Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453707
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2024-05-29
Brief Title:
SpinChip Hs-cTnI Sample Type Validation
Sponsor:
SpinChip Diagnostics ASA
Organization:
SpinChip Diagnostics ASA
Study Overview
Official Title:
Sample Type Validation Finger Prick and Plasma vs Whole Blood in a Clinical Setting for the SpinChip High-sensitivity Cardiac Troponin I SpinChip Hs-cTnI Test
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEAT-2
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIV-NO-24-01-045754 | OTHER | EUDAMED | None |