Registry of Catheter Intervention in Pulmonary Embolism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pulmonary Embolism, Pulmonary Embolism Acute Massive, Pulmonary Embolism Acute, Pulmonary Embolism and Thrombosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- All cause-death [Time frame: during hospital admission (up to day 10)]
Secondary outcome measures (5)
- all cause-death [Time frame: 48 hours]
- all cause-death [Time frame: 30 days]
- all cause-death [Time frame: 2 year]
- procedural success [Time frame: 48 hours]
- in-hospital complications [Time frame: during hospital admission (up to day 10)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Hospital Clinico San Carlos — Madrid
Publications
- 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. PMID 36801109
- 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-direct PMID 37354942
Identifiers
NCT: NCT06348459 · 18/010-E