Performance of Pulmonary Embolism Risk Scores Out Come in CTPA Confirmed Patients

Pulmonary Embolism Clinical Trial

Official title:

Performance of Pulmonary Embolism Risk Scores for Assessment of Outcome in Computed Tomographic Pulmonary Angiography Confirmed Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05613855
• Other study ID #: performance score outcome
• Status: Not yet recruiting
• Start date: November 2022
• Est. completion date: April 2024

Study information

• Verified date: November 2022
• Source: Assiut University
• Contact: Nourhan Safwat Abdelraheem, resiedent doctor
• Phone: 01067885766
• Email: nourhansafwat22[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients above 18 years old with PE confirmed by CTPA are considered for inclusion in the study.

Exclusion Criteria:

• • 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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

Agnelli 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. Review. — View Citation

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. — View Citation

Elias 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. Review. — View Citation

Jiménez D, Aujesky D, Moores L, Gómez 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. A — View Citation

Kürkciyan 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. — View Citation

Yu 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.2021.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess performance of PERFORM score in predicting outcome in CTPA confirmed patients.		from 11/2022 to 4/2024
Secondary	Compare PERFORM score with the currently validated PESI in risk stratification of patients.		from 11/2022 to 4/2024