Quantitative 3-Dimensional Chest CT Vascular Reconstruction Before and After Anticoagulation for Pulmonary Embolism (OPTALYSE-3DAC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Perfusion of the pulmonary arteries
研究概览
简要总结
Design: U.S.-based, single-center, proof-of-concept study
Brief Description: A standard clinical contrast-enhanced chest CT scan performed 48 hours after clinically-indicated standard anticoagulation will be compared with a standard clinically-indicated baseline contrast-enhanced chest CT scan using a previously-studied and previously-validated 3-dimensional reconstruction technique to assess changes in the pulmonary vasculature in patients with acute pulmonary embolism (PE). This previously-studied and previously-validated 3-dimensional reconstruction technique has been used to assess the response of the pulmonary vasculature to catheter-based fibrinolysis in acute PE as well as to assess the pulmonary vasculature in a number of chronic lung diseases. However, the pulmonary vascular response to standard anticoagulation for acute PE has not been assessed previously.
Purpose: To compare the pulmonary vasculature before and after standard clinically-indicated anticoagulation for acute PE using a previously-studied and previously-validated 3-dimensional reconstruction technique applied with a standard clinically-indicated baseline contrast-enhanced chest CT scan (used to diagnose the acute PE) and a standard clinical contrast-enhanced chest CT scan performed 48 hours later as indicated by the study protocol.
Population: Inpatients diagnosed with acute PE, in whom clinical providers have prescribed standard anticoagulation alone for treatment based on clinical grounds at Brigham and Women's Hospital.
Enrollment: 10 subjects with acute PE
Clinical Site Location: Single-center, Brigham and Women's Hospital
Study Duration: 12 months
Primary Imaging Outcome: CT-determined percent change in perfusion of the pulmonary vasculature from baseline to 48 hours in inpatients diagnosed with acute PE, in whom clinical providers have prescribed standard anticoagulation alone for treatment based on clinical grounds at Brigham and Women's Hospital.
Secondary Imaging Outcome: CT-determined percent change in right ventricular (RV) volume from baseline to 48 hours in inpatients diagnosed with acute PE, in whom clinical providers have prescribed standard anticoagulation alone for treatment based on clinical grounds at Brigham and Women's Hospital.
详细描述
The pulmonary vascular response to ultrasound-facilitated, catheter-directed fibrinolysis for treatment of pulmonary embolism (PE) results in rapid improvement in patient symptoms and right ventricular (RV) recovery, while minimizing the risk of intracranial hemorrhage. The investigators recently completed an analysis of the chest computed tomographic (CT) data from the SEATTLE II Trial of ultrasound-facilitated, catheter-directed fibrinolysis for treatment of PE using a previously-validated 3-dimensional (3D) reconstruction technique pioneered at Brigham and Women's Hospital (BWH). This software-based 3D technique enables anatomic and structural resolution of the distal pulmonary arteries (microvasculature) far beyond the imaging capabilities of clinically utilized methods. This technique also provides a precise quantitation of RV volume and quantification of the perfusion of the proximal and distal pulmonary arteries. In our 3D reconstruction analysis of the multicenter, U.S.-based SEATTLE II Trial chest CT data, the investigators found that loss of intraparenchymal blood vessel volume was associated with RV enlargement and change in distal small vessel pulmonary artery perfusion predicted RV recovery with ultrasound-facilitated, catheter-directed fibrinolysis in subjects with acute PE. These data were presented at the American Heart Association (AHA) Annual Scientific Sessions in 2017 and have been submitted for publication.
While ultrasound-facilitated, catheter-directed fibrinolysis has been studied using this 3D reconstruction technique, the pulmonary vascular response in PE patients treated clinically with anticoagulation alone has not been. The investigators propose a study to evaluate inpatients diagnosed with acute PE, in whom clinical providers have already prescribed standard anticoagulation alone for treatment based on clinical grounds at Brigham and Women's Hospital, applying this 3-dimensional reconstruction technique to compare data from a standard clinical contrast-enhanced chest CT scan performed 48 hours after initiation of therapy and those data from the standard clinically-indicated baseline contrast-enhanced chest CT scan.
The specific aims for this proposed study are as follows:
Aim #1: To quantify the CT-determined percent change in perfusion of the pulmonary vasculature from baseline to 48 hours in inpatients diagnosed with acute PE, in whom clinical providers have prescribed standard anticoagulation alone for treatment based on clinical grounds at Brigham and Women's Hospital.
Hypothesis #1: The greatest change in pulmonary vascular perfusion following anticoagulation alone for acute PE will take place in the distal small (<5 mm2 cross-sectional area) pulmonary arteries compared with larger (>5 mm2 cross-sectional area) vessels. However, the magnitude of change will be less than that observed in our previously reported analysis focused on patients with acute PE undergoing ultrasound-facilitated, catheter-based fibrinolysis.
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
- •Inpatients diagnosed with acute PE, in whom clinical providers have elected to prescribe anticoagulation alone for treatment based on clinical grounds at BWH.
- •Eligibility for the study will include patients over the age of 18 with bilateral proximal PE on CT (filling defect in ≥ 1 main, lobar, or segmental pulmonary artery), PE symptom duration ≤ 14 days, RV-to-LV diameter ratio ≥ 0.9 on contrast-enhanced chest CT, and a clinically-determined decision to pursue treatment with anticoagulation alone.
排除标准
- •Serum creatinine greater than 2 mg/dL
- •GFR < 60 mL/min
- •Pregnancy (pregnancy test will have been done as standardly required by Radiology before the initial clinically-indicated, clinically-protocolled chest CT)
- •Contrast allergy
- •Treatment with any fibrinolytics-based technique, or surgical/ catheter embolectomy
- •Expected hospital stay < 48 hours. The length of stay will be determined by the treating provider prior to enrollment. Subjects will not extend their stay to 48 hours if they are deemed ready for discharge prior to the time.
结局指标
主要结局
Perfusion of the pulmonary arteries
时间窗: 48 ± 6 hours
Percent change in perfusion of the pulmonary arteries using quantitative 3-D vascular reconstruction of baseline and follow-up (at 48 ± 6 hours) standard contrast-enhanced chest CTs.
次要结局
- Change in RV volume(48 ± 6 hours)
研究者
Gregory Piazza, MD, MS
Associate Director, Thrombosis Research Group
Brigham and Women's Hospital