NCT05391646

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Oct 2023

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress96%
Oct 2023Jun 2026

First Submitted

Initial submission to the registry

May 13, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 31, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2023

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2026

Expected
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

May 13, 2022

Last Update Submit

October 18, 2023

Conditions

Pulmonary Embolism

Keywords

Pulmonary Embolism, Venous Thromboembolism, Chronic Thromboembolic Disease

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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 Outcomes (1)

  • 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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary EmbolismVenous Thromboembolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesThromboembolism

Study Officials

  • Carolina Guedes, MD, PhDc

    Universidade do Porto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolina Guedes, MD, PhDc

CONTACT

(+351) 93 297 06 93cncdc@spc.pt

Janete Santos, PhD

CONTACT

(+351) 225 513 600investigaclinica@med.up.pt

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2022

First Posted

May 26, 2022

Study Start

October 31, 2023

Primary Completion

December 16, 2023

Study Completion (Estimated)

June 16, 2026

Last Updated

October 19, 2023

Record last verified: 2023-10