Prognostic Tools in Patients With Acute Pulmonary Thromboembolism.

NCT04237974 | Unknown

• 1 other identifier: pulmonary embolism prognosis
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (11)

• 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

• prognostic importance of White blood cell count(WBC) .

  * white blood cell count (number/cubic milliliter)

  2 years

• prognostic importance of polymorphonuclear cell count

  -polymorphonuclear cell count (number/cubic milliliter)

  2 years

• prognostic importance of lymphocyte cell count

  -lymphocyte cell count (number/cubic milliliter)

  2 years

• prognostic importance of a D-dimer level

  \- D-dimer level (microgram/liter)

  2 years

• prognostic importance of Troponin level

  -Troponin level (nanogram/milliliter)

  2 years

• prognostic importance of C-reactive protein

  \- C-reactive protein (milligram /liter)

  2 years

• prognostic importance of arterial blood gases while the patients are breathing room air.

  -Partial pressure of oxygen tension (millimeter mercury)

  2 years

• prognostic importance of hemoglobin level

  -hemoglobin level (gram/deciliter)

  2 years

• prognostic importance of platelet cell count

  -platelet cell count (number/cubic milliliter)

  2 years

• prognostic importance of red cell distribution width

  -red cell distribution width (%)

  2 years

Interventions

computed tomography pulmonary angiography DEVICE

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

Also known as: echocardiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients admitted at the Chest Department and Respiratory Intensive Care Unit (RICU) at Assiut University Hospital.

You may qualify if:

• Adults (≥ 18 years) who will be diagnosed as acute pulmonary embolism based on computed tomography pulmonary angiography (CTPA) and not yet treated.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, 71511, Egypt

RECRUITING

Related Publications (9)

• 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. doi: 10.1160/TH07-03-0212.

  PMID: 17938798 BACKGROUND

• 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.

  PMID: 10227218 BACKGROUND

• 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.

  PMID: 17619833 BACKGROUND

• 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.

  PMID: 11992305 BACKGROUND

• 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.

  PMID: 11373204 BACKGROUND

• 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.

  PMID: 19525265 BACKGROUND

• 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.

  PMID: 22109384 BACKGROUND

• 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.

  PMID: 21218608 BACKGROUND

• 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.

  PMID: 29260572 BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Yousef A Yousef, Professor

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amal A Abd Elrahman, MD

CONTACT

01067990873; amalabdallah1490@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 23, 2020
• Study Start: April 20, 2021
• Primary Completion: April 1, 2023
• Study Completion: October 1, 2023
• Last Updated: April 1, 2022

Record last verified: 2022-03

Locations

EG (1)