Clinical trial NCT04911192: Catheter-Directed Pulmonary Reperfusion in Treatment of Pulmonary Embolism Patients
Official title: Catheter-Directed Pulmonary Re Perfusion in Treatment of Intermediate and High Risk Pulmonary Embolism Patients and Its Impact on Pulmonary Artery Pressure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Embolism
Keywords: pulmonary embolism
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * Primary objective: to evaluate the success and mortality rates of catheter-directed reperfusion therapy in comparison to traditional use of systemic intravenous fibrinolytic therapy, will focus at safety of such management measured by in-hospital mortality and prevalence of severe adverse events.
* Secondary objective: to assess the feasibility of catheter-directed reperfusion in management of intermediate and high risk pulmonary embolism in Assiut University hospital and its reflection on pulmonary artery pressure

Detailed description: Venous thromboembolic disease represents one of the most important causes of cardiovascular death in the world. Symptomatic pulmonary embolism (PE) occurs in about 500,000 patients annually, with an estimated mortality as high as 30% in high-risk patients .

High-risk pulmonary embolism clinically manifests with hemodynamic instability and systemic hypotension (systolic blood pressure \< 90 mm Hg, pressure drop of more than 40 mm Hg or requiring administration of inotropic agents. In this form of PE (pulmonary embolism) imaging studies usually reveal a "saddle embolus" at the bifurcation of the pulmonary trunk, embolism of the main pulmonary artery, or embolic occlusion of at least two lobar arteries.

Mortality in high-risk pulmonary embolism is at the level of 60%, and in 66% of these patients fatal outcomes take place during the first hours from the onset of clinical symptoms. The remaining patients with severe pulmonary embolism , those with intermediate risk of mortality, do not reveal hypotension, but present with clinical symptoms comprising dyspnea and/or tachycardia. Estimated 30-day mortality in patients with intermediate risk PE (pulmonary embolism) is at the level of 15-20%, and these patients are at a risk of developing pulmonary hypertension and right ventricle heart failure. Given the fact that 40% of patients with class 4 or 5 of the Pulmonary Embolism Severity Index present with contraindications for systemic fibrinolytic therapy, Catheter-directed reperfusion therapy seems to be a promising alternative treatment modality.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years old.
* Both gender males and females.
* Patients with angiographically confirmed acute high risk pulmonary embolism with shock index \>1.
* pulmonary arterial occlusion with \>50% involvement of the central (main and/or lobar) pulmonary, and dysfunction of the right ventricle and elevated troponin.
* patients with high risk pulmonary embolism who remain unstable after receiving fibrinolysis
* patients with high risk PE pulmonary embolism who cannot receive fibrinolysis
* patients with intermediate high risk PE pulmonary embolism with adverse prognosis (new hemodynamic instability, worsening respiratory failure, severe RV (right ventricle) dysfunction, or major myocardial necrosis)

Exclusion Criteria:

* patients with echocardiographically confirmed right sided thrombi.
* patients with low-risk PE pulmonary embolism or submassive acute PE pulmonary embolism with minor RV (right ventricle) dysfunction, minor myocardial necrosis, and no clinical worsening
* Anaphylactic reaction to contrast media.
* Acute renal failure or severe chronic non-dialysis dependent kidney disease.
* Uncooperative patient

Primary outcomes:
measure: Rate of mortality (mortality rate)
timeFrame: 30-day
measure: Rate of complications
timeFrame: 7 days
measure: Rate of Success
timeFrame: 2 weeks
Secondary outcomes:
measure: Percent of Changes in mean blood pressure
timeFrame: Baseline (measured at first admission) and compared with measurements the following second, eighth, and 24th hours of the intervention.
measure: Mean pulmonary artery pressure
timeFrame: Baseline (at addmission) and 24 hours after catheter-directed intervention
measure: Duration of ICU(intensive care unit) stay
timeFrame: "through study completion, an average of 1 year".
measure: Duration of hospital stay
timeFrame: "through study completion, an average of 1 year".
Other outcomes:
Locations:
Study officials:
affiliation: professor of chest diseases and tuberculosis
name: mohamed M abd el hadi, prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Ayman k hassan, lecturer
role: STUDY_DIRECTOR
affiliation: Assiut University
name: olfat M El shinnawy, prof
role: STUDY_CHAIR
affiliation: Assiut University
name: Aliaa S Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Nassiri N, Jain A, McPhee D, Mina B, Rosen RJ, Giangola G, Carroccio A, Green RM. Massive and submassive pulmonary embolism: experience with an algorithm for catheter-directed mechanical thrombectomy. Ann Vasc Surg. 2012 Jan;26(1):18-24. doi: 10.1016/j.avsg.2011.05.026. Epub 2011 Aug 31.
citation: Anderson FA Jr, Zayaruzny M, Heit JA, Fidan D, Cohen AT. Estimated annual numbers of US acute-care hospital patients at risk for venous thromboembolism. Am J Hematol. 2007 Sep;82(9):777-82. doi: 10.1002/ajh.20983.
citation: Konstantinides SV, Torbicki A, Agnelli G, Danchin N, Fitzmaurice D, Galie N, Gibbs JS, Huisman MV, Humbert M, Kucher N, Lang I, Lankeit M, Lekakis J, Maack C, Mayer E, Meneveau N, Perrier A, Pruszczyk P, Rasmussen LH, Schindler TH, Svitil P, Vonk Noordegraaf A, Zamorano JL, Zompatori M; Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014 Nov 14;35(43):3033-69, 3069a-3069k. doi: 10.1093/eurheartj/ehu283. Epub 2014 Aug 29. No abstract available.