Risk Assessment Strategies in Pulmonary Embolism

Pulmonary Embolism Clinical Trial

Official title:

Risk Stratification in Pulmonary Embolism

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04327960
• Other study ID #: Pulmonary embolism
• Status: Not yet recruiting
• Start date: September 1, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: March 2020
• Source: Assiut University
• Contact: Mariam Louiz, Master
• Phone: +2012885523082
• Email: mariamlouiz1990[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to evaluate different scores of risk assessment in patients with pulmonary embolism. This study aim to compare the accuracy of these scores in predicting mortality during hospital admission.

Description:

Pulmonary embolism (PE) is a potentially life-threatening cardiovascular emergency with a high mortality rate.Approximately 1% of all hospitalized patients and 10% of all in-hospital mortalities are PE related. Adding to this, acute PE is linked to comparatively high (≥13%) short-term mortalities that occur either in hospital or within 30 days.

Some studies have demonstrated that PE may indicate increased 1-year mortality rates up to 25%,,. Therefore, PE is considered a potentially fatal disease, although patients who escape a PE-related death are still endangered by hematologic mishaps, especially recurrence of VTE and/or PE, or on the contrary, serious hemorrhage5.

Risk stratification of patients with acute PE is mandatory for determining the appropriate therapeutic management approach. Risk classification of PE can discriminate low-risk patients, who can be medicated as outpatients, from others at high risk, in whom a profit from intensive care unit admission or even in-hospital thrombolytic therapy is expected.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

-

All patients will be subjected to the following:

1. Complete history taking and clinical examination.

2. Chest x-ray

3. ECG and echocardiography.

4. Arterial blood gases.

5. Multislice CT angiography of the chest.

6. Laboratory tests and biomarkers.

Exclusion Criteria:

• 1- Patients with unexpected or accidental diagnosis of PE (patients undergoing diagnostic tests for another suspected disease.

2- Patients with acute left heart failure or acute respiratory failure responsible for symptoms.

3- Patient with recurrent PE (only the first event was included in the analysis).

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Diagnostic Test:
• Cardiac troponin (cTn)
Cardiac troponin (cTn) will be measured with the Dimension RxL-HM analyzer .The one-step enzyme immunoassay is based on cTn specific monoclonal antibodies, performed on a separate module of the analyzer, assay-time is 17 minutes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Hobohm L, Hellenkamp K, Hasenfuß G, Münzel T, Konstantinides S, Lankeit M. Comparison of risk assessment strategies for not-high-risk pulmonary embolism. Eur Respir J. 2016 Apr;47(4):1170-8. doi: 10.1183/13993003.01605-2015. Epub 2016 Jan 7. — View Citation

Jimenez D, Lobo JL, Fernandez-Golfin C, Portillo AK, Nieto R, Lankeit M, Konstantinides S, Prandoni P, Muriel A, Yusen RD; PROTECT investigators. Effectiveness of prognosticating pulmonary embolism using the ESC algorithm and the Bova score. Thromb Haemost. 2016 Apr;115(4):827-34. doi: 10.1160/TH15-09-0761. Epub 2016 Jan 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary embolism-related death	Approximately 1% of all hospitalized patients and 10% of all in-hospital mortalities are PE related. Adding to this, acute PE is linked to comparatively high (=13%) short-term mortalities that occur either in hospital or within 30 days	Baseline
Secondary	hospital stay, need for ICU admission, need for mechanical ventilation or cardiopulmonary resuscitation or home dischage.	patients who escape a PE-related death are still endangered by hematologic mishaps, especially recurrence of VTE and/or PE, or on the contrary, serious hemorrhage	Baseline