- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05469724
Clinical Pulmonary Embolism
Clinical Characteristics and Outcome Registry in Patients Admitted With Acute Pulmonary Embolism
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Peter samir roshdy Poles, Master
- Phone Number: 01097150423
- Email: peposamir781@gmail.com
Study Contact Backup
- Name: Safaa mokhtar wafy Wafy
- Phone Number: +20 122 414 2884
- Email: safaa_wafy@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pulmonary embolism severity index risk score and its units of measurement
Time Frame: 1 year
|
Classification of patients according to rik score of pulmonary embolism severity index
|
1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Howard L. Acute pulmonary embolism. Clin Med (Lond). 2019 May;19(3):243-247. doi: 10.7861/clinmedicine.19-3-247. Erratum In: Clin Med (Lond). 2019 Jul;19(4):359.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Clinical of acute pulm emb
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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