Prognostic Tools in Patients With Acute Pulmonary Thromboembolism.

Pulmonary Embolism Clinical Trial

Official title:

Evaluation of Different Prognostic Tools in Patients With Acute Pulmonary Thromboembolism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04237974
• Other study ID #: pulmonary embolism prognosis
• Status: Recruiting
• Start date: April 20, 2021
• Est. completion date: October 2023

Study information

• Verified date: March 2022
• Source: Assiut University
• Contact: Amal A Abd Elrahman, MD
• Phone: 01067990873
• Email: amalabdallah1490[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. Age less than 18 years.

2. Patients with known hematological disorders.

3. Patients with history of recent blood transfusion (within 3 weeks).

4. Patients receive anti-platelet and/or anticoagulant medications.

5. Patients receive immunosuppressive drugs.

6. Patients with known cardiopulmonary diseases other than the pulmonary embolism.

7. Patients with known active infectious diseases or immunological diseases

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism
• Thromboembolism

Intervention

Device:
• computed tomography pulmonary angiography
The radiological severity of pulmonary embolism will be assessed by using the computed tomography pulmonary arterial obstruction index (CT-PAOI)

Locations

Country	Name	City	State
Egypt	Assiut university hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (9)

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. — View Citation

Becattini C, Agnelli G. Acute pulmonary embolism: risk stratification in the emergency department. Intern Emerg Med. 2007 Jun;2(2):119-29. Epub 2007 Jul 9. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Goldhaber SZ. Echocardiography in the management of pulmonary embolism. Ann Intern Med. 2002 May 7;136(9):691-700. Review. — View Citation

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. Review. — View Citation

Qanadli SD, El Hajjam M, Vieillard-Baron A, Joseph T, Mesurolle B, Oliva VL, Barré 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prognostic importance of computed tomography pulmonary artery obstruction index (CT-PAOI)	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%).	2 years
Primary	prognostic importance of White blood cell count(WBC) .	white blood cell count (number/cubic milliliter)	2 years
Primary	prognostic importance of polymorphonuclear cell count	-polymorphonuclear cell count (number/cubic milliliter)	2 years
Primary	prognostic importance of lymphocyte cell count	-lymphocyte cell count (number/cubic milliliter)	2 years
Primary	prognostic importance of a D-dimer level	- D-dimer level (microgram/liter)	2 years
Primary	prognostic importance of Troponin level	-Troponin level (nanogram/milliliter)	2 years
Primary	prognostic importance of C-reactive protein	- C-reactive protein (milligram /liter)	2 years
Primary	prognostic importance of arterial blood gases while the patients are breathing room air.	-Partial pressure of oxygen tension (millimeter mercury)	2 years
Primary	prognostic importance of hemoglobin level	-hemoglobin level (gram/deciliter)	2 years
Primary	prognostic importance of platelet cell count	-platelet cell count (number/cubic milliliter)	2 years
Primary	prognostic importance of red cell distribution width	-red cell distribution width (%)	2 years