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Prognostic Tools in Patients With Acute Pulmonary Thromboembolism.

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ClinicalTrials.gov Identifier: NCT04237974
Recruitment Status : Not yet recruiting
First Posted : January 23, 2020
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Amal Abdallah Abd Elrahman, Assiut University

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

Condition or disease Intervention/treatment
Pulmonary Embolism Device: computed tomography pulmonary angiography

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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of Different Prognostic Tools in Patients With Acute Pulmonary Thromboembolism
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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)
    Other Name: echocardiography


Primary Outcome Measures :
  1. 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%).

  2. prognostic importance of White blood cell count(WBC) . [ Time Frame: 2 years ]
    • white blood cell count (number/cubic milliliter)

  3. prognostic importance of polymorphonuclear cell count [ Time Frame: 2 years ]
    -polymorphonuclear cell count (number/cubic milliliter)

  4. prognostic importance of lymphocyte cell count [ Time Frame: 2 years ]
    -lymphocyte cell count (number/cubic milliliter)

  5. prognostic importance of a D-dimer level [ Time Frame: 2 years ]
    - D-dimer level (microgram/liter)

  6. prognostic importance of Troponin level [ Time Frame: 2 years ]
    -Troponin level (nanogram/milliliter)

  7. prognostic importance of C-reactive protein [ Time Frame: 2 years ]
    - C-reactive protein (milligram /liter)

  8. prognostic importance of arterial blood gases while the patients are breathing room air. [ Time Frame: 2 years ]
    -Partial pressure of oxygen tension (millimeter mercury)

  9. prognostic importance of hemoglobin level [ Time Frame: 2 years ]
    -hemoglobin level (gram/deciliter)

  10. prognostic importance of platelet cell count [ Time Frame: 2 years ]
    -platelet cell count (number/cubic milliliter)

  11. prognostic importance of red cell distribution width [ Time Frame: 2 years ]
    -red cell distribution width (%)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients admitted at the Chest Department and Respiratory Intensive Care Unit (RICU) at Assiut University Hospital.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04237974


Contacts
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Contact: Amal A Abd Elrahman, MD 01067990873 ext +2 amalabdallah1490@yahoo.com

Sponsors and Collaborators
Assiut University

Publications:

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Responsible Party: Amal Abdallah Abd Elrahman, assistant lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT04237974    
Other Study ID Numbers: pulmonary embolism prognosis
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Embolism
Thromboembolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases