SpinChip Hs-cTnI Sample Type Validation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-12

Study Completion Date

2024-07-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

During a heart attack, the protein troponin I is released from the heart muscle into the bloodstream. Measurements of cardiac troponin in blood are used as an aid in the diagnosis of heart attack. The SpinChip hs-cTnI test is a new high-sensitive test for measuring the amount of cardiac troponin I in the bloodstream as an aid in the diagnosis of heart attack.

The purpose of this study is to demonstrate that different types of blood samples (finger prick, venous whole blood and plasma) return comparable results when analysed using the SpinChip hs-cTnI test. Blood samples from at least 150 patients will be analyzed and the testing will be carried out by healthcare personnel.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

SpinChip Hs-cTnI Multisite Precision

NCT06851013

Acute Myocardial Infarction (AMI)

COMPLETED

SpinChip Hs-cTnI Clinical Diagnostic Performance

NCT06499519

Acute Myocardial Infarction

RECRUITING

SpinChip Hs-cTnI Determination of the 99th Percentile URL

NCT06463275

Acute Myocardial Infarction

RECRUITING

Use of Abbott High Sensitivity Troponin I Assay In Acute Coronary Syndromes

NCT02060760

Acute Coronary Syndrome Myocardial Infarction Troponin

COMPLETED

Use of High Sensitivity Cardiac Troponin in Ruling Out Emergency Patients with Acute Myocardial Injury and Infarction

NCT04280926

Acute Myocardial Infarction Acute Coronary Syndrome

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Cardiac troponins are widely used as a biomarker to aid in the diagnosis of Acute myocardial infarction (AMI). These structural proteins are essential in regulating contraction in cardiac muscle cells, and they are sensitive and specific biochemical markers of myocardial damage.

During a heart attack, cardiac muscle cells are injured and release the cardiac marker troponin I (cTnI) into the bloodstream. High-sensitive troponin tests may detect the increase of cardiac troponin in blood within hours after the symptoms of a heart attack has started.

The SpinChip high-sensitivity cardiac troponin I (hs-cTnI) test is a new high-sensitive test for measuring troponin I in blood samples, and the analysis may be performed close to the patient (near-patient test). The results may be obtained within 10 minutes, compared to approximately 1 hour for normal laboratory analysis.

The SpinChip Platform consists of the SpinChip hs-cTnI test and the SpinChip Analyzer and may be used at the emergency department to evaluate patients presenting with symptoms of acute myocardial infarction (chest pain). The test can use blood from finger prick or venous blood samples, either as whole blood or separated into plasma.

The purpose of this study is to demonstrate that different sample types (finger prick, venous whole blood or plasma) give comparable results when analysed using the SpinChip hs-cTnI test when the testing is performed by healthcare professionals. Samples from minimum 150 patients with troponin levels covering the measuring range of the SpinChip hs-cTnI test will be collected and analysed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SpinChip hs-cTnI

SpinChip Platform, consisting of the SpinChip hs-cTnI test (self-contained cartridge) and SpinChip Analyzer (instrument)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Able and willing to provide signed written informed consent
* Subjects \>18 years old
* Clinical cardiac Troponin T concentration available

Exclusion Criteria

* Cognitive impairment precluding informed consent
* Self-reported pregnancy
* General clinical condition which affects the patient in a major way and the patient is considered to be in an unstable clinical condition
* Previously included in the study with a sample within the measuring range of the SpinChip hs-cTnI test

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No