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出境医 / 临床实验 / Clinical Presentation and Outcomes in Patients at Risk of Type II Myocardial InfarctioN in the emerGency Department. (COMING)

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

Study Description
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

Study Design
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Study Type : Observational
Actual 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.
Actual Study Start Date : July 10, 2019
Actual Primary Completion Date : July 9, 2020
Actual Study Completion Date : July 9, 2020
Arms and Interventions
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.
Outcome Measures
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


Eligibility Criteria
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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)
Contacts and Locations

Locations
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France
Hôpital Edouard Herriot
Lyon, France, 69003
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Laurent JACQUIN, Dr Hospices Civils de Lyon
Tracking Information
First Submitted Date May 15, 2019
First Posted Date May 16, 2019
Last Update Posted Date July 28, 2020
Actual Study Start Date July 10, 2019
Actual Primary Completion Date July 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 15, 2019) 		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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Presentation and Outcomes in Patients at Risk of Type II Myocardial InfarctioN in the emerGency Department.
Official Title Clinical Presentation and Outcomes in Patients at Risk of Type II Myocardial InfarctioN in the emerGency Department.
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Myocardial Oxygenation Imbalance
  • Myocardial Infarction
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.
Study Groups/Cohorts Patients
Patients admitted in the emergency department presenting a myocardial oxygenation imbalance and are therefore at risk for Myocardial Infarction (MI) type 2.
Intervention: Other: Follow-up
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 15, 2019) 		1000
Original Estimated Enrollment Same as current
Actual Study Completion Date July 9, 2020
Actual Primary Completion Date July 9, 2020   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03953651
Other Study ID Numbers 69HCL18_0913
2019-A00177-50 ( Other Identifier: ID-RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators
Principal Investigator: Laurent JACQUIN, Dr Hospices Civils de Lyon
PRS Account Hospices Civils de Lyon
Verification Date July 2020

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