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NCT05612854
Catheter Directed Therapy in Intermediate Risk Pulmonary Embolism Patients
Conditions: Pulmonary Embolism Subacute Massive
Sex: All
Ages: 20 Years – 80 Years
Phase: EARLY_PHASE1
Enrollment: 200
Sponsor: Assiut University
Summary
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.
Eligibility Criteria
Inclusion Criteria:Acute pulmonary embolism patients (confirmed by CT pulmonary angiography [CTPA])symptoms started within 15 days of enrollmentintermediate-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 levelswith 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.Exclusion Criteria: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).
Source: ClinicalTrials.gov (NCT05612854). StuddyBuddy aggregates publicly available trial information.