Risk Assessment Strategies in Pulmonary Embolism

NCT ID: NCT04327960

Last Updated: 2020-03-31

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

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-10-01

Brief Summary

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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.

Detailed Description

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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.

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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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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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Mariam louiz Azmy

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mariam Louiz, Master

Role: CONTACT

Phone: +2012885523082

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 26738514 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26743479 (View on PubMed)

Other Identifiers

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Pulmonary embolism

Identifier Type: -

Identifier Source: org_study_id