Pulmonary Embolism (Diagnosis)NCT06756373
Mangement of Pulmonary Emboli
An observational study of Pulmonary Embolism (Diagnosis), run by Assiut University.
Trial summary
To assess to which extent we are adherent to ESC guidelines 2019 in management of patients presented with acute pulmonary embolism Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Embolism (Diagnosis)
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2025to 17 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: treatment of patient with pulmonary embolism according to ECS Guidlines
Who may be able to join
- No includion criteria
Who cannot join
- No exclusion criteria
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Adherence to International Guidelines Directed Risk Stratification and Management of Acute Pulmonary Embolism, an Egyptian Experience
To assess to which extent we are adherent to ESC guidelines 2019 in management of patients presented with acute pulmonary embolism
Read the detailed description
Pulmonary embolism (PE) is the third most frequent cardiovascular disease and is associated with a high mortality burden PE is defined as the obstruction of a pulmonary artery, mostly resulting from the dislodgement of thrombotic material from the lower limbs. It has a wide variety of presentations, ranging from an asymptomatic incidental finding to circulatory collapse and sudden death Pulmonary embolism response teams (PERTs) have emerged as a multidisciplinary team for managing acute pulmonary embolism, with a rapid activation process for multimodality assessment, risk stratification and best management especially for complex challenge cases. PERTs help in improving time to PE diagnosis; shorter time to initiation of anticoagulation reducing hospital length of stay, increasing use of advanced therapies as catheter directed therapies without an increase in bleeding complications with decreasing mortality
- Conditions
- Pulmonary Embolism (Diagnosis)
- Keywords
- simplified pulmonary embolism l index, POPE
- Medical subject headings
- Pulmonary Embolism, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| To assess to which extent we are adherent to ESC guidelines 2019 in management of patients presented | Comparing ESC 2019 criteria for risk stratification and mortality with new scores [BOVA , modified FAST, PEITHO-3 models \& POPE]. -Comparing management and outcomes of in hospital and 30 days follow up of pulmonary embolism before and after starting PERT in our center |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate
mortality rate of pulmonary embolism
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start20 Jan 2025 (estimated)
- Primary completion17 Dec 2026 (estimated)
- Study completion17 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Embolism (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Abdelmoaz Farghaly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756373
- Sponsor's protocol ID
- mangement of pulmonary emboli
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gerardo F, Faria D, Silverio Antonio P, Baltazar Ferreira J, Beringuilho M, Ferreira H, Fialho I, Miranda I, Sa Pereira Y, Nunes-Ferreira A, Roque D, Santos MB, Morais C, Bravo Baptista S, Augusto JB. PrOgnosis in Pulmonary Embolism (PoPE): 30-Day mortality risk score based on five admission parameters. Rev Port Cardiol. 2024 Jan;43(1):1-8. doi: 10.1016/j.repc.2023.04.011. Epub 2023 Jul 7. English, Portuguese.
PubMed 37423312Leidi A, Bex S, Righini M, Berner A, Grosgurin O, Marti C. Risk Stratification in Patients with Acute Pulmonary Embolism: Current Evidence and Perspectives. J Clin Med. 2022 Apr 30;11(9):2533. doi: 10.3390/jcm11092533.
PubMed 35566658Cohen AT, Agnelli G, Anderson FA, Arcelus JI, Bergqvist D, Brecht JG, Greer IA, Heit JA, Hutchinson JL, Kakkar AK, Mottier D, Oger E, Samama MM, Spannagl M; VTE Impact Assessment Group in Europe (VITAE). Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thromb Haemost. 2007 Oct;98(4):756-64. doi: 10.1160/TH07-03-0212.
PubMed 17938798ISTH Steering Committee for World Thrombosis Day. Thrombosis: a major contributor to the global disease burden. J Thromb Haemost. 2014 Oct;12(10):1580-90. doi: 10.1111/jth.12698.
PubMed 25302663
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to International Guidelines Directed Risk Stratification and Management of Acute Pulmonary Embolism, an Egyptian Experience
- ClinicalTrials.gov ID
- NCT06756373
- Acronym / sponsor ID
- mangement of pulmonary emboli
- Conditions
- Pulmonary Embolism (Diagnosis)
- Keywords
- simplified pulmonary embolism l index, POPE
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 17 Dec 2026 (estimated)
- Study completion
- 17 Dec 2027 (estimated)
- First posted
- 3 Jan 2025 (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.
To assess to which extent we are adherent to ESC guidelines 2019 in management of patients presented with acute pulmonary embolism
Detailed description
Pulmonary embolism (PE) is the third most frequent cardiovascular disease and is associated with a high mortality burden PE is defined as the obstruction of a pulmonary artery, mostly resulting from the dislodgement of thrombotic material from the lower limbs. It has a wide variety of presentations, ranging from an asymptomatic incidental finding to circulatory collapse and sudden death Pulmonary embolism response teams (PERTs) have emerged as a multidisciplinary team for managing acute pulmonary embolism, with a rapid activation process for multimodality assessment, risk stratification and best management especially for complex challenge cases. PERTs help in improving time to PE diagnosis; shorter time to initiation of anticoagulation reducing hospital length of stay, increasing use of advanced therapies as catheter directed therapies without an increase in bleeding complications with decreasing mortality
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| To assess to which extent we are adherent to ESC guidelines 2019 in management of patients presented | – | –Comparing ESC 2019 criteria for risk stratification and mortality with new scores [BOVA , modified FAST, PEITHO-3 models \& POPE]. -Comparing management and outcomes of in hospital and 30 days follow up of pulmonary embolism before and after starting PERT in our center |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- treatment of patient with pulmonary embolism according to ECS Guidlines
Key inclusion criteria (1 listed)
- No includion criteria
Key exclusion criteria (1 listed)
- No exclusion criteria
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
mortality rate
Time frame: 30 day
mortality rate of pulmonary embolism
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Background: PubMed 37423312Gerardo F, Faria D, Silverio Antonio P, Baltazar Ferreira J, Beringuilho M, Ferreira H, Fialho I, Miranda I, Sa Pereira Y, Nunes-Ferreira A, Roque D, Santos MB, Morais C, Bravo Baptista S, Augusto JB. PrOgnosis in Pulmonary Embolism (PoPE): 30-Day mortality risk score based on five admission parameters. Rev Port Cardiol. 2024 Jan;43(1):1-8. doi: 10.1016/j.repc.2023.04.011. Epub 2023 Jul 7. English, Portuguese.
- Background: PubMed 35566658Leidi A, Bex S, Righini M, Berner A, Grosgurin O, Marti C. Risk Stratification in Patients with Acute Pulmonary Embolism: Current Evidence and Perspectives. J Clin Med. 2022 Apr 30;11(9):2533. doi: 10.3390/jcm11092533.
- Background: PubMed 17938798Cohen AT, Agnelli G, Anderson FA, Arcelus JI, Bergqvist D, Brecht JG, Greer IA, Heit JA, Hutchinson JL, Kakkar AK, Mottier D, Oger E, Samama MM, Spannagl M; VTE Impact Assessment Group in Europe (VITAE). Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thromb Haemost. 2007 Oct;98(4):756-64. doi: 10.1160/TH07-03-0212.
- Background: PubMed 25302663ISTH Steering Committee for World Thrombosis Day. Thrombosis: a major contributor to the global disease burden. J Thromb Haemost. 2014 Oct;12(10):1580-90. doi: 10.1111/jth.12698.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism (Diagnosis), run by Assiut University.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 3 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rania Abdelmoaz Farghaly, master student (+201284742238, raniaezz276@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality rate (time frame: 30 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06756373, which also lists 4 linked publications.
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 3 Jan 2025.