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Clinical Trials/NCT04327960
NCT04327960UnknownNot Applicable

Risk Stratification in Pulmonary Embolism

Assiut University0 sites100 target enrollmentStarted: September 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Primary Endpoint
Pulmonary embolism-related death

Study Overview

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.

Detailed 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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

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).

Outcomes

Primary Outcomes

Pulmonary embolism-related death

Time Frame: Baseline

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

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mariam louiz Azmy

Physician

Assiut University

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