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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 6332

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients presenting to the hospital with acute coronary syndrome

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary endpoint is a composite of death from all causes and mechanical complications of acute myocardial infarction (MI)	Free wall rupture, acute ischemic mitral regurgitation, ventricular septal rupture	3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )
Rates of patients presenting with acute myocardial infarction	Compare the number of patients presenting to cardiology department with acute myocardial infarction in 2019 versus in 2020	3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient profile during admission for acute myocardial infarction	Correlation between clinical patient profile and the degree of affection of regions by COVID-19	3 months (between March 1 to May 31
Medical care times analysis	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 months (between March 1 to May 31)
Medical care times analysis	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)	3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )
Clinical evolution of patients	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	3 months (between March 1 to May 31)
Clinical evolution of patients	Number of in hospital outcomes including orotracheal intubation, cardiogenic shock, arrhythmias (ventricular tachycardia of ventricular fibrillation) and in hospital cardiac arrest	3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )
STEMI (ST Segment Elevation Myocardial Infarction) admissions incidence rates	Number of patient admitted in cardiology department with STEMI (ST Segment Elevation Myocardial Infarction)	3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )
Proportion of patients who underwent systemic thrombolysis	Correlation between the number of patients who underwent systemic thrombolysis and the degree of affection of regions by COVID-19	3 months (between March 1 to May 31)
Proportion of patients infected with COVID-19	Number of patient admitted in cardiology department for acute myocardial infarction infected with COVID-19	3 months (between March 1 to May 31)

Collaborators and Investigators

• Sponsor: French Cardiology Society
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Study Director: Guillaume CAYLA, MD, Hopital Universitaire Caremeau; Principal Investigator: Guillaume BONNET, MD, Inserm 970

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2020
• Primary Completion (ACTUAL): May 31, 2020
• Study Completion (ACTUAL): May 31, 2020

Study Registration Dates

• First Submitted: April 19, 2020
• First Submitted That Met QC Criteria: April 19, 2020
• First Posted (ACTUAL): April 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 17, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Emergency care
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Myocardial Infarction; Infarction; COVID-19
• Other Study ID Numbers: 2020-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No