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A sharper eye on the heart: new blood test aims to spot heart attacks faster

NCT ID NCT05853042

Diagnosis Sponsor: Fred Apple Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This trial evaluates a new high-sensitivity blood test (Mindray hs-cTnI) for diagnosing heart attacks in people arriving at the emergency room with symptoms like chest pain. Researchers will compare the test's accuracy against an existing approved test, using blood samples taken at arrival and two hours later. The goal is to see if the new test can reliably rule out or confirm a heart attack, potentially speeding up care.

What this could mean

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

Active substance
high-sensitivity cardiac troponin I blood test (Mindray hs-cTnI assay)
What this could lead to
If successful, this could provide a faster, more accurate way to diagnose heart attacks in the emergency room, potentially reducing unnecessary hospital stays.
What could go wrong
This is a diagnostic accuracy study, not a treatment trial. The test may not prove more effective than existing assays, and results may vary across different patient populations.

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

1,559 people

The number who actually took part.

Started

Dec 2022

Finished

Jul 2025

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

Consecutive patients (goal, 1500 patients over 4 months) presenting to the emergency department, in whom serial cTnI measurements are ordered on clinical indication at Hennepin Healthcare / Hennepin County Medical Center (Minneapolis, MN, USA) to rule-in and rule-out acute myocardial infarction.

Ages

21 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. Presents to the ED, or ambulatory care center equivalent, with signs or symptoms suspicious of a possible ACS/ischemic event. 2. Baseline cTn-I measurement and one additional cTn-I measurement at two hours after the first measurement. 3. At least one 12-lead electrocardiogram Exclusion Criteria: 1. Less than 21 years old 2. Pregnancy 3. Trauma 4. Declines to participate or has indicated that their blood/ medical information cannot be used for investigational purposes 5. Did not present through the ED 6. Transferred from an outside hospital or clinic 7. Has already been enrolled in the study

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome acute myocardial infarction dilated cardiomyopathy 1FF

As listed by the trial registrant

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

Acute coronary syndrome Acute myocardial infarction

Contacts and locations

Locations

  • Hennepin Healthcare Research Institute / Hennepin County Medical Center

    Minneapolis, Minnesota, 55404, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.