COVIDAR - International Registry on Arrhythmias in COVID-19
试验速览
- 阶段
- 不适用
- 入组人数
- 10,000
- 试验地点
- 5
- 主要终点
- Arrhythmia
研究概览
简要总结
BACKGROUND AND RATIONALE: There is very limited literature available on the arrhythmia occurrence in the context of an infection by the SARS-CoV2 virus. On the other hand, treatment strategies against the SARS-CoV2 virus may carry a risk of QTc prolongation and pro-arrhythmia/sudden death which may be amplified by concomitant use of other QTc-prolonging drugs and/or ion disbalances. COVIDAR is an international initiative to monitor the occurrence of arrhythmic events in the context of the SARS-CoV2 infection, to identify potential modifiable predisposing factors to reduce their incidence and to inform the best arrhythmia management options in this patient population.
MAIN OBJECTIVE: To describe the incidence and type of arrhythmic events in the context of the SARS-CoV2 infection.
STUDY DESIGN: patient registry (observational). Patients will not undergo any additional investigations. Only data that is generated during routine clinical care will be collected.
STUDY POPULATION: Patients admitted to the hospital highly suspected of or with confirmed COVID-19.
详细描述
The COVIDAR Registry is an international longitudinal multicentre observational study worldwide which aims to assess the incidence, type and risk factors of arrhythmias in the context of SARS-CoV2 infection, also providing relevant information on events/management and major cardiovascular outcomes. During the course of the registry patients will be followed up according to the usual practice of the centres. Drug prescriptions and indications to perform diagnostic/therapeutic procedures will be completely left to the treating physicians.
The registry population will consist of patients presenting with a suspicion of SARS-CoV2 infection, who are hospitalised in a medical or surgical department of the participating hospitals. Patients will officially be enrolled in the COVIDAR Registry if the COVID-19 disease has formally been noted or confirmed in the patient's medical record.
The registry will include all patients and collect data at the following timepoints:
- Admission: evaluation before SARS-CoV2 infection treatment initiation
- On-treatment: evaluation 24-28h after treatment initiation
- At any adverse event: evaluation if any adverse event occurs
- At discharge: evaluation of clinical status at the end of the admission period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted with highly suspected/confirmed infection with SARS-CoV-2.
排除标准
- •Formal opposition by the patient to data collection.
结局指标
主要结局
Arrhythmia
时间窗: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Any arrhythmic event occurring in COVID-19 patients during hospital admission: * Monomorphic ventricular tachycardia * Polymorphic ventricular tachycardia/Torsades de pointes (non-sustained) * Ventricular fibrillation * AV-block * Severe bradycardia, symptomatic and/or requiring treatment * New-onset atrial fibrillation * Other
次要结局
- Electrocardiographic changes - Underlying rhythm(From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months)
- Electrocardiographic changes - Atrioventricular conduction(From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months)
- Electrocardiographic changes - QRS duration(From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months)
- Electrocardiographic changes - presence of Brugada QRS pattern(From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months)
- Electrocardiographic changes - QTc duration(From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months)
- Laboratory abnormalities - electrolyte misbalance(From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months)
- Laboratory abnormalities - liver function(From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months)
- Laboratory abnormalities - cardiac biomarkers(From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months)
- Laboratory abnormalities - renal function(From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months)