Uncovering the Cardiac Phenotype of Individuals With SARS-COV-2 and Cardiac Injury
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Prevalence of Myocarditis
研究概览
简要总结
At the end of December of 2019, a series of patients in Wuhan, China were struck with a mysterious respiratory infection. These isolated events have rapidly grown into a deadly, global pandemic. This pandemic is caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), which results in the Coronavirus Disease 2019 (COVID-19). For individuals infected with COVID-19, approximately 30% of the hospitalized cases are associated with cardiovascular complications. Data are emerging that individuals with pre-exiting conditions (like hypertension, diabetes, cancer, or medical issues related to the immune system) are most susceptible to complications related to COVID-19. Furthermore, individuals of certain racial and ethnic backgrounds (e.g. African American and Hispanic) are at a higher risk of death from COVID-19. Despite these emerging observations, it remains unclear who will develop the cardiovascular complications (acute myocardial injury with evidence of a myocarditis-like picture and cardiogenic shock) and what the long term sequelae of this disease will be for survivors of this infection after hospitalization. Thus, the goals of this project are to better understand the epidemiology of cardiac injury in acutely ill COVID-19 patients through deep cardiac phenotyping and identify the molecular profile of individuals most susceptible to cardiac injury from COVID-19.
详细描述
This will be a cross-sectional cohort study of participants who will undergo a detailed cardiovascular imaging evaluation and blood draw once they have recuperated from a prior index-hospitalization at Clements University Hospital or Parkland Memorial Hospital in Dallas, Texas, USA for COVID-19 and are no longer contagious (~4-6 weeks post hospitalization). Due to the uncertainty with which the extent of cardiac injury represents phenotypic cardiac manifestations in COVID-19, the investigators plan to enroll individuals according to their highest, in-hospital, (high sensitivity - cardiac troponin T) hs-cTnT. The following proposed stratification scheme will afford testing a spectrum hs-cTnT levels.
Table: Enrollment strata by hs-cTnT (N=70)
hs-cTnT [ng/L] < 50 50-100 101-500 > 500
Enrollment N=20 N=20 N=20 N=10
The investigators propose the following exploratory protocol for deep phenotyping to characterize surviving patients with COVID-19 and elevated hs-cTnT during hospitalization.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and non-pregnant women 18-80 years old who were previously hospitalized with confirmed COVID-19
- •Were alive at the time of discharge from COVID-19 hospitalization
- •Had measured hs-cTnT levels during hospitalization
排除标准
- •Prior cardiovascular disease (before COVID-19 infection), defined as self-reported history or electronic medical record diagnosis of cardiac arrest, myocardial infarction, coronary revascularization, heart failure, or stroke prior to COVID-19 hospitalization
- •Urgent-coronary revascularization or type I myocardial infarction within the preceding 30 days
- •Cardiac transplantation
- •Body weight >250 lbs
- •Moderate to severe chronic renal dysfunction defined by an eGFR ≤30 mL/min/1.73 m2
- •Inability to safely undergo a CMR
- •Unwilling or unable to provide informed consent
结局指标
主要结局
Prevalence of Myocarditis
时间窗: Up to 4 weeks
Patterns of late gadolinium enhancement and T1 and T2 mapping consistent with myocarditis on a post-hospitalization cardiac magnetic resonance imaging examination
次要结局
- Prevalence of cardiac abnormalities by cardiac magnetic resonance imaging(Up to 4 weeks)
- Prevalence of molecular and genetic immune system abnormalities(Up to 4 weeks)
研究者
Justin Grodin
Assistant Professor
University of Texas Southwestern Medical Center