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Myocardial Infarction Rates Overview During COVID-19 Pandemic In France: MODIF Study (MODIF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04357314
Recruitment Status : Completed
First Posted : April 22, 2020
Last Update Posted : August 19, 2020
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
French Cardiology Society

Brief Summary:
In late December 2019, an emerging disease due to a novel coronavirus (named SARS-CoV-2) rapidly spread in China and outside. France is currently facing the COVID-19 wave with more than 131 863 confirmed cases and almost 25 201 deaths. Systems of care have been reorganized in an effort to preserve hospital bed capacity, resources, and avoid exposure of patients to the hospital environment where COVID-19 may be more prevalent. Therefore, elective procedures of catheterization and programmed hospitalizations have been delayed. However, a significant proportion of procedures within the catheterization laboratory such as ST-elevation myocardial infarction (STEMI), non ST elevation myocardial infarction or unstable angina are mandatory and cannot be postponed. Surprisingly, invasive cardiologist noticed a drop in STEMI volume without reliable data to confirm this impression. Furthermore, a recent single center report in Hong Kong pointed out longer delays of taking care when compared to patients with STEMI treated with percutaneous intervention the previous year. These data are at major concern because delay in seeking care or not seeking care could have detrimental impact on outcomes.

Condition or disease
Myocardial Infarction

Detailed Description:

The aim of this study is to investigate the rates and characteristics of patients presenting with acute myocardial infarction between march 1, 2020 to May 31, 2020 and compared those data with those of this year (march 1, 2019 to May 31, 2019).

The following elements will aslo been collected:

  • Clinical presentation
  • Mode of admission (SAMU (Service d'Aide Médicale Urgente in French ie Emergency Medical Aid Service) / emergency department / in hospital)
  • Call for SAMU : delay, number of calls, response
  • Thrombolysis
  • Delays (symptom onset to first medical contact / door to balloon)
  • Final Result : TIMI (Thrombolysis In Myocardial Infarction)
  • COVID-19 status if known
  • Underlying known ischemic cardiopathy
  • ECG (electrocardiogram) Q waves.
  • Complication after PCI (Percutaneous Coronary Intervention): Discharged date, LVEF (Left Ventricular Ejection Fraction), ventricular tachycardia Data will be collected through all participating centers under the supervision of the cath lab director.

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Study Type : Observational
Actual Enrollment : 6332 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Myocardial Infarction Rates Overview During COVID-19 Pandemic In France: MODIF Study
Actual Study Start Date : March 1, 2020
Actual Primary Completion Date : May 31, 2020
Actual Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Group/Cohort
Patients with STEMI in 2019
Patient with acute myocardial infarction between March 17, 2019 and April17, 2019
Patients with STEMI in 2020
Patient with acute myocardial infarction between March 17, 2020 and April17, 2020.



Primary Outcome Measures :
  1. The primary endpoint is a composite of death from all causes and mechanical complications of acute myocardial infarction (MI) [ Time Frame: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 ) ]
    Free wall rupture, acute ischemic mitral regurgitation, ventricular septal rupture

  2. Rates of patients presenting with acute myocardial infarction [ Time Frame: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 ) ]
    Compare the number of patients presenting to cardiology department with acute myocardial infarction in 2019 versus in 2020


Secondary Outcome Measures :
  1. Patient profile during admission for acute myocardial infarction [ Time Frame: 3 months (between March 1 to May 31 ]
    Correlation between clinical patient profile and the degree of affection of regions by COVID-19

  2. Medical care times analysis [ Time Frame: 3 months (between March 1 to May 31) ]
    Correlation between the delay between onset of symptoms - first medical contact - coronary angiography room and the degree of affection of regions by COVID-19

  3. Medical care times analysis [ Time Frame: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 ) ]
    Delay in minutes from symptom onset and STEMI (ST Segment Elevation Myocardial Infarction) diagnosis; and delay in minutes from onset of symptoms and primary PCI (percutaneous coronary intervention)

  4. Clinical evolution of patients [ Time Frame: 3 months (between March 1 to May 31) ]
    Correlation between the fate of patient and the degree of affection of regions by COVID-19: Number of days in cardiology department, Left Ventricular Ejection Fraction at discharge, presence of hemodynamic complications, presence of mechanical complications, transfer to intensive care unit, infection with COVID-19 during hospitalization, living status at discharge

  5. Clinical evolution of patients [ Time Frame: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 ) ]
    Number of in hospital outcomes including orotracheal intubation, cardiogenic shock, arrhythmias (ventricular tachycardia of ventricular fibrillation) and in hospital cardiac arrest

  6. STEMI (ST Segment Elevation Myocardial Infarction) admissions incidence rates [ Time Frame: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 ) ]
    Number of patient admitted in cardiology department with STEMI (ST Segment Elevation Myocardial Infarction)

  7. Proportion of patients who underwent systemic thrombolysis [ Time Frame: 3 months (between March 1 to May 31) ]
    Correlation between the number of patients who underwent systemic thrombolysis and the degree of affection of regions by COVID-19

  8. Proportion of patients infected with COVID-19 [ Time Frame: 3 months (between March 1 to May 31) ]
    Number of patient admitted in cardiology department for acute myocardial infarction infected with COVID-19



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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:   Probability Sample
Study Population
Patients presenting to the hospital with acute coronary syndrome
Criteria

Inclusion Criteria:

Patients admitted on coronary angiography room for acute coronary syndrome with ST segment elevation defined by the following criteria:

  • Symptoms suggestive of myocardial ischemia (ex: persistent chest pain) AND
  • An elevation of the ST segment (measured from point J) visible on at least two contiguous leads with an elevation ≥ 2.5 millimeters in men <40 years, or ≥ 2 millimeters in men ≥ 40 years, or ≥ 1.5 millimeters in women in V2-V3 leads and / or ≥ 1 millimeter in other leads (in the absence of branch block).

Exclusion Criteria:

- 121/5000

  • Contraindication to invasive management related to the general condition of the patient.
  • Minors
  • Pregnant women

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): NCT04357314


Locations
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France
Hôpital Universitaire Carémeau
Nîmes, France, 30029
Sponsors and Collaborators
French Cardiology Society
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Study Director: Guillaume CAYLA, MD Hôpital Universitaire Carémeau
Principal Investigator: Guillaume BONNET, MD Inserm 970
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Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT04357314    
Other Study ID Numbers: 2020-03
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by French Cardiology Society:
Emergency care
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases