Continuous Aspiration Thrombectomy in High and Intermediate-high Risk Pulmonary Embolism Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Reduction of pulmonary arterial pressures
研究概览
简要总结
Pulmonary embolism is one of the leading causes of cardiovascular death. Pulmonary embolism may be life-threatening condition with an estimated 30-day mortality rate about 10-30%. In high-risk pulmonary embolism, systemic thrombolysis is indicated, whereas recent development of interventional cardiology has made catheter-directed techniques an important alternative to thrombolytic therapy. The controversy concerns also risk stratification and treatment in intermediate-high risk pulmonary embolism patients. A significant percentage of intermediate-high risk patients with pulmonary embolism may experience rapid hemodynamic deterioration and then the prognosis in this group is significantly worse. Catheter-directed techniques are aimed to quickly relive obstruction and restore pulmonary blood flow, thus increasing cardiac output and immediately restoring hemodynamic stability.
The scope of this study is to evaluate the safety and feasibility of catheter-directed approaches in high-risk and intermediate-high risk pulmonary embolism patients.
详细描述
Pulmonary embolism is one of the leading causes of cardiovascular death. Pulmonary embolism may be life-threatening condition with an estimated 30-day mortality rate about 10-30%. In high-risk pulmonary embolism, systemic thrombolysis is indicated, whereas recent development of interventional cardiology has made catheter-directed techniques an important alternative to thrombolytic therapy. The controversy concerns also risk stratification and treatment in intermediate-high risk pulmonary embolism patients. A significant percentage of intermediate-high risk patients with pulmonary embolism may experience rapid hemodynamic deterioration and then the prognosis in this group is significantly worse. Catheter-directed techniques are aimed to quickly relive obstruction and restore pulmonary blood flow, thus increasing cardiac output and immediately restoring hemodynamic stability.
The scope of this study is to evaluate the safety and feasibility of catheter-directed approaches in high-risk and intermediate-high risk pulmonary embolism patients.
The primary data recorded include details of each patient's clinical status, co-morbidities with the Charlson Comorbidity Index, the implemented catheter-directed therapy, the results of additional studies (lab tests results, electrocardiogram, imaging studies), and the outcome. The study endpoints comprise technical success, clinically relevant procedure-related complications or bleeding events, classified according to the Valve Academic Research Consortium-2 guidelines criteria.
Collecting the fore mentioned data allows for clinicians to better manage the pulmonary embolism patients with increased mortality risk.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Clinical symptoms and presentation consistent with pulmonary embolism (PE).
- •PE symptoms duration ≤ 14 days.
- •High risk PE patients with absolute contraindications to systemic thrombolysis or its failure (refractory circulatory collapse) not eligible for surgical embolectomy.
- •Intermediate-high risk PE patients with right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level with concomitant at least one of below criterium for minimum 24 hours:
- •Systolic blood pressure > 90 mmHg and ≤ 100 mmHg
- •Heart rate ≥ 110/min,
- •Arterial blood saturation <90% during spontaneous breathing (atm)
- •Intermediate-high risk PE patients with right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level with sudden occurrence of one or more of the below listed factors:
- •Systolic blood pressure > 90 mmHg and ≤ 100 mmHg
- •Heart rate≥ 110/min,
- •Arterial blood saturation <90% during spontaneous breathing (atm)
排除标准
- •Refusal to sign the informed consent form.
- •Presence of intracardiac thrombus.
- •Diagnosed thrombophilia.
- •Severe thrombocytopenia (platelets count below 20 000 µL).
- •History of severe or chronic pulmonary hypertension.
- •Serum creatinine level higher than 1.8 mg/dl.
- •Known serious and uncontrolled sensitivity to radiographic agents.
结局指标
主要结局
Reduction of pulmonary arterial pressures
时间窗: Immediately after catheter-directed thrombectomy procedure
Incidence of the reduction of systolic and mean pulmonary arterial pressures (mmHg) more than 10% immediately after CDT procedure.
Reduction of vascular obstruction
时间窗: Immediately after catheter-directed thrombectomy procedure
Incidence of the at least 50% reduction of vascular obstruction in the angiography assessed with Miller Index score
Ventricular strain reduction
时间窗: 24 hours after catheter-directed thrombectomy
Rate of right ventricular strain reduction (right ventricle/left ventricle ratio assessment) in echocardiography 24 hours after the CDT.
Clinical improvement during catheter-directed thrombectomy (CDT) procedure
时间窗: Immediately after catheter-directed thrombectomy procedure
Incidence of arterial blood saturation increase \>92%
Early mortality rate from pulmonary embolism
时间窗: 24 hours after catheter-directed thrombectomy
Number of patients who died from pulmonary embolism (right heart failure) during the first 24 hours after CDT.
次要结局
- Total mortality rate from pulmonary embolism(3 months after catheter-directed thrombectomy)
- Bleeding events incidence(3 months after catheter-directed thrombectomy)
- Adverse events incidence(3 months after catheter-directed thrombectomy)
研究者
Aleksander Araszkiewicz
Associate Professor of Medicine
Poznan University of Medical Sciences