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

NCT ID: NCT03953651

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-10
• Study Completion Date: 2020-07-09

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.

Conditions

Myocardial Oxygenation Imbalance; Myocardial Infarction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

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

Follow-up

Intervention Type: OTHER

Onset of Major Adverse Cardiovascular Event of death from all causes will be collected at 3 and 6 months after inclusion.

Interventions

Follow-up

Onset of Major Adverse Cardiovascular Event of death from all causes will be collected at 3 and 6 months after inclusion.

Intervention Type: OTHER

Eligibility Criteria

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.

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent JACQUIN, Dr

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Hôpital Edouard Herriot

Lyon, , France

Countries

France

Other Identifiers

2019-A00177-50

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL18_0913

Identifier Type: -

Identifier Source: org_study_id