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

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ClinicalTrials.gov Identifier: NCT03953651
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Myocardial Oxygenation Imbalance Myocardial Infarction Other: Follow-up

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Presentation and Outcomes in Patients at Risk of Type II Myocardial InfarctioN in the emerGency Department.
Estimated Study Start Date : May 31, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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




Primary Outcome Measures :
  1. Onset of a Major Adverse Cardiovascular Event at 6 months [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953651


Contacts
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Contact: Laurent JACQUIN, Dr 4 72 11 69 47 ext 33 EH_recherche_urgences@chu-lyon.fr

Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Laurent JACQUIN, Dr Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03953651     History of Changes
Other Study ID Numbers: 69HCL18_0913
2019-A00177-50 ( Other Identifier: ID-RCB )
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
Emergencies
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Disease Attributes