Pulmonary Embolism Registry

Not yet recruiting

• Conditions: Pulmonary Embolism

• Registration Number: NCT05391646
• Lead Sponsor: Universidade do Porto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-13
• Study First Submitted QC: 2022-05-20
• Study First Posted: 2022-05-26
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19
• Study Start: 2023-10-31
• Primary Completion: 2023-12-16
• Study Completion: 2026-06-16

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of Pulmonary Embolism (PE) risk factors and comorbidities	From date of inclusion until the end of the study currently planned (3 to 5 years)	Frequency of risk factors and comorbidities
Determine Pulmonary Embolism (PE) prevalence in Portugal	From date of inclusion until the end of the study currently planned (3 to 5 years)	Number cases per year
Determine Pulmonary Embolism (PE) clinical management.	From date of inclusion until the end of the study currently planned (3 to 5 years)	Identification of diagnostic of diagnostic and treatment profile

Secondary Outcome Measures

Name	Time	Method
Access incidence rate of Chronic Thromboembolic Disease (CTED) with or without pulmonary hypertension after acute PE.	From 6 months after date of inclusion until the end of the study currently planned (2 to 5 years)	ratio between the number of patients with CTED with or without pulmonary hypertension and total number of patients with PE