AzTrials
AzTrials

Pulmonary EmbolismNCT04237974

Prognostic Tools in Patients With Acute Pulmonary Thromboembolism.

An observational study of Pulmonary Embolism, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Embolism
What is being tested?
computed tomography pulmonary angiography
Type of treatment
Medical device
How many people
80 participants
Where
1 siteEgypt
Study dates
20 Apr 2021to Oct 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Amal A Abd Elrahman, MD contact

01067990873 ext. +2

amalabdallah1490@yahoo.com

Egypt1 site, 1 recruiting

  • Assiut university hospital

    Asyut, 71511

    Amal A Abd Elrahman, MD, 01067990873, amalabdallah1490@yahoo.com

    Yousef A Yousef, Professor, 01025033083, yousefahmad72@yahoo.com

    Recruiting

Other trials in Egypt

About this study

Official title: Evaluation of Different Prognostic Tools in Patients With Acute Pulmonary Thromboembolism

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

Read the 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.

Being tested
computed tomography pulmonary angiography
Medical subject headings
Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • computed tomography pulmonary angiographyDevice

    Also called echocardiography

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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%).

    Measured: 2 years

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

    • white blood cell count (number/cubic milliliter)

    Measured: 2 years

  3. prognostic importance of polymorphonuclear cell count

    -polymorphonuclear cell count (number/cubic milliliter)

    Measured: 2 years

  4. prognostic importance of lymphocyte cell count

    -lymphocyte cell count (number/cubic milliliter)

    Measured: 2 years

  5. prognostic importance of a D-dimer level

    • D-dimer level (microgram/liter)

    Measured: 2 years

  6. prognostic importance of Troponin level

    -Troponin level (nanogram/milliliter)

    Measured: 2 years

  7. prognostic importance of C-reactive protein

    • C-reactive protein (milligram /liter)

    Measured: 2 years

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

    -Partial pressure of oxygen tension (millimeter mercury)

    Measured: 2 years

  9. prognostic importance of hemoglobin level

    -hemoglobin level (gram/deciliter)

    Measured: 2 years

  10. prognostic importance of platelet cell count

    -platelet cell count (number/cubic milliliter)

    Measured: 2 years

  11. prognostic importance of red cell distribution width

    -red cell distribution width (%)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2020
  2. Study start20 Apr 2021
  3. Primary completionApr 2023 (estimated)
  4. Study completionOct 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04237974
Sponsor's protocol ID
pulmonary embolism prognosis
Status last verified
Mar 2022
First submitted
9 Jan 2020
Last updated
1 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 17938798

  • 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.

    PubMed 10227218

  • 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.

    PubMed 17619833

  • 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.

    PubMed 11992305

  • 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.

    PubMed 11373204

  • 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.

    PubMed 19525265

  • 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.

    PubMed 22109384

  • 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.

    PubMed 21218608

  • 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.

    PubMed 29260572

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Embolism, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Amal A Abd Elrahman, MD (01067990873 ext. +2, amalabdallah1490@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

prognostic importance of computed tomography pulmonary artery obstruction index (CT-PAOI) (time frame: 2 years). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04237974, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in