Clinical trial NCT04357314: Myocardial Infarction Rates Overview During COVID-19 Pandemic In France: MODIF Study
Official title: Myocardial Infarction Rates Overview During COVID-19 Pandemic In France: MODIF Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Keywords: Emergency care
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2020-04-22
Enrollment: 6332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting to the hospital with acute coronary syndrome

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.

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.

Eligibility 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

Primary outcomes:
measure: The primary endpoint is a composite of death from all causes and mechanical complications of acute myocardial infarction (MI)
timeFrame: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )
measure: Rates of patients presenting with acute myocardial infarction
timeFrame: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )
Secondary outcomes:
measure: Patient profile during admission for acute myocardial infarction
timeFrame: 3 months (between March 1 to May 31
measure: Medical care times analysis
timeFrame: 3 months (between March 1 to May 31)
measure: Medical care times analysis
timeFrame: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )
measure: Clinical evolution of patients
timeFrame: 3 months (between March 1 to May 31)
measure: Clinical evolution of patients
timeFrame: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )
measure: STEMI (ST Segment Elevation Myocardial Infarction) admissions incidence rates
timeFrame: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )
measure: Proportion of patients who underwent systemic thrombolysis
timeFrame: 3 months (between March 1 to May 31)
measure: Proportion of patients infected with COVID-19
timeFrame: 3 months (between March 1 to May 31)
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Hôpital Universitaire Carémeau
Study officials:
affiliation: Hôpital Universitaire Carémeau
name: Guillaume CAYLA, MD
role: STUDY_DIRECTOR
affiliation: Inserm 970
name: Guillaume BONNET, MD
role: PRINCIPAL_INVESTIGATOR
References: