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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04357314
Acronym
MODIF
Enrollment
6332
Registered
2020-04-22
Start date
2020-03-01
Completion date
2020-05-31
Last updated
2020-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

Emergency care

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.

Interventions

None listed

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
French Cardiology Society
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The primary endpoint is a composite of death from all causes and mechanical complications of acute myocardial infarction (MI)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
Rates of patients presenting with acute myocardial infarction3 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

MeasureTime frameDescription
Medical care times analysis3 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
STEMI (ST Segment Elevation Myocardial Infarction) admissions incidence rates3 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)
Clinical evolution of patients3 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
Proportion of patients infected with COVID-193 months (between March 1 to May 31)Number of patient admitted in cardiology department for acute myocardial infarction infected with COVID-19
Proportion of patients who underwent systemic thrombolysis3 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
Patient profile during admission for acute myocardial infarction3 months (between March 1 to May 31Correlation between clinical patient profile and the degree of affection of regions by COVID-19

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026