to Abciximab or to any component of the product or to murine monoclonal antibodies.- Hemorrhagic diathesis, internal hemorrhage Hemorrhagic stroke within 2 years Ischemic stroke within the last 3 months- Intra-cranial neoplasm, intracranial malformation or arteria venous aneurysm Recent intracranial or intraspinal surgery or trauma (within two months) Recent within (2 months) major surgery- Known peptic ulcer or upper gastrointestinal bleeding within the previous 6 month Known coagulation anomaly Oral anti-coagulant or low molecular weight heparin treatment- Ongoing thrombolytic treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick OHLMANN, MD, PhD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Cardiologie - Hôpital de Hautepierre - 1, Avenue Molière
City
Strasbourg
ZIP/Postal Code
67 098
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22319064
Citation
Ohlmann P, Reydel P, Jacquemin L, Adnet F, Wolf O, Bartier JC, Weiss A, Lapostolle F, Gaultier C, Salengro E, Benamer H, Guyon P, Chevalier B, Catan S, Ecollan P, Chouihed T, Angioi M, Zupan M, Bronner F, Bareiss P, Steg G, Montalescot G, Monassier JP, Morel O. Prehospital abciximab in ST-segment elevation myocardial infarction: results of the randomized, double-blind MISTRAL study. Circ Cardiovasc Interv. 2012 Feb 1;5(1):69-76, S1. doi: 10.1161/CIRCINTERVENTIONS.111.961425. Epub 2012 Feb 7.
Results Reference
derived

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Myocardial Infarction With ST-Elevation

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