Acute Pulmonary EmbolismNCT05469724
Clinical Pulmonary Embolism
An observational study of Acute Pulmonary Embolism, run by Assiut University.
Trial summary
To evaluate the clinical characteristics, risk factors, management and outcome of patients admitted e acute pulmonary embolism in chest diseases department and Respiratory Icu in Assiut University hospital Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pulmonary Embolism
- What is being tested?
- Role of ct pulmonary angiography in diagnosis of pulmonary embolism
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Dec 2023
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study of patient between 18and 75 year presented by acute pulmonary embolism
Who may be able to join
- Patients above 18 years old and less than 75 year old
Who cannot join
- patients with chronic thromboembolism _patient less than 18 years old
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Characteristics and Outcome Registry in Patients Admitted With Acute Pulmonary Embolism
To evaluate the clinical characteristics, risk factors, management and outcome of patients admitted e acute pulmonary embolism in chest diseases department and Respiratory Icu in Assiut University hospital
Read the detailed description
Pulmonary embolism (PE) occurs when there is a disruption to the flow of blood in the pulmonary artery or its branches by a thrombus that originated somewhere else. In deep vein thrombosis (DVT), a thrombus develops within the deep veins, most commonly in the lower extremities. PE usually occurs when a part of this thrombus breaks off and enters the pulmonary circulation. Very rarely, PE can occur from the embolization of other materials into the pulmonary circulation such as air, fat, or tumor cells.Risk factors can be classified as genetic and acquired. Genetic risk factors include thrombophilia such as factor V Leiden mutation, prothrombin gene mutation, protein C deficiency, protein S deficiency, hyperhomocysteinemia, among others. Acquired risk factors include immobilization for prolonged periods (bed rest greater than three days, anyone traveling greater than 4 hours, whether by air, car, bus, or train), recent orthopedic surgery, malignancy, indwelling venous catheter, obesity, pregnancy, cigarette smoking, oral contraceptive pill use
Other predisposing factors for VTE include:
Fracture of lower limb Hospitalization for heart failure or atrial fibrillation/flutter within the previous three months Hip or knee replacement Major trauma History of previous venous thromboembolism Central venous lines Chemotherapy Congestive heart failure or respiratory failure Hormone replacement therapy Oral contraceptive therapy Postpartum period Infection (specifically pneumonia, urinary tract infection, and HIV) Cancer (highest risk in metastatic disease) Thrombophilia Bed rest greater than three days Obesity Pregnancy Cancer carries a high risk for thrombus formation and hence, PE. Pancreatic cancer, hematological malignancies, lung cancer, gastric cancer, and brain cancer carry the highest risk for VTThe most common symptoms of PE include the following: dyspnea, pleuritic chest pain, cough, hemoptysis, presyncope, or syncope. Dyspnea may be acute and severe in central PE, whereas it is often mild and transient in small peripheral PE. In patients with preexisting heart failure or pulmonary disease, worsening dyspnea may be the only symptom. Chest pain is a frequent symptom and is usually caused by pleural irritation due to distal emboli causing pulmonary infarction.
- Conditions
- Acute Pulmonary Embolism
- Being tested
- Role of ct pulmonary angiography in diagnosis of pulmonary embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Role of ct pulmonary angiography in diagnosis of pulmonary embolismOther
Role of ct pulmonary angiography in diagnosis of acute pulmonary embolism as filling defect in pulmonary artery
What is being measured
The primary outcome is the main question the study is designed to answer.
European society of cardiology risk score and its measurement units
Classification of patients admitted with acute pulmonary embolism into high risk ,low risk, intermediate high and intermediate low risk
Measured: 1 year
Secondary outcomes (1)
Pulmonary embolism severity index risk score and its units of measurement
Classification of patients according to rik score of pulmonary embolism severity index
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study startJul 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Pulmonary EmbolismStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Samir Roshdy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469724
- Sponsor's protocol ID
- Clinical of acute pulm emb
- Status last verified
- Apr 2022
- First submitted
- 1 Jun 2022
- Last updated
- 22 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Howard L. Acute pulmonary embolism. Clin Med (Lond). 2019 May;19(3):243-247. doi: 10.7861/clinmedicine.19-3-247.
PubMed 31092519Hepburn-Brown M, Darvall J, Hammerschlag G. Acute pulmonary embolism: a concise review of diagnosis and management. Intern Med J. 2019 Jan;49(1):15-27. doi: 10.1111/imj.14145.
PubMed 30324770Rivera-Lebron B, McDaniel M, Ahrar K, Alrifai A, Dudzinski DM, Fanola C, Blais D, Janicke D, Melamed R, Mohrien K, Rozycki E, Ross CB, Klein AJ, Rali P, Teman NR, Yarboro L, Ichinose E, Sharma AM, Bartos JA, Elder M, Keeling B, Palevsky H, Naydenov S, Sen P, Amoroso N, Rodriguez-Lopez JM, Davis GA, Rosovsky R, Rosenfield K, Kabrhel C, Horowitz J, Giri JS, Tapson V, Channick R; PERT Consortium. Diagnosis, Treatment and Follow Up of Acute Pulmonary Embolism: Consensus Practice from the PERT Consortium. Clin Appl Thromb Hemost. 2019 Jan-Dec;25:1076029619853037. doi: 10.1177/1076029619853037.
PubMed 31185730Righini M, Robert-Ebadi H. Diagnosis of acute Pulmonary Embolism. Hamostaseologie. 2018 Feb;38(1):11-21. doi: 10.5482/HAMO-17-07-0023. Epub 2018 Feb 26.
PubMed 29536476Sin D, McLennan G, Rengier F, Haddadin I, Heresi GA, Bartholomew JR, Fink MA, Thompson D, Partovi S. Acute pulmonary embolism multimodality imaging prior to endovascular therapy. Int J Cardiovasc Imaging. 2021 Jan;37(1):343-358. doi: 10.1007/s10554-020-01980-9. Epub 2020 Aug 30.
PubMed 32862293
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Outcome Registry in Patients Admitted With Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT05469724
- Acronym / sponsor ID
- Clinical of acute pulm emb
- Conditions
- Acute Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 22 Jul 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.
To evaluate the clinical characteristics, risk factors, management and outcome of patients admitted e acute pulmonary embolism in chest diseases department and Respiratory Icu in Assiut University hospital
Detailed description
Pulmonary embolism (PE) occurs when there is a disruption to the flow of blood in the pulmonary artery or its branches by a thrombus that originated somewhere else. In deep vein thrombosis (DVT), a thrombus develops within the deep veins, most commonly in the lower extremities. PE usually occurs when a part of this thrombus breaks off and enters the pulmonary circulation. Very rarely, PE can occur from the embolization of other materials into the pulmonary circulation such as air, fat, or tumor cells.Risk factors can be classified as genetic and acquired. Genetic risk factors include thrombophilia such as factor V Leiden mutation, prothrombin gene mutation, protein C deficiency, protein S deficiency, hyperhomocysteinemia, among others. Acquired risk factors include immobilization for prolonged periods (bed rest greater than three days, anyone traveling greater than 4 hours, whether by air, car, bus, or train), recent orthopedic surgery, malignancy, indwelling venous catheter, obesity, pregnancy, cigarette smoking, oral contraceptive pill use
Other predisposing factors for VTE include:
Fracture of lower limb Hospitalization for heart failure or atrial fibrillation/flutter within the previous three months Hip or knee replacement Major trauma History of previous venous thromboembolism Central venous lines Chemotherapy Congestive heart failure or respiratory failure Hormone replacement therapy Oral contraceptive therapy Postpartum period Infection (specifically pneumonia, urinary tract infection, and HIV) Cancer (highest risk in metastatic disease) Thrombophilia Bed rest greater than three days Obesity Pregnancy Cancer carries a high risk for thrombus formation and hence, PE. Pancreatic cancer, hematological malignancies, lung cancer, gastric cancer, and brain cancer carry the highest risk for VTThe most common symptoms of PE include the following: dyspnea, pleuritic chest pain, cough, hemoptysis, presyncope, or syncope. Dyspnea may be acute and severe in central PE, whereas it is often mild and transient in small peripheral PE. In patients with preexisting heart failure or pulmonary disease, worsening dyspnea may be the only symptom. Chest pain is a frequent symptom and is usually caused by pleural irritation due to distal emboli causing pulmonary infarction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study of patient between 18and 75 year presented by acute pulmonary embolism
Key inclusion criteria (1 listed)
- Patients above 18 years old and less than 75 year old
Key exclusion criteria (1 listed)
- patients with chronic thromboembolism _patient less than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Role of ct pulmonary angiography in diagnosis of pulmonary embolismRole of ct pulmonary angiography in diagnosis of acute pulmonary embolism as filling defect in pulmonary artery | Other | – |
Primary outcome
European society of cardiology risk score and its measurement units
Time frame: 1 year
Classification of patients admitted with acute pulmonary embolism into high risk ,low risk, intermediate high and intermediate low risk
1 secondary outcome
Pulmonary embolism severity index risk score and its units of measurement
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Background: PubMed 31092519Howard L. Acute pulmonary embolism. Clin Med (Lond). 2019 May;19(3):243-247. doi: 10.7861/clinmedicine.19-3-247.
- Background: PubMed 30324770Hepburn-Brown M, Darvall J, Hammerschlag G. Acute pulmonary embolism: a concise review of diagnosis and management. Intern Med J. 2019 Jan;49(1):15-27. doi: 10.1111/imj.14145.
- Background: PubMed 31185730Rivera-Lebron B, McDaniel M, Ahrar K, Alrifai A, Dudzinski DM, Fanola C, Blais D, Janicke D, Melamed R, Mohrien K, Rozycki E, Ross CB, Klein AJ, Rali P, Teman NR, Yarboro L, Ichinose E, Sharma AM, Bartos JA, Elder M, Keeling B, Palevsky H, Naydenov S, Sen P, Amoroso N, Rodriguez-Lopez JM, Davis GA, Rosovsky R, Rosenfield K, Kabrhel C, Horowitz J, Giri JS, Tapson V, Channick R; PERT Consortium. Diagnosis, Treatment and Follow Up of Acute Pulmonary Embolism: Consensus Practice from the PERT Consortium. Clin Appl Thromb Hemost. 2019 Jan-Dec;25:1076029619853037. doi: 10.1177/1076029619853037.
- Background: PubMed 29536476Righini M, Robert-Ebadi H. Diagnosis of acute Pulmonary Embolism. Hamostaseologie. 2018 Feb;38(1):11-21. doi: 10.5482/HAMO-17-07-0023. Epub 2018 Feb 26.
- Background: PubMed 32862293Sin D, McLennan G, Rengier F, Haddadin I, Heresi GA, Bartholomew JR, Fink MA, Thompson D, Partovi S. Acute pulmonary embolism multimodality imaging prior to endovascular therapy. Int J Cardiovasc Imaging. 2021 Jan;37(1):343-358. doi: 10.1007/s10554-020-01980-9. Epub 2020 Aug 30.
- Related InfoLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pulmonary Embolism, 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: status not confirmed, as of the sponsor's last update on 22 Jul 2022. 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 Peter samir roshdy Poles, Master (01097150423, peposamir781@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
European society of cardiology risk score and its measurement units (time frame: 1 year). 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 NCT05469724, which also lists 5 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 22 Jul 2022; AzTrials last refreshed its copy on 3 Nov 2026.