Clinical trial NCT05391646: Pulmonary Embolism Registry
Official title: Pulmonary Embolism Registry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pulmonary Embolism
Keywords: Pulmonary Embolism, Venous Thromboembolism, Chronic Thromboembolic Disease
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Unidade Local de Saúde de Matosinhos, EPE
name: Centro Hospitalar Universitário do Porto
name: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
name: Hospital da Luz, Portugal
name: Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro
name: Hospital de Braga
name: Centro Hospitalar de Entre o Douro e Vouga
name: Unidade Local de Saúde do Alto Minho
First posted: 2022-05-26
Enrollment: 500
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: The PERR is a prospective multicentric observational study of consecutive patients with confirmed PE by computed tomographic pulmonary angiography or ventilation-perfusion lung scan.

Brief summary: Acute Pulmonary Embolism (PE) is the most serious clinical presentation of venous thromboembolism (VTE), a leading cause of cardiovascular mortality, exceeded only by stroke and myocardial infarction. Chronic thromboembolic pulmonary hypertension (CTEPH) is the most severe chronic form of CTED and it occurs in 2-4% of patients after acute PE.

In Portugal little is known about PE epidemiology and its outcomes, including complications like CTED. The main goal of this study is, therefore, to understand PE epidemiology and complications in the northern region of Portugal. This information can enable the organization of a structured health care network that can potentially benefit all PE patients.


Eligibility criteria: Inclusion Criteria:

* Acute symptomatic or asymptomatic PE,
* Age \>18 years,
* Availability of a minimum data set for PE and a minimum of 3-months follow-up for the primary objective and 36-months for the secondary one. Except for patients who died prior to the 3 or 36 months follow-up.

Exclusion Criteria:

* Enrolment of the patient in any treatment trial in a blinded fashion,
* Lack or withdrawal of patient´s consent.

Primary outcomes:
measure: Determine Pulmonary Embolism (PE) prevalence in Portugal
timeFrame: From date of inclusion until the end of the study currently planned (3 to 5 years)
measure: Identification of Pulmonary Embolism (PE) risk factors and comorbidities
timeFrame: From date of inclusion until the end of the study currently planned (3 to 5 years)
measure: Determine Pulmonary Embolism (PE) clinical management.
timeFrame: From date of inclusion until the end of the study currently planned (3 to 5 years)
Secondary outcomes:
measure: Access incidence rate of Chronic Thromboembolic Disease (CTED) with or without pulmonary hypertension after acute PE.
timeFrame: From 6 months after date of inclusion until the end of the study currently planned (2 to 5 years)
Other outcomes:
Locations:
Study officials:
affiliation: Universidade do Porto
name: Carolina Guedes, MD, PhDc
role: PRINCIPAL_INVESTIGATOR
References: