Acute Coronary SyndromeNCT04458155
Li-Hep vs. Non-Li-Hep Coated Transfer Device
An observational study of Acute Coronary Syndrome and Chest Pain, run by VieCuri Medical Centre at 1 site in Netherlands.
Trial summary
This study is a prospective, diagnostic, cohort study within the standard care of acute coronary syndrome (ACS) patients. It compares the analytical performance of Siemens® point-of-care high sensitive troponin I testing in venous, plasma and capillary sample types. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Chest Pain, Myocardial Infarction
- What is being tested?
- Siemens® Point-of-care high sensitive troponin I analyzer
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Jun 2020to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All patients presented at our cardiology ED or coronary care unit (CCU) are eligible for inclusion if they are 18 years or older and suspected of having an ACS based on history, examination, ECG and regular troponin results from the central laboratory.
Who may be able to join
- Age 18 years or older.
- Referred to cardiac ED with chest pain suspected of ACS; inclusion at arrival (T=0) or one hour after arrival (T=1).
- Subacute STEMI or NSTEMI patients admitted at the CCU who have an indication for coronary angiography but do not need rescue/emergency PCI.
- STEMI patients who already underwent rescue/emergency PCI; inclusion post PCI.
Who cannot join
- Out of hospital cardiac arrest.
- Patients with sudden onset tachycardia and a frequency of 110 bpm or higher (supraventricular or ventricular).
- Patients who are hemodynamically unstable or in which an acute non-coronary diagnosis is suspected, e.g. pulmonary embolism, thoracic aortic dissection etc.
- Patients recently already admitted for the same set of symptoms at a previous healthcare institution before being transferred to the participating clinical site.
- Patients not willing or not able to provide informed consent due to their medical condition as judged by the physician.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sample Comparison With Siemens® Point-of-care Device for Cardiac Troponin I Assay by Using a Heparin Coated Transfer Device vs. Non-heparin Coated Transfer Device at the Emergency Department (Validation Study 2.0)
This study is a prospective, diagnostic, cohort study within the standard care of acute coronary syndrome (ACS) patients. It compares the analytical performance of Siemens® point-of-care high sensitive troponin I testing in venous, plasma and capillary sample types. The investigators hypothesize that there is a good correlation between the Siemens® POC HS cTnI assay results for the three sample types and that the bias between different POC sample types reduces from ~10% to ≤ 5% when using heparinized transfer device for the capillary sample.
Read the detailed description
In September 2019, the validation study 1.0 started, in which the cTnI result of the Siemens POC device on three sample types are compared. Interim analysis of the sample comparison was performed by regression analysis using Passing and Bablock, and calculating the Pearson correlation coefficient.
The Li-hep Plasma vs Li-hep venous blood show a very good correlation of 1.00-1.03 with an R of >0.99, so the results between these sample types can be used interchangeably. For the capillary sample vs the Li-hep sample (both blood and plasma) the slope is 8-12% higher. With a 8-12% higher response, the capillary test results may not be interchangeably used with the other 2 sample types.
It is remarkable that capillary samples give a higher response, since it was anticipated that the result may be slightly lower due to the possible dilution by interstitial fluid. The investigators hypothesize that the presence of the Li-heparin anti-coagulant in the venous draw lead to a slight reduction of the apparent cTnI concentration. By using a heparin coated transfer device for the capillary samples instead of an uncoated transfer device, this hypothesis will be tested.
- Being tested
- Siemens® Point-of-care high sensitive troponin I analyzer
- Keywords
- Troponin, Point-of-care, Acute coronary syndrome, Siemens, Chest pain
- Medical subject headings
- Acute Coronary Syndrome, Chest Pain, Myocardial Infarction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Siemens® Point-of-care high sensitive troponin I analyzerDevice
Point-of-care (POC) high sensitive troponin I (HS cTnI) analysis in whole blood, plasma and capillary whole blood with the Siemens® device.
| Study group | Role | What they receive |
|---|---|---|
| Chest pain patients | Patients are eligible for participation if they are admitted to:
* The cardiac emergency department (ED) because of chest pain for ruling out acute coronary syndrome by troponin analysis
* The Coronary Care Unit (CCU) with a NSTEMI or post-percutaneous coronary intervention (PCI) STEMI.
Troponin analysis will be performed according to standard protocol. From every included patient two capillary blood samples and an extra venous blood sample will be drawn during regularly ordered blood work to evaluate HS cTnI levels obtained with the POC instrument. Receives: Device: Siemens® Point-of-care high sensitive troponin I analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sample comparison
The primary objective is to compare the analytical performance of Siemens® point-of-care high sensitive troponin I testing in different sample types by using the coefficient of variation.
This comparison will comprise Siemens® POC capillary vs. Siemens® POC venipuncture and vs. Siemens® POC plasma (Sample comparison).
The primary objective will be achieved by taking:
- Two capillary samples > one sample with a heparin coated transfer device (drawn from a finger of the right hand) and the other one with a non-heparin coated transfer device. (drawn from a finger of the left hand)
- One extra venous blood sample > for POC venous and POC plasma analysis.
Trained clinical staff will collect the different samples. All samples will be collected once, at one time point with a maximum of 10 minutes in between.
Measured: 30 days
Secondary outcomes (6)
Bland-Altman method
To compare the analytical performance of Siemens® point-of-care high sensitive troponin I testing in different sample types by using the Bland-Altman method.
Measured: 30 days
Linear regression and Pearson's correlation.
The relationship between POC sample types by linear regression and Pearson's correlation.
Measured: 30 days
Overview baseline characteristics.
To create an overview of baseline characteristics of the population.
Measured: 30 days
Major adverse cardiac event (MACE)
MACE is is defined as a composite of cardiac death and myocardial infarction.
Measured: 30 days
Modified HEART score
To determine the modified HEART score retrospectively based upon POC capillary results in the population.
Measured: 30 days
Modified HEART score comparison
To compare the retrospectively determined modified HEART score based upon POC capillary heparin coated transfer device with the retrospectively determined modified HEART score based upon POC capillary non-heparin coated transfer device.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start18 Jun 2020
- Primary completion19 Dec 2020
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- VieCuri Medical Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology
- Responsible party
- Principal investigator, Braim Rahel, VieCuri Medical Centre
- Investigators
- Braim Rahel, Dr., Principal investigator, VieCuri Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458155
- Sponsor's protocol ID
- Study number 580
- Other IDs
- METCZ20200008, NL72445.096.20
- Status last verified
- Jun 2022
- First submitted
- 30 Jun 2020
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sample Comparison With Siemens® Point-of-care Device for Cardiac Troponin I Assay by Using a Heparin Coated Transfer Device vs. Non-heparin Coated Transfer Device at the Emergency Department (Validation Study 2.0)
- ClinicalTrials.gov ID
- NCT04458155
- Acronym / sponsor ID
- Study number 580
- Keywords
- Troponin, Point-of-care, Acute coronary syndrome, Siemens, Chest pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- VieCuri Medical CentreUniversity, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 19 Dec 2020 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, diagnostic, cohort study within the standard care of acute coronary syndrome (ACS) patients. It compares the analytical performance of Siemens® point-of-care high sensitive troponin I testing in venous, plasma and capillary sample types. The investigators hypothesize that there is a good correlation between the Siemens® POC HS cTnI assay results for the three sample types and that the bias between different POC sample types reduces from ~10% to ≤ 5% when using heparinized transfer device for the capillary sample.
Detailed description
In September 2019, the validation study 1.0 started, in which the cTnI result of the Siemens POC device on three sample types are compared. Interim analysis of the sample comparison was performed by regression analysis using Passing and Bablock, and calculating the Pearson correlation coefficient.
The Li-hep Plasma vs Li-hep venous blood show a very good correlation of 1.00-1.03 with an R of >0.99, so the results between these sample types can be used interchangeably. For the capillary sample vs the Li-hep sample (both blood and plasma) the slope is 8-12% higher. With a 8-12% higher response, the capillary test results may not be interchangeably used with the other 2 sample types.
It is remarkable that capillary samples give a higher response, since it was anticipated that the result may be slightly lower due to the possible dilution by interstitial fluid. The investigators hypothesize that the presence of the Li-heparin anti-coagulant in the venous draw lead to a slight reduction of the apparent cTnI concentration. By using a heparin coated transfer device for the capillary samples instead of an uncoated transfer device, this hypothesis will be tested.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chest pain patients | – | Device: Siemens® Point-of-care high sensitive troponin I analyzerPatients are eligible for participation if they are admitted to: * The cardiac emergency department (ED) because of chest pain for ruling out acute coronary syndrome by troponin analysis * The Coronary Care Unit (CCU) with a NSTEMI or post-percutaneous coronary intervention (PCI) STEMI. Troponin analysis will be performed according to standard protocol. From every included patient two capillary blood samples and an extra venous blood sample will be drawn during regularly ordered blood work to evaluate HS cTnI levels obtained with the POC instrument. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients presented at our cardiology ED or coronary care unit (CCU) are eligible for inclusion if they are 18 years or older and suspected of having an ACS based on history, examination, ECG and regular troponin results from the central laboratory.
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Referred to cardiac ED with chest pain suspected of ACS; inclusion at arrival (T=0) or one hour after arrival (T=1).
- Subacute STEMI or NSTEMI patients admitted at the CCU who have an indication for coronary angiography but do not need rescue/emergency PCI.
- STEMI patients who already underwent rescue/emergency PCI; inclusion post PCI.
Key exclusion criteria (5 listed)
- Out of hospital cardiac arrest.
- Patients with sudden onset tachycardia and a frequency of 110 bpm or higher (supraventricular or ventricular).
- Patients who are hemodynamically unstable or in which an acute non-coronary diagnosis is suspected, e.g. pulmonary embolism, thoracic aortic dissection etc.
- Patients recently already admitted for the same set of symptoms at a previous healthcare institution before being transferred to the participating clinical site.
- Patients not willing or not able to provide informed consent due to their medical condition as judged by the physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Siemens® Point-of-care high sensitive troponin I analyzerPoint-of-care (POC) high sensitive troponin I (HS cTnI) analysis in whole blood, plasma and capillary whole blood with the Siemens® device. | Device | Chest pain patients |
Primary outcome
Sample comparison
Time frame: 30 days
The primary objective is to compare the analytical performance of Siemens® point-of-care high sensitive troponin I testing in different sample types by using the coefficient of variation. This comparison will comprise Siemens® POC capillary vs. Siemens® POC venipuncture and vs. Siemens® POC plasma (Sample comparison). The primary objective will be achieved by taking: * Two capillary samples > one sample with a heparin coated transfer device (drawn from a finger of the right hand) and the other one with a non-heparin coated transfer device. (drawn from a finger of the left hand) * One extra venous blood sample > for POC venous and POC plasma analysis. Trained clinical staff will collect the different samples. All samples will be collected once, at one time point with a maximum of 10 minutes in between.
6 secondary outcomes
Bland-Altman method
Time frame: 30 days
Linear regression and Pearson's correlation.
Time frame: 30 days
Overview baseline characteristics.
Time frame: 30 days
Major adverse cardiac event (MACE)
Time frame: 30 days
Modified HEART score
Time frame: 30 days
Modified HEART score comparison
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Braim Rahel, Dr. principal investigator
VieCuri Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Chest Pain, run by VieCuri Medical Centre at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sample comparison (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.