Risk Assessment Strategies in Pulmonary Embolism

NCT04327960 | Unknown

• 1 other identifier: Pulmonary embolism
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• hospital stay, need for ICU admission, need for mechanical ventilation or cardiopulmonary resuscitation or home dischage.

  Baseline

Interventions

Cardiac troponin (cTn) DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The present study is a cross-sectional study. All patients consecutively admitted to Assuit University Hospital, diagnosid with PE will be included. At least 80 patients will be included in the present study. Sample size was calculated using Epi- Info version 7, based on a previous study conducted by Yousif and Hussein (2019), which demonstrated that the mortality rate from pulmonary embolism was 13.7%, with a confidence limit of 5% and a confidence level of 80%. To overcome the dropouts the sample may be extended to 100 patients.

You may qualify if:

• All patients will be subjected to the following:
• Complete history taking and clinical examination.
• Chest x-ray
• ECG and echocardiography.
• Arterial blood gases.
• Multislice CT angiography of the chest.
• Laboratory tests and biomarkers.

You may not qualify if:

• Patients with unexpected or accidental diagnosis of PE (patients undergoing diagnostic tests for another suspected disease.
• Patients with acute left heart failure or acute respiratory failure responsible for symptoms.
• Patient with recurrent PE (only the first event was included in the analysis).

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• 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.

  PMID: 26738514 BACKGROUND

• Hobohm L, Hellenkamp K, Hasenfuss G, Munzel 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.

  PMID: 26743479 BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mariam Louiz, Master

CONTACT

+2012885523082; mariamlouiz1990@gmail.com

Study Design

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

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 31, 2020
• Study Start: September 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: October 1, 2023
• Last Updated: March 31, 2020

Record last verified: 2020-03