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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05469724
Other study ID # Clinical of acute pulm emb
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 2022
Est. completion date December 2023

Study information

Verified date April 2022
Source Assiut University
Contact Peter samir roshdy Poles, Master
Phone 01097150423
Email peposamir781@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 2023
Est. primary completion date October 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Patients above 18 years old and less than 75 year old Exclusion Criteria: - patients with chronic thromboembolism _patient less than 18 years old

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Role of ct pulmonary angiography in diagnosis of pulmonary embolism
Role of ct pulmonary angiography in diagnosis of acute pulmonary embolism as filling defect in pulmonary artery

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (5)

Hepburn-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. Review. — View Citation

Howard L. Acute pulmonary embolism. Clin Med (Lond). 2019 May;19(3):243-247. doi: 10.7861/clinmedicine.19-3-247. Review. Erratum in: Clin Med (Lond). 2019 Jul;19(4):359. — View Citation

Righini 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. Review. — View Citation

Rivera-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. — View Citation

Sin 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 year
Secondary Pulmonary embolism severity index risk score and its units of measurement Classification of patients according to rik score of pulmonary embolism severity index 1 year
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