Pulmonary EmbolismNCT04327960
Risk Assessment Strategies in Pulmonary Embolism
An observational study of Pulmonary Embolism, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Cardiac troponin (cTn)
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- -
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Embolism
- Being tested
- Cardiac troponin (cTn)
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (1)
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start1 Sep 2021 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam louiz Azmy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327960
- Sponsor's protocol ID
- Pulmonary embolism
- Status last verified
- Mar 2020
- First submitted
- 26 Mar 2020
- Last updated
- 31 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26738514Hobohm 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.
PubMed 26743479
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratification in Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT04327960
- Acronym / sponsor ID
- Pulmonary embolism
- Conditions
- Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- -
- Complete history taking and clinical examination.
- Chest x-ray
- ECG and echocardiography.
- Arterial blood gases.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | – |
Primary outcome
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
1 secondary outcome
hospital stay, need for ICU admission, need for mechanical ventilation or cardiopulmonary resuscitation or home dischage.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Background: PubMed 26738514Jimenez 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.
- Background: PubMed 26743479Hobohm 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariam Louiz, Master (+2012885523082, mariamlouiz1990@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary embolism-related death (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04327960, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.