Ignite Creation Date:
2024-07-17 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463275
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-07
Brief Title:
SpinChip Hs-cTnI Determination of the 99th Percentile URL
Sponsor:
SpinChip Diagnostics ASA
Organization:
SpinChip Diagnostics ASA
Study Overview
Official Title:
Determination of the 99th Percentile Upper Reference Limits URLs for the SpinChip High Sensitivity Cardiac Troponin I SpinChip Hs-cTnI Test
Status:
RECRUITING
Status Verified Date:
2024-06
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-3
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 Low levels of troponin are also present in the blood stream of healthy individuals and can be detected by high-sensitive troponin tests 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 determine the upper reference limits URLs for the SpinChip hs-cTnI test in a healthy population
The purpose of this study is to determine the upper reference limits URLs for the SpinChip hs-cTnI test in a healthy population
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
According to the European Society of Cardiology ESC 2023 guideline for acute coronary syndrome ACS in patients presenting without persistent ST-segment elevation an elevated cTn value above the 99th percentile upper reference limit URL indicates myocardial injury and when accompanied by evidence of acute myocardial ischemia the disease is defined as AMI The diagnostic threshold 99th percentile URL for each hs-cTn test method must be specifically established
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 using fresh venous whole blood and plasma samples
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 clinical performance study in healthy subjects to determine the 99th percentile URLs for the SpinChip hs-cTnI test according to recommendations from the International Federation of Clinical Chemistry and Laboratory Medicine IFCC
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
According to the European Society of Cardiology ESC 2023 guideline for acute coronary syndrome ACS in patients presenting without persistent ST-segment elevation an elevated cTn value above the 99th percentile upper reference limit URL indicates myocardial injury and when accompanied by evidence of acute myocardial ischemia the disease is defined as AMI The diagnostic threshold 99th percentile URL for each hs-cTn test method must be specifically established
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 using fresh venous whole blood and plasma samples
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 clinical performance study in healthy subjects to determine the 99th percentile URLs for the SpinChip hs-cTnI test according to recommendations from the International Federation of Clinical Chemistry and Laboratory Medicine IFCC
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-SE-23-12-045358 | OTHER | None | None |