RecruitingNCT07805616

Prognostic Value of 2026 AHA/ACC Clinical Categorization in Acute Pulmonary Embolism Patients Presenting to the Emergency Department

Prognostic Value of the 2026 American Heart Association/American College of Cardiology (AHA/ACC) Clinical Categorization System (Categories A-E) for Predicting 30-Day Major Adverse Pulmonary Embolism Events (MAPEE) in Patients Presenting to the Emergency Department With Acute Pulmonary Embolism: A Prospective Observational Cohort Study


Sponsor

Marmara University Pendik Training and Research Hospital

Enrollment

600 participants

Start Date

Apr 17, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

Background: The 2026 American Heart Association/American College of Cardiology (AHA/ACC) Pulmonary Embolism Guideline (Creager et al., Circulation 2026) introduced a novel five-category (A-E) clinical classification system with subcategories and an R modifier, replacing prior risk stratification frameworks. Prospective validation of this classification system using composite clinical outcomes is lacking. Objective: To evaluate the prognostic value of the 2026 AHA/ACC clinical categorization (Categories A-E plus R modifier) for predicting 30-day Major Adverse Pulmonary Embolism Events (MAPEE) in emergency department (ED) patients with acute pulmonary embolism (PE). Methods: Prospective observational cohort study conducted at Marmara University Faculty of Medicine Emergency Department, enrolling 600 consecutive adult patients with confirmed acute PE by computed tomography (CT) pulmonary angiography between April 2026 and January 2027. Primary outcome: MAPEE composite (all-cause mortality OR hemodynamic deterioration OR treatment escalation OR cardiopulmonary resuscitation) within 30 days. Secondary outcomes include area under the receiver operating characteristic curve (AUC) comparison with the European Society of Cardiology (ESC) 2019 risk stratification (exploratory), negative predictive value (NPV) of low-risk categories (A+B) for safe discharge, MAPEE trend across C1/C2/C3, and R modifier odds ratio. Statistical analysis: Jamovi v2.x. Reporting follows the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) 2007 checklist.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying 2026 AHA/ACC Clinical Risk Categorization for people with acute pulmonary embolism, pulmonary embolism, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHER2026 AHA/ACC Clinical Risk Categorization

Not a therapeutic intervention. Refers to the 2026 AHA/ACC clinical categorization framework (Categories A-E plus R modifier for right ventricular strain) applied at presentation to prognostically classify patients with confirmed acute pulmonary embolism. All patients are managed per standard institutional practice; no protocol-driven treatment or diagnostic assignment is made based on this categorization.


Locations(1)

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

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NCT07805616


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