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New rapid blood test could speed up heart attack diagnosis

NCT ID NCT06463275

Diagnosis Sponsor: SpinChip Diagnostics ASA 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study measured troponin I levels in 1355 healthy adults to determine normal ranges for a new rapid test called SpinChip hs-cTnI. Troponin is a protein released during a heart attack, and having accurate normal values helps doctors diagnose heart attacks more reliably. The test uses a small cartridge and analyzer to give quick results from a blood sample.

What this could mean

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

Active substance
SpinChip hs-cTnI test (a diagnostic test using a cartridge and analyzer to measure troponin I in blood)
What this could lead to
If successful, this test could help doctors diagnose heart attacks faster and more accurately using a simple blood sample.
What could go wrong
This study only established normal reference ranges in healthy people; it did not test the test's ability to diagnose heart attacks in real patients. Further studies are needed.

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

1,355 people

The number who actually took part.

Started

May 2024

Finished

Sep 2025

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

A minimum of 800 healthy subjects with a balanced gender distribution (minimum 400 females and 400 males).

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Able and willing to provide signed written informed consent * 18-80 years old * Estimated glomerular filtration rate (eGFR) \> 60 mL/min/1.73 m2 for subjects 18-65 years and \> 50 mL/min/1.73 m2 for subjects \> 66 years * Haemoglobin A1c (HbA1c) \< 6.5% (\< 48 mmol/mol) * NT-proBNP (N-terminal prohormone of brain natriuretic peptide) \< 125 ng/L or BNP (brain natriuretic peptide) \< 35 ng/L Exclusion Criteria: * All known cardiovascular or cardiac diseases (evaluated using questionnaire; personal history of acute myocardial infarction (AMI) or other cardiac diseases (angina, stroke, atrial fibrillation, peripheral vascular disease (PVD), deep vein thrombosis (DVT), pulmonary embolism (PE), cardiac valve disease, heart failure) * Treatment for hyperlipidaemia (medication reported in questionnaire) * Hypertension (as judged by the investigator) or use of medication for hypertension (medication reported in questionnaire) * Treatment for diabetes, including dietary treatment (reported in questionnaire) * Abnormal BMI (body mass index) (\< 18 kg/m2 or \> 35 kg/m2), calculated from data collected during enrolment visit * Current smokers (reported in questionnaire) * Major illness or chronic disease that could affect the heart (lung, liver, unstable or nontreated thyroid disease, or autoimmune diseases (evaluated using questionnaire) * History of cancer within the last 5 years (based on questionnaire) except basal cell carcinoma (in situ) * Recent acute hospitalisation (within last 3 months, reported in questionnaire) * Pregnancy (reported in questionnaire) * Already included in the study

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Conditions

The condition(s) this trial relates to.

acute myocardial infarction myocardial infarction

As listed by the trial registrant

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

Acute myocardial infarction

Contacts and locations

Locations

  • CTC Clinical Trial Consultants AB

    Uppsala, Uppsala County, 752 37, Sweden

  • Clinical Trial Consultants (CTC) Ebbepark

    Linköping, 58213, Sweden

  • Clinical Trial Consultants (CTC) GoCo

    Mölndal, Gothenburg, 431 53, Sweden

  • Phase I-IV Research Unit Karolinska

    Solna, 171 64, Sweden

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