Clinical trial NCT06348459: Registry of Catheter Intervention in Pulmonary Embolism
Official title: Registry of Catheter Intervention in Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Embolism
Pulmonary Embolism Acute Massive
Pulmonary Embolism Acute
Pulmonary Embolism and Thrombosis
Pulmonary Thromboembolisms
Keywords: Aspiration Thrombectomy
Percutaneous Aspiration Thrombectomy
Local Thrombolysis
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
Collaborators: name: Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología
First posted: 2024-04-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients admitted for moderate-high risk or high-risk PE and treated invasively with any kind of catheter-directed intervention.

Brief summary: Multicenter longitudinal observational ambispective (retrospective cases from 2014 and prospective from 2018 onwards) cohort study. The registry recruits a series of consecutive patients admitted for moderate-high risk or high-risk pulmonary embolism (according to 2019 European Society of Cardiology guidelines) treated invasively. This study aims to describe the acute management of the safety and effectiveness of different percutaneous interventions for acute pulmonary embolism.


Eligibility criteria: Inclusion Criteria:

* adult patients (aged 18 years old or older)
* confirmed diagnosis of acute PE (on computed tomography or echocardiogram plus pulmonary angiography)
* high-risk PE or intermediate-high risk according to ESC risk stratification in the 2019 guidelines (briefly, elevated cardiac biomarkers \[troponin or N-terminal pro-B-type natriuretic peptide\], and right ventricle to left ventricle ratio \> 0.9 \[on computed tomography or echocardiogram\], and PE severity index III to IV or simplified PE severity index=1
* eligibility for catheter-directed intervention

Exclusion Criteria:

* unconfirmed diagnosis of PE
* undefined risk stratification, and
* PE with uncertain chronology or beyond seven days of symptom initiation.

Primary outcomes:
measure: All cause-death
timeFrame: during hospital admission (up to day 10)
Secondary outcomes:
measure: all cause-death
timeFrame: 48 hours
measure: all cause-death
timeFrame: 30 days
measure: all cause-death
timeFrame: 2 year
measure: procedural success
timeFrame: 48 hours
measure: in-hospital complications
timeFrame: during hospital admission (up to day 10)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
References:
citation: Ramos-Lopez N, Ferrera C, Luque T, Enriquez-Vazquez D, Mahia-Casado P, Galvan-Herraez L, Pedrajas JM, Salinas P; working group. Impact of a pulmonary embolism response team initiative on hospital mortality of patients with bilateral pulmonary embolism. Med Clin (Barc). 2023 Jun 9;160(11):469-475. doi: 10.1016/j.medcli.2022.12.017. Epub 2023 Feb 16. English, Spanish.
citation: Salinas P, Vazquez-Alvarez ME, Salvatella N, Ruiz Quevedo V, Velazquez Martin M, Valero E, Rumiz E, Jurado-Roman A, Lozano I, Gallardo F, Amat-Santos IJ, Lorenzo O, Portero Portaz JJ, Huanca M, Nombela-Franco L, Vaquerizo B, Ramallal Martinez R, Maneiro Melon NM, Sanchis J, Berenguer A, Gallardo-Lopez A, Gutierrez-Ibanes E, Mejia-Renteria H, Cordoba-Soriano JG, Jimenez-Mazuecos JM. Catheter-directed therapy for acute pulmonary embolism: results of a multicenter national registry. Rev Esp Cardiol (Engl Ed). 2024 Feb;77(2):138-147. doi: 10.1016/j.rec.2023.06.005. Epub 2023 Jun 22. English, Spanish.