Clinical trial NCT05613855: Performance of Pulmonary Embolism Risk Scores Out Come in CTPA Confirmed Patients
Official title: Performance of Pulmonary Embolism Risk Scores for Assessment of Outcome in Computed Tomographic Pulmonary Angiography Confirmed Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Embolism
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be on patients wh are above 18 years okd who are daignosed to have pulmonary embolism with CTPA

Brief 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

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)

Eligibility criteria: 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

Primary outcomes:
measure: Assess performance of PERFORM score in predicting outcome in CTPA confirmed patients.
timeFrame: from 11/2022 to 4/2024
Secondary outcomes:
measure: Compare PERFORM score with the currently validated PESI in risk stratification of patients.
timeFrame: from 11/2022 to 4/2024
Other outcomes:
Locations:
Study officials:
References:
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. Arch Intern Med. 1991 May;151(5):933-8.
citation: Kurkciyan 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.
citation: Jimenez 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.
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.
citation: 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. No abstract available.
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.2021.100897. eCollection 2021 Jun.