Pulmonary EmbolismPERNCT05391646
Pulmonary Embolism Registry
An observational study of Pulmonary Embolism, run by Universidade do Porto.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2023to 16 Jun 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Enrolment of the patient in any treatment trial in a blinded fashion,
- Lack or withdrawal of patient´s consent.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary Embolism, Venous Thromboembolism, Chronic Thromboembolic Disease
- Medical subject headings
- Pulmonary Embolism, Venous Thromboembolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Pulmonary Embolism (PE) prevalence in Portugal
Number cases per year
Measured: 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
Measured: 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
Measured: 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.
ratio between the number of patients with CTED with or without pulmonary hypertension and total number of patients with PE
Measured: From 6 months after date of inclusion until the end of the study currently planned (2 to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start31 Oct 2023 (estimated)
- Primary completion16 Dec 2023 (estimated)
- Study completion16 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Unidade Local de Saúde de Matosinhos, EPE, Centro Hospitalar 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, Hospital de Braga, Centro Hospitalar de Entre o Douro e Vouga, Unidade Local de Saúde do Alto Minho
- Responsible party
- Sponsor
- Investigators
- Carolina Guedes, MD, PhDc, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391646
- Sponsor's protocol ID
- PER2022
- Acronym
- PER
- Status last verified
- Oct 2023
- First submitted
- 13 May 2022
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Embolism Registry
- ClinicalTrials.gov ID
- NCT05391646
- Acronym / sponsor ID
- PER / PER2022
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary Embolism, Venous Thromboembolism, Chronic Thromboembolic Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Unidade Local de Saúde de Matosinhos, EPE, Centro Hospitalar 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, Hospital de Braga, Centro Hospitalar de Entre o Douro e Vouga, Unidade Local de Saúde do Alto Minho
- Study start
- 31 Oct 2023 (estimated)
- Primary completion
- 16 Dec 2023 (estimated)
- Study completion
- 16 Jun 2026 (estimated)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Enrolment of the patient in any treatment trial in a blinded fashion,
- Lack or withdrawal of patient´s consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
1 secondary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolina Guedes, MD, PhDc principal investigator
Universidade do Porto
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by Universidade do Porto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carolina Guedes, MD, PhDc ((+351) 93 297 06 93, cncdc@spc.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.