Clinical Presentation and Outcomes in Patients at Risk of Type II Myocardial InfarctioN in the emerGency Department.

Completed

• Conditions: Myocardial Infarction; Myocardial Oxygenation Imbalance
• Interventions: Other: Follow-up

• Registration Number: NCT03953651
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Type 2 myocardial infarction has been reported in the Universal Definition of Myocardial Infarction for more than 10 years and most studies resulted in a high mortality rate. However, little to nothing is known for both criteria to define myocardial oxygenation imbalance threshold and the outcome of these patients presenting with myocardial oxygenation imbalance.

The aim of this study is to compare the outcome at 6 months for patients admitted in the emergency department with a myocardial oxygenation imbalance, depending on whether a type 2 myocardial infarction occured or not.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-15
• Study First Posted: 2019-05-16
• Study Start: 2019-07-10
• Status Verified: 2020-07
• Primary Completion: 2020-07-09
• Study Completion: 2020-07-09
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• age 18 years old or older ;

• At least one condition of myocardial oxygenation imbalance :

  • Oxygen saturation below 90% ;
  • Haemoglobin level below 130 grams/Liter (g/L) for men, 120 g/L for women ;
  • Persistent heart rate over 110 beats per minute, for more than 20 minutes ;
  • Persistent systolic blood pressure below 90 millimeters of mercury (mmHg) for more than 20 minutes despite fluid resuscitation ;
  • Persistent systolic blood pressure over 180 mmHg for more than 20 minutes.

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Exclusion Criteria

• Patient admitted with type 1 myocardial infarction ;
• Patient presenting a condition for Non Ischemic Myocardial Infarction (pulmonary embolism, acute stroke, acute kidney failure, etc...)
• Patient who declines to participate;
• Pregnant or breastfeeding women ;
• Patient deprived of liberty (inmate, administrative protection)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Follow-up	Patients admitted in the emergency department presenting a myocardial oxygenation imbalance and are therefore at risk for Myocardial Infarction (MI) type 2.

Primary Outcome Measures

Name	Time	Method
Onset of a Major Adverse Cardiovascular Event at 6 months	6 months	Onset of a Major Adverse Cardiovascular Event such as: * Cardiovascular death; * Non fatal myocardial infarction; * Admission for acute heart failure; * Non fatal stroke

Trial Locations

Locations (1)

Hôpital Edouard Herriot; 🇫🇷 Lyon, France