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

Myocardial Infarction Clinical Trial

— COMING  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03953651
• Other study ID #: 69HCL18_0913
• Secondary ID: 2019-A00177-50
• Status: Completed
• Start date: July 10, 2019
• Est. completion date: July 9, 2020

Study information

• Verified date: July 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: July 9, 2020
• Est. primary completion date: July 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Emergencies
• Infarction
• Myocardial Infarction
• Myocardial Oxygenation Imbalance

Intervention

Other:
• Follow-up
Onset of Major Adverse Cardiovascular Event of death from all causes will be collected at 3 and 6 months after inclusion.

Locations

Country	Name	City	State
France	Hôpital Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset of a Major Adverse Cardiovascular Event at 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	6 months