Characterizing the Long-Term Cardiopulmonary Effects of COVID-19 With Hyperpolarized Xenon and Cardiac MRI
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Red Blood Cell to Membrane (RBC:M) Ratio
研究概览
简要总结
The next phase of the COVID-19 pandemic is likely to see a surge in an associated chronic cardiopulmonary disease that will challenge health systems. Recovered patients are presenting with persistent dyspnea at the Duke Pulmonary Post-COVID clinic. Evidence is now mounting that recovered patients have significant residual pulmonary disease, while myocardial injury has also been increasingly reported. To optimally care for these patients, Duke Pulmonary study team must comprehensively assess and monitor the changes in cardiopulmonary function and relate the changes to physiologic and quality of life outcomes. The study team will deploy cutting-edge MRI to fully characterize cardiopulmonary function in enrolled 30 subjects (accrual 23 subjects) at time point 60-120 days post recovery and 6-9 months later. Cardiac MRI will assess the myocardial status and right ventricular function, while hyperpolarized 129Xe MRI will provide a 3D assessment of pulmonary ventilation, interstitial barrier integrity, and pulmonary vascular hemodynamics. The overall objective outlined in this study is to demonstrate the feasibility and value of comprehensive longitudinal imaging characterization of cardiopulmonary structure and function in patients recovered from Covid-19.
详细描述
The proposed research builds on the established sensitivity of Hyperpolarized 129Xe MRI to obstructive and pulmonary vascular lung disease, features expected to represented in the Covid-19 cohort. It further incorporates a new understanding of the possible role of myocardial injury in these recovered patients by combining cutting-edge pulmonary and cardiac MRI.
Although the initial presentation of patients with moderate to severe symptoms of COVID19 infections is dominated by respiratory symptoms, 10% go on to develop persistent post-infection symptoms which are thought to have an inflammatory etiology. Evidence suggests that pathologic activation of the inflammasome persists beyond the acute initial presentation that contributes to the persistent disabling symptoms characterized as "long-haul COVID". For this trial, subjects will be eligible for enrollment if subjects are outpatients with a history of a laboratory-confirmed diagnosis of COVID-19 infection, and after 60 days or longer. The study team will accrual 13 subjects who continue to have respiratory symptoms (i.e., cough, shortness of breath, dyspnea on exertion). An additional 10 subjects engaged in competitive sports and diagnosed with COVID-19 will also be enrolled. These subjects can be asymptomatic or mildly to moderately. Although rare, cardiac impairment has been documented in <2% of these individuals. The study team knowledge, XeMRI has not yet been studied in this specific patient subset.
Existing data highlight significant racial and ethnic disparities with historically underserved minority populations (i.e., Black, LatinX) suffering disproportionately higher infection rates and more severe illness compared to Whites. This is reflected by the population enrolled in the study team RedCAP database and biorepository. As such 30% of subjects enrolled will be required to be from underserved communities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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-year-old
- •Tested positive for SARS-CoV2
- •Willing and able to give informed consent and adhere to visit/protocol scheduled (consent must be given before any study procedures are performed)
排除标准
- •Pregnant, planning pregnancy, or lactating
- •Conditions that prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine).
- •Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
研究组 & 干预措施
subjects with diagnosis of COVID-19 (Long-hauler)
23 subjects with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer
干预措施: Hyperpolarized 129Xenon gas (Drug)
结局指标
主要结局
Red Blood Cell to Membrane (RBC:M) Ratio
时间窗: 1 year
To determine cardiopulmonary structure-function abnormalities that characterize early phase COVID-19 recovery.
Ventilation Defect Percent
时间窗: 1 year
To determine cardiopulmonary structure-function abnormalities that characterize early phase COVID-19 recovery.
High Membrane Percent
时间窗: 1 year
To determine cardiopulmonary structure-function abnormalities that characterize early phase COVID-19 recovery.
Red Blood Cell (RBC) Defect Percent
时间窗: 1 year
To determine cardiopulmonary structure-function abnormalities that characterize early phase COVID-19 recovery.
Red Blood Cell to Membrane (RBC:M) Ratio at 9 Months
时间窗: 9 Months
To characterize the evolution of cardiopulmonary abnormalities over 9 months.
Ventilation Defect Percent at 9 Months
时间窗: 9 months
To characterize the evolution of cardiopulmonary abnormalities over 9 months.
High Membrane Percent at 9 Months
时间窗: 9 months
To characterize the evolution of cardiopulmonary abnormalities over 9 months.
Red Blood Cell (RBC) Defect Percent at 9 Months
时间窗: 9 months
To characterize the evolution of cardiopulmonary abnormalities over 9 months.
Identify MRI Features That Predict Physiological Outcomes With DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide)
时间窗: Baseline
DLCO is the extent to which oxygen passes from the air sacs of the lungs into the blood.
次要结局
未报告次要终点
研究者
Bastiaan Driehuys
Associate Professor of Radiology
Duke University
