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Stick-On patch aims to catch dangerous heart decline sooner

NCT ID NCT07825363

Diagnosis Sponsor: NIRSense Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are testing a noninvasive wearable sensor patch that uses near-infrared light to continuously measure tissue oxygen and blood flow in people hospitalized with cardiogenic shock after a heart attack or heart failure. Up to 20 adults in a cardiac intensive care unit wear the patches on their chest and arm for about one to three days while receiving standard care. The study compares the patch's readings with standard heart and blood tests to see if the device works and whether it can detect worsening shock earlier.

What this could mean

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

Active substance
a noninvasive wearable sensor patch that uses near-infrared spectroscopy and photoplethysmography to measure tissue oxygen and blood flow
What this could lead to
If it works, this could give doctors an earlier warning when a heart patient's circulation is getting worse, possibly before standard monitors show it.
What could go wrong
This is a small, early pilot study with 20 patients at one hospital. The sensor may not reliably match standard measurements, and it is not yet used to make treatment decisions.

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 20 people

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

Started

Jun 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

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

Adults admitted to the Cleveland Clinic Florida cardiac intensive care unit with acute myocardial infarction undergoing coronary angiography, or with acutely decompensated heart failure, who are in SCAI shock stage B, C, or D. Participants are recruited from the existing patient population of the recruitment site.

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: * Acutely decompensated symptomatic heart failure (HF) documented by: (a) symptoms of HF requiring current treatment; (b) Society for Cardiovascular Angiography and Interventions (SCAI) stage B, C, or D; and (c) hospital admission with HF as the primary or secondary diagnosis; OR acute myocardial infarction (MI) patient undergoing coronary angiography * Admitted to the intensive care unit and currently in SCAI stage B, C, or D * Age 18 years or older * Weight greater than 40 kg Exclusion Criteria: * Prior known severe allergy to medical-grade adhesive or tape (self-reported) * Currently participating in an investigational drug or device study that would interfere with the conduct or results of this study. Trials requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational. * The investigator believes the participant is not an appropriate candidate for the study

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Conditions

The condition(s) this trial relates to.

acute myocardial infarction cardiogenic shock congestive heart failure Shock, Cardiogenic

As listed by the trial registrant

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

Acute decompensated heart failure Acute myocardial infarction Cardiogenic shock

How to take part

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  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

  • Cleveland Clinic Florida, Weston Hospital

    RECRUITING

    Weston, Florida, 33331, United States

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