Risk Assessment Strategies in Pulmonary Embolism

March 28, 2020 updated by: Mariam louiz Azmy, Assiut University

Risk Stratification in Pulmonary Embolism

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hospital stay, need for ICU admission, need for mechanical ventilation or cardiopulmonary resuscitation or home dischage.
Time Frame: Baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

March 26, 2020

First Submitted That Met QC Criteria

March 28, 2020

First Posted (Actual)

March 31, 2020

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 28, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pulmonary embolism

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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