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

NCT03953651 | Completed

• 2 other identifiers: 69HCL18_09132019-A00177-50
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients

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

Other: Follow-up

Interventions

Follow-up OTHER

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

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male or female patients at least 18 years old admitted to the emergency department with a myocardial oxygenation imbalance

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Edouard Herriot

Lyon, 69003, France

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Laurent JACQUIN, Dr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 16, 2019
• Study Start: July 10, 2019
• Primary Completion: July 9, 2020
• Study Completion: July 9, 2020
• Last Updated: July 28, 2020

Record last verified: 2020-07

Locations

FR (1)