Prognostic value of the 2026 AHA/ACC PE classification in ED patients with acute PE
Official title: 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
Run by Marmara University Pendik Training and Research Hospital · NCT07805616 · Data updated 2026-11-12
This study tests whether the 2026 AHA/ACC five-category PE classification helps predict 30-day major adverse pulmonary embolism events in adults with acute PE presenting to the ED.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Marmara University Pendik Training and Research Hospital Academic / other |
| Locations | 1 site (Istanbul) |
| Status | Recruiting |
| Started | April 17, 2026 |
| Main results expected | January 2027 |
| Study ends | March 2027 |
| Registry record updated | September 4, 2026 |
| Trial ID | NCT07805616 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with confirmed acute PE by CT pulmonary angiography presenting to the Marmara University Pendik ED and able to complete 30-day follow-up.
✕Probably not a fit
Patients with chronic thromboembolic disease, non-diagnostic imaging, or inability to complete 30-day follow-up may not benefit from the classification.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center prospective observational study will enroll 600 adults with confirmed acute pulmonary embolism from an Istanbul ED. Emergency clinicians will independently assign the 2026 AHA/ACC PE category (A–E) with an R modifier at presentation, and patients will be followed for 30 days to capture the composite outcome MAPEE (mortality, hemodynamic deterioration, or treatment escalation). No treatment will be altered by study participation; management will follow standard of care. The primary aim is to evaluate the prognostic value of the new classification for predicting MAPEE within 30 days. Data will describe the association between category assignment and adverse outcomes to inform risk stratification in acute PE.
Why it matters
Potential benefit: If successful, the classification could improve early risk stratification and guide management decisions for ED patients with acute PE.
How similar studies have gone: Prior risk-stratification tools have shown value in PE, but this exact 2026 AHA/ACC categorization is being prospectively validated in this setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \>=18 years 2. Confirmed acute PE on CT pulmonary angiography (CTPA) within 24 hours of ED presentation 3. Informed consent obtained 4. Ability to complete 30-day follow-up Exclusion Criteria: 1. Chronic thromboembolic pulmonary hypertension (CTEPH) 2. Age \<18 years 3. Pregnancy 4. Incomplete CTPA or non-diagnostic imaging 5. Prior PE within 3 months 6. Refusal of informed consent 7. Inability to complete 30-day follow-up (no phone/address)
Where it's running
-
Marmara University Pendik Training and Research Hospital
Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Arzu Gundogdu — Marmara University
- Study coordinator: Emir Ünal, Assistant Professor
- Email: emirunal@gmail.com
- Phone: +90 216 657 06 06
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.