- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04237974
Prognostic Tools in Patients With Acute Pulmonary Thromboembolism.
Evaluation of Different Prognostic Tools in Patients With Acute Pulmonary Thromboembolism
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Acute pulmonary embolism (PE) is a serious disease associated with high mortality rates despite advanced therapeutic options. The treatment options depend on the severity of the disease and the short - term mortality varies widely from 2 to 95%, depending on the severity of the condition.
Initial risk stratification of patients with PE could be based on clinical indicators. The presence of shock and hypotension is the most important clinical sign of poor prognosis. Other clinical variables, associated with poor prognosis are age over 70 years, history of bed rest over five days, cancer, chronic obstructive pulmonary disease, renal failure, heart failure, and tachycardia .
Echocardiography represents the most useful imaging tool in everyday clinical practice to show right ventricular dysfunction (RVD) because of its noninvasive nature and relative low cost. RVD assessed on echocardiography has been described as one of the strongest predictor of early mortality in PE .
Currently, computed tomography pulmonary angiography (CTPA) represents the diagnostic gold standard for PE. Additionally, CTPA was used to evaluate the prognosis by determining the distribution and severity of vascular obstruction of clots in pulmonary circulation; this is called computed tomography pulmonary artery obstruction index (CT-PAOI). CTPA was also suggested as a predictor of RVD .
In addition to the clinical findings and the imaging abnormalities, there are several biomarkers and indicators that can be used to predict severity and prognosis in patients with PE. These biomarkers include troponin and brain natriuretic peptide (indicators of RVD and myocardial damage), D-dimer, C-reactive protein, arterial blood gases parameters and complete blood count (CBC) parameters. However, some of these biomarkers have not been widely studied and are not commonly used although they are readily available and cheaper for developing countries.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Amal A Abd Elrahman, MD
- Phone Number: +2 01067990873
- Email: amalabdallah1490@yahoo.com
Study Locations
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Assiut, Egypt, 71511
- Recruiting
- Assiut UNIVERSITY HOSPITAL
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Contact:
- Amal A Abd Elrahman, MD
- Phone Number: 01067990873
- Email: amalabdallah1490@yahoo.com
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Contact:
- Yousef A Yousef, Professor
- Phone Number: 01025033083
- Email: yousefahmad72@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults (≥ 18 years) who will be diagnosed as acute pulmonary embolism based on computed tomography pulmonary angiography (CTPA) and not yet treated.
Exclusion Criteria:
- Age less than 18 years.
- Patients with known hematological disorders.
- Patients with history of recent blood transfusion (within 3 weeks).
- Patients receive anti-platelet and/or anticoagulant medications.
- Patients receive immunosuppressive drugs.
- Patients with known cardiopulmonary diseases other than the pulmonary embolism.
- Patients with known active infectious diseases or immunological diseases
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prognostic importance of computed tomography pulmonary artery obstruction index (CT-PAOI)
Time Frame: 2 years
|
To calculate the CT-PAOI, the arterial tree of each lung was considered to have 10 segmental arteries .
The presence of an embolus in a segmental artery was scored 1 point.
Central or paracentral emboli were scored a value equal to the number of segmental arteries arising distally.
Depending on the degree of vascular obstruction a weighting factor was assigned to each value (0, no thrombus 1, partial occlusion and 2, total occlusion).
Isolated subsegmental embolus was considered as a partially occluded segmental artery and was assigned a value of1.
Thus, the PAOI could vary from 1 to 40 points per patient.
Dividing the patient score by the maximal total score and multiplying the result by 100 calculated the percentage of vascular obstruction, Based on the which, patients were then divided into three groups (<15% versus 15-50% versus >50%).
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2 years
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prognostic importance of White blood cell count(WBC) .
Time Frame: 2 years
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2 years
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prognostic importance of polymorphonuclear cell count
Time Frame: 2 years
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-polymorphonuclear cell count (number/cubic milliliter)
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2 years
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prognostic importance of lymphocyte cell count
Time Frame: 2 years
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-lymphocyte cell count (number/cubic milliliter)
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2 years
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prognostic importance of a D-dimer level
Time Frame: 2 years
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- D-dimer level (microgram/liter)
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2 years
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prognostic importance of Troponin level
Time Frame: 2 years
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-Troponin level (nanogram/milliliter)
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2 years
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prognostic importance of C-reactive protein
Time Frame: 2 years
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- C-reactive protein (milligram /liter)
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2 years
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prognostic importance of arterial blood gases while the patients are breathing room air.
Time Frame: 2 years
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-Partial pressure of oxygen tension (millimeter mercury)
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2 years
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prognostic importance of hemoglobin level
Time Frame: 2 years
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-hemoglobin level (gram/deciliter)
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2 years
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prognostic importance of platelet cell count
Time Frame: 2 years
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-platelet cell count (number/cubic milliliter)
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2 years
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prognostic importance of red cell distribution width
Time Frame: 2 years
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-red cell distribution width (%)
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2 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yousef A Yousef, Professor, Assiut University
Publications and helpful links
General Publications
- Qanadli SD, El Hajjam M, Vieillard-Baron A, Joseph T, Mesurolle B, Oliva VL, Barre O, Bruckert F, Dubourg O, Lacombe P. New CT index to quantify arterial obstruction in pulmonary embolism: comparison with angiographic index and echocardiography. AJR Am J Roentgenol. 2001 Jun;176(6):1415-20. doi: 10.2214/ajr.176.6.1761415.
- Cohen 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.
- Goldhaber SZ, Visani L, De Rosa M. Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER). Lancet. 1999 Apr 24;353(9162):1386-9. doi: 10.1016/s0140-6736(98)07534-5.
- Becattini C, Agnelli G. Acute pulmonary embolism: risk stratification in the emergency department. Intern Emerg Med. 2007 Jun;2(2):119-29. doi: 10.1007/s11739-007-0033-y. Epub 2007 Jul 9.
- Goldhaber SZ. Echocardiography in the management of pulmonary embolism. Ann Intern Med. 2002 May 7;136(9):691-700. doi: 10.7326/0003-4819-136-9-200205070-00012.
- Lega JC, Lacasse Y, Lakhal L, Provencher S. Natriuretic peptides and troponins in pulmonary embolism: a meta-analysis. Thorax. 2009 Oct;64(10):869-75. doi: 10.1136/thx.2008.110965. Epub 2009 Jun 11.
- Becattini C, Lignani A, Masotti L, Forte MB, Agnelli G. D-dimer for risk stratification in patients with acute pulmonary embolism. J Thromb Thrombolysis. 2012 Jan;33(1):48-57. doi: 10.1007/s11239-011-0648-8.
- Abul Y, Karakurt S, Ozben B, Toprak A, Celikel T. C-reactive protein in acute pulmonary embolism. J Investig Med. 2011 Jan;59(1):8-14. doi: 10.2310/jim.0b013e31820017f2.
- Subramanian M, Ramadurai S, Arthur P, Gopalan S. Hypoxia as an independent predictor of adverse outcomes in pulmonary embolism. Asian Cardiovasc Thorac Ann. 2018 Jan;26(1):38-43. doi: 10.1177/0218492317746252. Epub 2017 Dec 20.
Study record dates
Study Major Dates
Study Start (ACTUAL)
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
- pulmonary embolism prognosis
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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