Thrombolysis via catheter in treatment of Pulmonary Emboli
- Conditions
- Pulmonary emboli.Pulmonary embolism
- Registration Number
- IRCT20181022041406N1
- Lead Sponsor
- Rajaie Cardiovascular Medical and Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 288
Men and women = 18 year-old
Acute pulmonary emboli must be confirmed with pulmonary CT angiography
Symptoms onset = 14 days
Elevated pro b-type natriuretic peptide and cardiac troponin
Right ventricle/left ventricle ratio in pulmonary CT angiography >0.9
simplified pulmonary embolism severity index score >=1
Less than 48 hours of anticoagulation therapy
Pulmonary emboli diagnosed with other modalities than pulmonary CT angiography
High risk (massive) pulmonary Emboli
Segmental pulmonary emboli
Patient with terminal illness
Surgery within 2 weeks
Severe renal dysfunction (creatinine clearance [CrCl] below 30 mL/min)
Platelet count <50.000
Thrombolytic contraindication
Concomitant right heart thrombosis
Pre and post catheter directed thrombolysis echocardiography exam not possible
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Right ventricular diameter/left ventricular diameter ratio. Timepoint: 3-month after intervention. Method of measurement: Echocardiography.
- Secondary Outcome Measures
Name Time Method Mortality. Timepoint: During hospitalization and 3-months after intervention. Method of measurement: Questionnaire.;Minor bleeding. Timepoint: Duration of hospitalization. Method of measurement: Bleeding Academic Research Consortium scale.;Major bleeding. Timepoint: Duration of hospitalization. Method of measurement: Bleeding Academic Research Consortium scale.;Right ventricular diameter/left ventricular diameter ratio. Timepoint: 72 hours after intervention. Method of measurement: Echocardiography.;Right ventricular recovery. Timepoint: 3 months after intervention. Method of measurement: Echocardiography.