WHF COVID-19 and Cardiovascular Disease Survey
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,200
- 试验地点
- 32
- 主要终点
- Assessment of the patients for major adverse cardiovascular events (MACE)
研究概览
简要总结
A global study for a better understanding of the cardiovascular conditions that increase the risk of developing severe COVID-19, and a better characterization of cardiovascular complications in hospitalized patients with COVID-19.
详细描述
COVID-19 may be cardiotropic in a subset of patients. Both acute and pre-existing CVD impact outcomes unfavorably. It is possible that one common CVD treatment, medications that impact ACE-2 function, may impact outcomes either favorably or unfavorably.
However, studies so far have, perforce, been conducted with important limitations (e.g. small numbers, limited geographical representation, lack of data standardization for risk factors and outcomes, limited measurement, lack of appropriate adjustment for important confounders, and missing data). Considering the high global prevalence of CVD and its risk factors (e.g. hypertension and diabetes) and the suggested link with COVID19 it is urgent to initiate more robust studies to clarify the many issues early reports have engendered. So that investigators will conduct a global study for a better understanding of the cardiovascular conditions that increase the risk of developing severe COVID-19, and a better characterization of cardiovascular complications in hospitalized patients with COVID-19.
Given the continued increase in the COVID-19 cases worldwide, the study team launched WHF COVID-19 and CVD Extension Study to continue recruitment of the COVID-19 patients hospitalized in the selected high-income, middle-income, and low-income countries (sample size = 3300 patients). This extension study will provide valuable insights on the temporal trends in clinical characteristics of COVID-19, the specific cause of deaths such as sudden cardiac death and its relationship with COVID-19 infection, the impact of COVID-19 vaccination on the clinical outcomes at discharge and overall mortality, and anti-microbial resistance and its association with outcomes in COVID-19 patients.
Further, the study team is also conducting a WHF COVID-19 Long-term follow-up Study in a sample of 2000 patients from the WHF COVID-19 extension study that aims to determine the short- (3 month), medium- (6 month) and long-term (9-12 month) sequelae to COVID-19 including ongoing symptomatology, re-hospitalizations, mortality, impact on physical function and psycho-social consequences. The long-term sequelae of COVID-19 post hospital discharge are unknown, and the trajectories are likely to be heterogeneous across countries. This study will provide invaluable information about the intermediate to long-term effects of COVID-19 and the disease burden and economic impact of COVID-19 on patients with long term sequelae.
Sample Size:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •All adults (as locally defined) with confirmed COVID-19 infection who are hospitalized are eligible.
排除标准
- •Patients for whom investigators are unable to obtain informed consent will be excluded.
- •Patients who are unlikely to stay in the recruiting centre for 30 days (i.e. likely to be transferred)
结局指标
主要结局
Assessment of the patients for major adverse cardiovascular events (MACE)
时间窗: Outcome will be assessed at discharge and 30-day follow-up visit from the hospital admission date.
MACE is defined as the presence of any of the following CVD conditions: myocarditis, arrhythmia, heart failure \[including Left ventricular ejection fraction\], acute coronary event, as per the hospital admission and discharge records. Data will be collected at each site by local investigators and sent to the coordinating center. Only data outlined on the entry and outcome forms will be collected.
Assessment of the patients for Pulmonary outcomes including Pulmonary embolism, pneumonia, acute respiratory distress syndrome, need of intensive care - number of days in ICU or ICCU, need of ventilator]
时间窗: at discharge and 30-day follow-up visits from the hospital admission date.
Data will be collected at each site by local investigators and sent to the coordinating center. Only data outlined on the entry and outcome forms will be collected.
All cause deaths
时间窗: any time during the hospital admission and at 30-day follow-up.
Specific causes of death to be evaluated using CRF including sudden cardiac death, death due to Myocardial infarction, Death due to heart failure, death due to stroke
Persistence of long-COVID Symptoms at 6-month after discharge among survivors of COVID-19 hospitalizations.
时间窗: 6-month after hospital discharge
Questionnaires will be administered telephonically at 6-month after hospital discharge. Data will be collected at each site by local investigators and sent to the coordinating center.
Impact of COVID-19 vaccination on clinical outcomes - MACE (major adverse cardiovascular events) in COVID-19 hospitalized patients.
时间窗: upto 30 days
MACE is defined as the presence of any of the following CVD conditions: myocarditis, arrhythmia, heart failure \[including Left ventricular ejection fraction\], acute coronary event, as per the hospital admission and discharge records. Data will be collected at each site by local investigators and sent to the coordinating center. Only data outlined on the entry and outcome forms will be collected.
Persistence of long-COVID Symptoms at 3-month after discharge among survivors of COVID-19 hospitalizations.
时间窗: 3-month after hospital discharge
Questionnaires will be administered telephonically at 3-month after hospital discharge. Data will be collected at each site by local investigators and sent to the coordinating center.
Persistence of long-COVID Symptoms at 9-12-month after discharge among survivors of COVID-19 hospitalizations.
时间窗: 9-12-month after hospital discharge
Questionnaires will be administered telephonically at 9-12-month after hospital discharge. Data will be collected at each site by local investigators and sent to the coordinating center.
Assessment of the patients for Neurological Outcomes including stroke and Transient Ischemic Attack (TIA)
时间窗: at discharge and 30-day follow-up visits from the hospital admission date.
Data will be collected at each site by local investigators and sent to the coordinating center. Only data outlined on the entry and outcome forms will be collected.
Persistence of long-COVID Symptoms at 1-month after discharge among survivors of COVID-19 hospitalizations.
时间窗: 1-month after hospital discharge
Questionnaires will be administered telephonically at 1-month after hospital discharge. Data will be collected at each site by local investigators and sent to the coordinating center.
次要结局
未报告次要终点
研究者
Dorairaj Prabhakaran
Prof
Public Health Foundation of India