Pulmonary Embolism Registry (PER)

October 18, 2023 updated by: Universidade do Porto

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Carolina Guedes, MD, PhDc
  • Phone Number: (+351) 93 297 06 93
  • Email: cncdc@spc.pt

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine Pulmonary Embolism (PE) prevalence in Portugal
Time Frame: From date of inclusion until the end of the study currently planned (3 to 5 years)
Number cases per year
From date of inclusion until the end of the study currently planned (3 to 5 years)
Identification of Pulmonary Embolism (PE) risk factors and comorbidities
Time Frame: From date of inclusion until the end of the study currently planned (3 to 5 years)
Frequency of risk factors and comorbidities
From date of inclusion until the end of the study currently planned (3 to 5 years)
Determine Pulmonary Embolism (PE) clinical management.
Time Frame: From date of inclusion until the end of the study currently planned (3 to 5 years)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Access incidence rate of Chronic Thromboembolic Disease (CTED) with or without pulmonary hypertension after acute PE.
Time Frame: 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
From 6 months after date of inclusion until the end of the study currently planned (2 to 5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Porto

Collaborators

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

Investigators

  • Principal Investigator: Carolina Guedes, MD, PhDc, Faculty of Medicine (FMUP)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 31, 2023

Primary Completion (Estimated)

December 16, 2023

Study Completion (Estimated)

June 16, 2026

Study Registration Dates

First Submitted

May 13, 2022

First Submitted That Met QC Criteria

May 20, 2022

First Posted (Actual)

May 26, 2022

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PER2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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