Prognostic Tools in Patients With Acute Pulmonary Thromboembolism.

NCT ID: NCT04237974

Last Updated: 2022-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-20

Study Completion Date

2023-10-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Pulmonary Embolism

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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computed tomography pulmonary angiography

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

Intervention Type DEVICE

Other Intervention Names

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echocardiography

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Amal Abdallah Abd Elrahman

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yousef A Yousef, Professor

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Assiut university hospital

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Amal A Abd Elrahman, MD

Role: CONTACT

01067990873 ext. +2

Facility Contacts

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Amal A Abd Elrahman, MD

Role: primary

01067990873

Yousef A Yousef, Professor

Role: backup

01025033083

References

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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.

Reference Type BACKGROUND
PMID: 17938798 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10227218 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17619833 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11992305 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11373204 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19525265 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22109384 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21218608 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29260572 (View on PubMed)

Other Identifiers

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pulmonary embolism prognosis

Identifier Type: -

Identifier Source: org_study_id

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