Pulmonary EmbolismNCT05613855
Performance of Pulmonary Embolism Risk Scores Out Come in CTPA Confirmed Patients
An observational study of Pulmonary Embolism, run by Assiut University.
Trial summary
1. Assess performance of PERFORM score in predicting outcome in CTPA confirmed patients. 2. Compare PERFORM score with the currently validated PESI in risk stratification of patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2022to Apr 2024
- 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 years and older
- All sexes
- Adult, Older adult
Study population: The study will be on patients wh are above 18 years okd who are daignosed to have pulmonary embolism with CTPA
Who may be able to join
- Patients above 18 years old with PE confirmed by CTPA are considered for inclusion in the study.
Who cannot join
- • Patients who have contraindications for CTPA eg. Renal impairment
- Patients diagnosed and treated as PE without doing CTPA.
- Patients who refuse to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Performance of Pulmonary Embolism Risk Scores for Assessment of Outcome in Computed Tomographic Pulmonary Angiography Confirmed Patients
- Assess performance of PERFORM score in predicting outcome in CTPA confirmed patients.
- Compare PERFORM score with the currently validated PESI in risk stratification of patients
Read the detailed description
Pulmonary embolism (PE) is a common and potentially lethal condition in the emergency department requiring early and accurate management.
The short-term mortality rate of PE varies widely and ranges from less than 2% in many patients with non massive PE to more than 95% in patients who experience cardiorespiratory arrest.
Although several prognostic models of acute PE are currently used, all of them have practical limitations.
Of all clinical scores integrating PE severity and comorbidity, the Pulmonary Embolism Severity Index (PESI) and its simplified version,(sPESI) have been most extensively validated to date.
However, current prognostic scores for pulmonary embolism (PE) are partly based on patients without PE confirmation via computed tomographic pulmonary angiography (CTPA), involving subjective parameters and complicated scoring methods [8].
Therefore, an objective, accurate, and simple prognostic model in CTPA-confirmed patients to predict the risk of 30-day mortality. help clinicians assess patients' risks and improve therapeutic decision-making that is called PERFORM score (pulmonary embolism risk score for mortality)
- Conditions
- Pulmonary Embolism
- Medical subject headings
- Pulmonary Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess performance of PERFORM score in predicting outcome in CTPA confirmed patients.
Measured: from 11/2022 to 4/2024
Secondary outcomes (1)
Compare PERFORM score with the currently validated PESI in risk stratification of patients.
Measured: from 11/2022 to 4/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study startNov 2022 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Safwat Abdelraheem Hussien, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613855
- Sponsor's protocol ID
- performance score outcome
- Status last verified
- Nov 2022
- First submitted
- 7 Nov 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Anderson FA Jr, Wheeler HB, Goldberg RJ, Hosmer DW, Patwardhan NA, Jovanovic B, Forcier A, Dalen JE. A population-based perspective of the hospital incidence and case-fatality rates of deep vein thrombosis and pulmonary embolism. The Worcester DVT Study. Arch Intern Med. 1991 May;151(5):933-8.
PubMed 2025141Kurkciyan I, Meron G, Sterz F, Janata K, Domanovits H, Holzer M, Berzlanovich A, Bankl HC, Laggner AN. Pulmonary embolism as a cause of cardiac arrest: presentation and outcome. Arch Intern Med. 2000 May 22;160(10):1529-35. doi: 10.1001/archinte.160.10.1529.
PubMed 10826469Jimenez D, Aujesky D, Moores L, Gomez V, Lobo JL, Uresandi F, Otero R, Monreal M, Muriel A, Yusen RD; RIETE Investigators. Simplification of the pulmonary embolism severity index for prognostication in patients with acute symptomatic pulmonary embolism. Arch Intern Med. 2010 Aug 9;170(15):1383-9. doi: 10.1001/archinternmed.2010.199.
PubMed 20696966Elias A, Mallett S, Daoud-Elias M, Poggi JN, Clarke M. Prognostic models in acute pulmonary embolism: a systematic review and meta-analysis. BMJ Open. 2016 Apr 29;6(4):e010324. doi: 10.1136/bmjopen-2015-010324.
PubMed 27130162Agnelli G, Becattini C. Acute pulmonary embolism. N Engl J Med. 2010 Jul 15;363(3):266-74. doi: 10.1056/NEJMra0907731. Epub 2010 Jun 30. No abstract available.
PubMed 20592294Yu S, Zhou H, Li Y, Song J, Shao J, Wang X, Xie Z, Qiu C, Sun K. PERFORM: Pulmonary embolism risk score for mortality in computed tomographic pulmonary angiography-confirmed patients. EClinicalMedicine. 2021 May 31;36:100897. doi: 10.1016/j.eclinm.2021.100897. eCollection 2021 Jun.
PubMed 34136775
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Pulmonary Embolism Risk Scores for Assessment of Outcome in Computed Tomographic Pulmonary Angiography Confirmed Patients
- ClinicalTrials.gov ID
- NCT05613855
- Acronym / sponsor ID
- performance score outcome
- Conditions
- Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 14 Nov 2022 (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.
- Assess performance of PERFORM score in predicting outcome in CTPA confirmed patients.
- Compare PERFORM score with the currently validated PESI in risk stratification of patients
Detailed description
Pulmonary embolism (PE) is a common and potentially lethal condition in the emergency department requiring early and accurate management.
The short-term mortality rate of PE varies widely and ranges from less than 2% in many patients with non massive PE to more than 95% in patients who experience cardiorespiratory arrest.
Although several prognostic models of acute PE are currently used, all of them have practical limitations.
Of all clinical scores integrating PE severity and comorbidity, the Pulmonary Embolism Severity Index (PESI) and its simplified version,(sPESI) have been most extensively validated to date.
However, current prognostic scores for pulmonary embolism (PE) are partly based on patients without PE confirmation via computed tomographic pulmonary angiography (CTPA), involving subjective parameters and complicated scoring methods [8].
Therefore, an objective, accurate, and simple prognostic model in CTPA-confirmed patients to predict the risk of 30-day mortality. help clinicians assess patients' risks and improve therapeutic decision-making that is called PERFORM score (pulmonary embolism risk score for mortality)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study will be on patients wh are above 18 years okd who are daignosed to have pulmonary embolism with CTPA
Key inclusion criteria (1 listed)
- Patients above 18 years old with PE confirmed by CTPA are considered for inclusion in the study.
Key exclusion criteria (3 listed)
- • Patients who have contraindications for CTPA eg. Renal impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess performance of PERFORM score in predicting outcome in CTPA confirmed patients.
Time frame: from 11/2022 to 4/2024
1 secondary outcome
Compare PERFORM score with the currently validated PESI in risk stratification of patients.
Time frame: from 11/2022 to 4/2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Results publication: PubMed 2025141Anderson FA Jr, Wheeler HB, Goldberg RJ, Hosmer DW, Patwardhan NA, Jovanovic B, Forcier A, Dalen JE. A population-based perspective of the hospital incidence and case-fatality rates of deep vein thrombosis and pulmonary embolism. The Worcester DVT Study. Arch Intern Med. 1991 May;151(5):933-8.
- Results publication: PubMed 10826469Kurkciyan I, Meron G, Sterz F, Janata K, Domanovits H, Holzer M, Berzlanovich A, Bankl HC, Laggner AN. Pulmonary embolism as a cause of cardiac arrest: presentation and outcome. Arch Intern Med. 2000 May 22;160(10):1529-35. doi: 10.1001/archinte.160.10.1529.
- Results publication: PubMed 20696966Jimenez D, Aujesky D, Moores L, Gomez V, Lobo JL, Uresandi F, Otero R, Monreal M, Muriel A, Yusen RD; RIETE Investigators. Simplification of the pulmonary embolism severity index for prognostication in patients with acute symptomatic pulmonary embolism. Arch Intern Med. 2010 Aug 9;170(15):1383-9. doi: 10.1001/archinternmed.2010.199.
- Results publication: PubMed 27130162Elias A, Mallett S, Daoud-Elias M, Poggi JN, Clarke M. Prognostic models in acute pulmonary embolism: a systematic review and meta-analysis. BMJ Open. 2016 Apr 29;6(4):e010324. doi: 10.1136/bmjopen-2015-010324.
- Results publication: PubMed 20592294Agnelli G, Becattini C. Acute pulmonary embolism. N Engl J Med. 2010 Jul 15;363(3):266-74. doi: 10.1056/NEJMra0907731. Epub 2010 Jun 30. No abstract available.
- Results publication: PubMed 34136775Yu S, Zhou H, Li Y, Song J, Shao J, Wang X, Xie Z, Qiu C, Sun K. PERFORM: Pulmonary embolism risk score for mortality in computed tomographic pulmonary angiography-confirmed patients. EClinicalMedicine. 2021 May 31;36:100897. doi: 10.1016/j.eclinm.2021.100897. eCollection 2021 Jun.
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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 1 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 14 Nov 2022. 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 Nourhan Safwat Abdelraheem, resiedent doctor (01067885766, nourhansafwat22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess performance of PERFORM score in predicting outcome in CTPA confirmed patients. (time frame: from 11/2022 to 4/2024). 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 NCT05613855, which also lists 6 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 14 Nov 2022.