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

NCT07805616 | Recruiting

• 1 other identifier: 09.2026.26-0432
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Embolism; Venous Thromboembolism; Acute Pulmonary Embolism

Keywords

AHA/ACC guidelines; MAPEE; risk stratification

Outcome Measures

Primary Outcomes (1)

• Major Adverse Pulmonary Embolism Event (MAPEE) - 30-day composite

  Composite of: (1) all-cause mortality, OR (2) hemodynamic deterioration (SBP \<90 mmHg for \>=15 minutes or vasopressor requirement), OR (3) treatment escalation (systemic thrombolysis, catheter-directed therapy, surgical embolectomy, or ECMO), OR (4) cardiopulmonary resuscitation - within 30 days of ED presentation.

  30 days

Secondary Outcomes (6)

• S1: AHA/ACC vs ESC 2019 ROC-AUC comparison (exploratory)

  30 days

• S2: NPV of AHA/ACC Category A+B for MAPEE

  30 days

• S3: MAPEE trend across AHA/ACC subcategories C1, C2, C3

  30 days

• S4: Odds ratio for MAPEE by R modifier status

  30 days

• S5: Intensive care unit (ICU) admission rate by AHA/ACC category

  Up to 30 days

Study Arms (1)

Acute PE Cohort - AHA/ACC 2026 Categories A-E + R modifier

All consecutive adult patients presenting to the emergency department with confirmed acute pulmonary embolism, assigned to 2026 AHA/ACC clinical categories (A-E) plus right ventricular strain (R) modifier at presentation. No study intervention is assigned; all patients are treated per standard of care per treating clinician judgment.

Other: 2026 AHA/ACC Clinical Risk Categorization

Interventions

2026 AHA/ACC Clinical Risk Categorization OTHER

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.

Acute PE Cohort - AHA/ACC 2026 Categories A-E + R modifier

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (\>=18 years) presenting to Marmara University Pendik Training and Research Hospital Emergency Department with confirmed acute pulmonary embolism on CTPA between April 2026 and January 2027.

You may qualify if:

• Age \>=18 years
• Confirmed acute PE on CT pulmonary angiography (CTPA) within 24 hours of ED presentation
• Informed consent obtained
• Ability to complete 30-day follow-up

You may not qualify if:

• Chronic thromboembolic pulmonary hypertension (CTEPH)
• Age \<18 years
• Pregnancy
• Incomplete CTPA or non-diagnostic imaging
• Prior PE within 3 months
• Refusal of informed consent
• Inability to complete 30-day follow-up (no phone/address)

Sponsors & Collaborators

• Marmara University Pendik Training and Research Hospital: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, 34899, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism

Study Officials

• Arzu Gundogdu

  Marmara University

  PRINCIPAL INVESTIGATOR

• Mustafa Altun, Emergency Medicine Specialist

  Marmara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emir Ünal, Assistant Professor

CONTACT

+90 216 657 06 06; emirunal@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: September 4, 2026
• Study Start: April 17, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)