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

NCT ID: NCT04357314

Last Updated: 2020-08-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6332 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2020-05-31

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.

Conditions

Myocardial Infarction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with STEMI in 2019

Patient with acute myocardial infarction between March 17, 2019 and April17, 2019

No interventions assigned to this group

Patients with STEMI in 2020

Patient with acute myocardial infarction between March 17, 2020 and April17, 2020.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

French Cardiology Society

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume CAYLA, MD

Role: STUDY_DIRECTOR

Hôpital Universitaire Carémeau

Guillaume BONNET, MD

Role: PRINCIPAL_INVESTIGATOR

Inserm 970

Locations

Hôpital Universitaire Carémeau

Nîmes, , France

Countries

France

Other Identifiers

2020-03

Identifier Type: -

Identifier Source: org_study_id