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Can a new Five-Category system predict which pulmonary embolism patients will crash?

NCT ID NCT07805616

Knowledge-focused Sponsor: Marmara University Pendik Training and Research Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 · Last updated Sep 04, 2026

Summary

Researchers are testing whether a new 2026 AHA/ACC classification system, which sorts patients with acute pulmonary embolism into categories A through E, can predict who will have a major adverse event within 30 days. The study will enroll 600 adults diagnosed with pulmonary embolism in the emergency department and follow them for a month. The goal is to see if this new system is better than older methods at identifying high-risk patients who need aggressive treatment and low-risk patients who might go home safely.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
No therapeutic intervention. The study applies the 2026 AHA/ACC clinical categorization system (Categories A-E plus R modifier) to classify patients with acute pulmonary embolism at emergency department presentation.
What this could lead to
If the new categories reliably predict which patients face serious complications within 30 days, doctors could better decide who needs intensive care and who might be safe to discharge early.
What could go wrong
This is an observational study, so it cannot prove cause and effect. The sample size is slightly below what would be needed for full statistical power, and the results may not apply to all hospitals or patient groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

pulmonary embolism venous thromboembolism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute pulmonary embolism Pulmonary embolism Venous thromboembolism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Marmara University Pendik Training and Research Hospital

    RECRUITING

    Istanbul, 34899, Turkey (Türkiye)

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