Catheter Directed Therapy for Intermediate Risk Pulmonary Embolism Patients Guided by Prediction Model for Impending Shock
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- 1.comparison between conventional medical therapy and catheter-directed therapy in intermediate high risk acute pulmonary embolism patients
研究概览
简要总结
Aim of the work:
- To compare conventional medical therapy versus catheter-directed therapy in intermediate high risk acute pulmonary embolism.
- To define predictors of progression from intermediate to high-risk in medically-treated patients for ideal timing for intervention.
详细描述
Based on history, physical examination, surface 12-lead ECG, bed-side echocardiography, patients with a high probability of acute pulmonary embolism are selected and subjected to CT pulmonary angiography to confirm the diagnosis and calculate the pulmonary artery obstruction score.
Routine labs are withdrawn, including cardiac troponin.Methods:
Detailed TTE will be done with emphasis on the following indicators of RV strain and/or dysfunction:
- Echocardiography findings that are indicative of RV dysfunction
- tricuspid annular plane systolic excursion (TAPSE)
- S' Velocity
- the McConnell's sign
- RV dilation
- interventricular septal flattening.
- elevated right ventricular pressures
- plethoric inferior vena cava
- tricuspid regurgitation
- Direct visualization of thromboembolic in the RT heart and PA
- RV stroke volume measured by RVOT VTI.
- LV stroke volume measured by LVOT VTI Intermediate-high risk patient will be identified (based on the calculated pulmonary embolism severity index, RV dysfunction on TTE and/or CT, cardiac troponin), and then randomized to either receiving conventional medical treatment or catheter-directed interventional therapy if the patient consents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute pulmonary embolism patients (confirmed by CT pulmonary angiography [CTPA])
- •symptoms started within 15 days of enrollment
- •intermediate-high risk pulmonary embolism patients , i.e., who have all of the following risk indicators combined :(2) i.Pulmonary Embolism Severity Index (PESI) class III-V or sPESI ≥1, ii.AND RV dysfunction on TTE or CTPA, iii.AND elevated cardiac troponin levels
- •with none of the following high-risk presentations: cardiac arrest, systolic blood pressure <90 mmHg, or vasopressors required to achieve a BP ≥90 mmHg despite an adequate filling status, or end-organ hypoperfusion.
排除标准
- •high risk patients who are hemodynamically unstable (cardiogenic shock, SBP <90 mmHg, or use of intotropic support).
- •low risk patients with no RV dysfunction.
- •Patients with history of CTEPH (or previous acute PE)
- •Patients known to have other pulmonary hypertension, apart from group IV (CTEPH).
- •Patients with sever kidney injury (eGFR <30 mg/dl/1.7m2).
结局指标
主要结局
1.comparison between conventional medical therapy and catheter-directed therapy in intermediate high risk acute pulmonary embolism patients
时间窗: up to 2 years
comparison in intermediate high risk acute pulmonary embolism patients between conventional medical therapy and catheter-directed therapy as regarding safety and efficacy of the therapy by clinical assessment of occurrence of major adverse cardiac events.
次要结局
- predictors of progression from intermediate to high-risk acute pulmonary embolism patients(up to 2 years)
研究者
Ayman khairy Mohamed
Professor
Assiut University