NCT04527315招募中不适用
Assessment of ICU and Non-ICU Survivors: A Creation of a COVID Survivorship Database
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Level of Inflammatory Markers
研究概览
简要总结
COVID-19 is associated with acute pulmonary and cardiac injury. To better understand the degree and severity of cardiopulmonary injury as well as short and long-term sequelae of COVID-19 infection, this study will perform longitudinal study in patients who had recent known diagnosis of COVID-19.
详细描述
The objectives for this study include providing structural and function information about lung and heart using chest imaging, MRI, Echo, Spirometry, and blood markers in order to assess severity of cardiopulmonary injury and short- and long-term sequelae of COVID-19 infection as well as assess indicators of mental health and quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •have tested positive for SARS-CoV-2 and discharged from the ICU or,
- •have tested positive for SARS-CoV-2 and have been discharged from hospital or,
- •have tested positive for SARS-CoV-2 but was NOT hospitalized
- •ages 18 and over, and
- •competent and willing to sign informed consent and comply to all aspects of the protocol
- •CONTROL Inclusion Criteria
- •No clinical history of COVID-19,
- •No active clinical symptoms indicative of possible COVID-19,
- •Ages 18 and over,
- •competent and willing to sign informed consent and comply to all aspects of the protocol
排除标准
- •Participants cannot sign consent
- •Any individual who meets any of the following criteria will be excluded from participation to the MRI or x-ray portion of the study:
- •Participants who are pregnant or currently trying to get pregnant
- •Participants unable to comply with any portion of the protocol (i.e. removing metals prior to entering the MRI scan room) or who have contraindications to MRI scanning (i.e., non-MRI-conditional pacemakers/defibrillators, pregnancy, ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)
- •Persistent symptoms related to COVID-19 (in which case the patient may be re-screened later) As is done for all patients undergoing clinical MRI in our department, each patient will be screened for contraindications to MRI with a routine questionnaire prior to scanning.
- •CONTROL Exclusion Criteria
- •Patients with any of the following are excluded from as controls:
- •Pace maker
- •Poorly controlled diabetes
- •Poorly controlled Restrictive lung disease
- •Heart failure
- •Parkinson's Disease
- •Hypertension
- •Any diagnosis or history of autonomic neuropathy
结局指标
主要结局
Level of Inflammatory Markers
时间窗: Up to 12 months
Inflammatory markers include D-dimer, ferritin, and CRP measurements
次要结局
- Score on St. George's Shortness of Breath Questionnaire (SGSQ)(Up to 12 months)
- Score on Short Form Zarit Burden Interview (ZBI-12)(Up to 12 months)
研究者
研究点 (1)
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