跳至主要内容
临床试验/NCT05188612
NCT05188612招募中不适用

International Survey of Acute Coronavirus Syndromes (ISACS)-COVID-19

University of Bologna3 个研究点 分布在 2 个国家目标入组 10,000 人开始时间: 2021年12月1日最近更新:
适应症
干预措施

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:

  1. 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.
  2. 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

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

发起方
University of Bologna
申办方类型
Other
责任方
Principal Investigator
主要研究者

Raffaele Bugiardini

Professor

University of Bologna

研究点 (3)

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