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

Myocardial Infarction Clinical Trial

— MODIF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04357314
• Other study ID #: 2020-03
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: May 31, 2020

Study information

• Verified date: August 2020
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6332
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
France	Hôpital Universitaire Carémeau	Nîmes

Sponsors (2)

Lead Sponsor	Collaborator
French Cardiology Society	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 )
Primary	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	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
Secondary	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)
Secondary	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 )
Secondary	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)
Secondary	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 )
Secondary	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 )
Secondary	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)
Secondary	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)