Myocardial Infarction Rates Overview During COVID-19 Pandemic In France: MODIF Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6,332
- 试验地点
- 1
- 主要终点
- The primary endpoint is a composite of death from all causes and mechanical complications of acute myocardial infarction (MI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Contraindication to invasive management related to the general condition of the patient.
- •Pregnant women
结局指标
主要结局
The primary endpoint is a composite of death from all causes and mechanical complications of acute myocardial infarction (MI)
时间窗: 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 infarction
时间窗: 3 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
次要结局
- Proportion of patients infected with COVID-19(3 months (between March 1 to May 31))
- Patient profile during admission for acute myocardial infarction(3 months (between March 1 to May 31)
- STEMI (ST Segment Elevation Myocardial Infarction) admissions incidence rates(3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 ))
- Proportion of patients who underwent systemic thrombolysis(3 months (between March 1 to May 31))
- Clinical evolution of patients(3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 ))
- Medical care times analysis(3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 ))