2-Minute heart scan could transform emergency diagnosis of heart failure
NCT ID NCT07685106
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This trial evaluates a new device called CardioStory that uses fiber-optic sensors to measure heart filling pressure in about two minutes—without needles or catheters. Researchers are enrolling 850 adults who come to the emergency department with recent shortness of breath. The goal is to see if the device can accurately distinguish heart failure from other causes like lung problems, helping doctors make faster, more informed decisions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CardioStory device (non-invasive cardiac assessment device)
- What this could lead to
- If successful, this device could help emergency doctors quickly tell whether shortness of breath is due to heart failure or another cause, without invasive procedures.
- What could go wrong
- The device is still being tested and may not prove accurate enough to replace standard diagnostic methods. Results may vary across different 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
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About 850 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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 presenting to the emergency department with acute or subacute dyspnea without an established diagnosis. This population represents patients requiring urgent evaluation to differentiate between cardiac and non-cardiac causes of dyspnea.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Age ≥ 18 years * Recent onset dyspnea (less than 7 days) * Informed consent obtained Exclusion Criteria: * Age inferior to 18 years, * Severe comorbidity, hemodynamic compromise or immediate need for mechanical ventilation were exclusion criteria. * Dyspnea clearly of traumatic or allergic origin
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Fattouma bourguiba university hospital
RECRUITINGMonastir, Monastir Governorate, 5000, Tunisia
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Sahloul university hospital
RECRUITINGSousse, 4054, Tunisia
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