Ignite Creation Date:
2024-07-17 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499519
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-05
Brief Title:
SpinChip Hs-cTnI Clinical Diagnostic Performance
Sponsor:
SpinChip Diagnostics ASA
Organization:
SpinChip Diagnostics ASA
Study Overview
Official Title:
Clinical Diagnostic Performance of the SpinChip High-sensitivity Cardiac Troponin I SpinChip Hs-cTnI Test
Status:
RECRUITING
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-4
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 evaluate the diagnostic accuracy and safety of the SpinChip hs-cTnI test relative to a clinically validated hs-cTnI method
The purpose of this study is to evaluate the diagnostic accuracy and safety of the SpinChip hs-cTnI test relative to a clinically validated hs-cTnI method
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
This study is a multicentre prospective observational non-randomised open clinical performance study for evaluation of the diagnostic accuracy and safety of the SpinChip hs-cTnI test as an aid in the diagnosis of AMI Subjects presenting with acute chest discomfort or other symptoms suggestive of AMI will be recruited at the emergency departments EDs
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
This study is a multicentre prospective observational non-randomised open clinical performance study for evaluation of the diagnostic accuracy and safety of the SpinChip hs-cTnI test as an aid in the diagnosis of AMI Subjects presenting with acute chest discomfort or other symptoms suggestive of AMI will be recruited at the emergency departments EDs
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-23-12-045095 | OTHER | None | None |