International Survey of Acute Coronavirus Syndromes (ISACS)-COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 3
- 主要终点
- Death all cause
研究概览
简要总结
In response to the COVID-19 crisis, ISACS-TC has promoted a new registry of the existing and further centers of the same geographic areas to support clinical research to prevent, and treat the COVID-19 illness. These efforts are made possible by the generous contributions of clinical research volunteers in some of the countries participating to the prior acute coronary syndrome network.
详细描述
To address existing gaps in knowledge on CVD among European countries at different income levels, a collaboration of outcomes-oriented researchers from the University of Bologna partnered with Central and East European (CEE) countries researchers to conduct the International Survey of Acute Coronary Syndromes in Transitional Countries (ISACS-TC) investigating underlying threats in patients' CVD health status (NCT01218776).
In response to the COVID-19 crisis, ISACS-TC has promoted a new registry of the existing and further centers of the same geographic areas to support clinical research to prevent, and treat the COVID-19 illness. These efforts are made possible by the generous contributions of clinical research volunteers in some of the countries participating to the prior acute coronary syndrome network.
Scientific and clinical evidence is evolving on the effects of COVID-19, which can affect multiple organ systems. As, so the COVID-19 pandemic underscores the urgent need for coordination, collaboration, and information-sharing among researchers worldwide. Researchers of many disciplines have, therefore, joined the ISACS-TC investigators to build a multi-disciplinary registry investigating the impact of COVID-19.
Projects should be mainly focused on topics related to:
- The impact of COVID-19 infection on patients who have attended any health care center (within hospital beds), and who have been discharged or have died at the time of the evaluation. The main objective of this task is to carefully characterize the clinical profile of patients infected with COVID-19 in order to develop a simple prognostic clinical score allowing rapid logistic decision making such as discharge with follow-up, referral to provisional hospitals, or admission to hospital centers with advanced equipment or specialized procedures and techniques. A secondary objective of this retrospective analysis is to evaluate the risk-adjusted influence of prior evidence-based treatments and comorbidities on patients infected with the disease.
- The second issue relates to the long-term health consequences after COVID-19 infection. Early reports suggest residual effects of SARS-CoV-2 infection, such as fatigue, dyspnea, chest pain, cognitive disturbances, arthralgia, and decline in quality of life. However, the evidence is still scarce. Prior studies did not take into account the vast majority of patients with a mild course of the infection. As well, the definition of the post-acute COVID-19 timeline is evolving. Today we may summarize the post-acute COVID-19 syndrome into two categories:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Age ≥18 years (male or female)
- •Patients admitted to any hospital center with a confirmed diagnosis of COVID-19 infection.
排除标准
- •Underage or not able to give informed consent
研究组 & 干预措施
Smoking
Non-interventional patient registry
干预措施: Observational (registry) (Combination Product)
Kidney Disease
Non-interventional patient registry
干预措施: Observational (registry) (Combination Product)
Heart Diseases
Non-interventional patient registry
干预措施: Observational (registry) (Combination Product)
Vascular diseases
Non-interventional patient registry
干预措施: Observational (registry) (Combination Product)
Male
Non-interventional patient registry
干预措施: Observational (registry) (Combination Product)
Female
Non-interventional patient registry
干预措施: Observational (registry) (Combination Product)
Elderly
Non-interventional patient registry
干预措施: Observational (registry) (Combination Product)
Hypertension
Non-interventional patient registry
干预措施: Observational (registry) (Combination Product)
Diabetes
Non-interventional patient registry
干预措施: Observational (registry) (Combination Product)
Dyslipidemias
Non-interventional patient registry
干预措施: Observational (registry) (Combination Product)
结局指标
主要结局
Death all cause
时间窗: 12-month
Occurrence of all cause death
Death all cause
时间窗: 30-day
Occurrence of all cause death
Death all cause
时间窗: 6 month
Occurrence of all cause death
次要结局
- Sepsis(30 day, 6 -12 months)
- Pneumonia(30 day, 6 -12 months)
- Clinically relevant bleeding(30 day, 6 -12 months)
- Thrombosis (arterial, venous)(30 day, 6 -12 months)
- Heart failure(30 day, 6 -12 months)
- Worsening renal function(30 day, 6 -12 months)
- Respiratory Insufficiency(30 day, 6 -12 months)
- Systemic Inflammatory Response Syndrome (SIRS)(30 day, 6 -12 months)
- Activity Daily Living status(30 day, 6 -12 months)
- Depression status(30 day, 6 -12 months)
研究者
Raffaele Bugiardini
Professor
University of Bologna
