MRI Assessment of Pulmonary Edema in Acute Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Magnitude of lung water density measured with MRI at Hospital Admission
研究概览
简要总结
Researchers are testing a more accurate way to measure how much fluid is in the lungs (also called pulmonary edema, or "increased lung water") in people with Heart Failure (HF) using MRI (Magnetic Resonance Imaging). There is little known about the exact level of lung water in patients with AHF or how these levels change from the time of hospital admission to discharge. The purpose of this research study is to measure the lung water in patients hospitalized for HF, to determine the change in lung water over the course of hospitalization and treatment, and to find out if lung water levels can predict if patients are higher or lower risk for returning to the hospital or dying from heart failure.
详细描述
Heart failure is a condition where the heart is unable to pump enough blood to meet the body's needs and Acute Heart Failure is a sudden worsening of this condition. It is associated with many symptoms but most commonly includes shortness of breath due to pulmonary edema (or increased "lung water").
A physical exam and chest x-ray are commonly used to diagnose AHF and estimate the amount of increased lung water in patients with AHF. This study will use images from MRI (Magnetic Resonance Imaging) scans to obtain a more accurate measurement of the increased lung water in AHF patients. Lung water will be measured via MRI at hospital admission and discharge to find out the change in lung water over the course of hospitalization and treatment. The investigators will collect NT-proBNP and perform a chest x-ray upon hospital admission and again upon discharge, if not already done as part of usual care. The investigators will follow medical records for up to 5 years after hospitalization to see if the accurate lung water measurements obtained in hospital can predict long term outcomes. This is a multi-centre project and a total of 300 patients will be recruited to participate.
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
- •18 years of age or older and willing/able to provide informed consent
- •patients being treated for acute heart failure (including those patients with both reduced and preserved ejection fraction)
- •patients receiving medical therapy for pulmonary edema by current standard of care (including oral or IV diuretics)
- •patients identified within 48 hours of initiation of medical therapy for pulmonary edema, defined as the time of first diuretic (IV or PO) or escalation of existing diuretic therapy administered within the ED or hospital
排除标准
- •contraindication to MRI
- •patient too critically ill/unstable as per the clinical care team for transport to MRI scanner within the required scanning window
- •moderate to severe dementia
结局指标
主要结局
Magnitude of lung water density measured with MRI at Hospital Admission
时间窗: Baseline (hospital admission)
Lung water density (0-100%) is the fraction of lung tissue that contains water
Number and timing of clinical events and their statistical association with Outcome 2 (Difference in lung water density measured with MRI at hospital admission and hospital discharge)
时间窗: Up to 5 years
Clinical events include cardiovascular hospitalization, cardiovascular emergency
Number and timing of clinical events and their statistical association with Outcome 1 (Magnitude of lung water density measured with MRI at Hospital Admission)
时间窗: Up to 5 years
Clinical events include cardiovascular hospitalization, cardiovascular emergency department visits or death
Difference in lung water density measured with MRI at hospital admission and hospital discharge
时间窗: 7 days
Absolute change in lung water density from baseline (hospital admission) to hospital discharge. Lung water density will be 0%-100% at each time point.
次要结局
未报告次要终点