Pulmonary Embolism Registry

Pulmonary Embolism Clinical Trial

— PER  

Official title:

Pulmonary Embolism Registry

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05391646
• Other study ID #: PER2022
• Status: Not yet recruiting
• Start date: October 31, 2023
• Est. completion date: June 16, 2026

Study information

• Verified date: October 2023
• Source: Universidade do Porto
• Contact: Carolina Guedes, MD, PhDc
• Phone: (+351) 93 297 06 93
• Email: cncdc[@]spc.pt
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 16, 2026
• Est. primary completion date: December 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Locations

Country	Name	City	State
n/a

Sponsors (10)

Lead Sponsor	Collaborator
Universidade do Porto	Centro Hospitalar de Entre o Douro e Vouga, Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E., Centro Hospitalar Universitário do Porto, Faculty of Medicine (FMUP), Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro, Hospital da Luz, Portugal, Hospital de Braga, Unidade Local de Saúde de Matosinhos, EPE, Unidade Local de Saúde do Alto Minho

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine Pulmonary Embolism (PE) prevalence in Portugal	Number cases per year	From date of inclusion until the end of the study currently planned (3 to 5 years)
Primary	Identification of Pulmonary Embolism (PE) risk factors and comorbidities	Frequency of risk factors and comorbidities	From date of inclusion until the end of the study currently planned (3 to 5 years)
Primary	Determine Pulmonary Embolism (PE) clinical management.	Identification of diagnostic of diagnostic and treatment profile	From date of inclusion until the end of the study currently planned (3 to 5 years)
Secondary	Access incidence rate of Chronic Thromboembolic Disease (CTED) with or without pulmonary hypertension after acute PE.	ratio between the number of patients with CTED with or without pulmonary hypertension and total number of patients with PE	From 6 months after date of inclusion until the end of the study currently planned (2 to 5 years)