Chest PainNCT04153006
Comparison of Fingerstick Versus Venous Sample for Troponin I.
An observational study of Chest Pain and Myocardial Infarction, run by VieCuri Medical Centre at 1 site in Netherlands.
Trial summary
This study is a prospective, observational, cohort study aiming to compare point-of-care high-sensitive troponin I testing from different sample types with central laboratory (CL) HS cTnI plasma samples. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain, Myocardial Infarction, Myocardial Ischemia
- What is being tested?
- POC troponin analysis.
- Type of treatment
- Medical device
- How many people
- 131 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Sep 2019to 13 Apr 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients presented at our cardiology ED are eligible for inclusion if they are 18 years or older and suspected of having an ACS based on history, examination, and ECG.
Who may be able to join
- Patients 18 years or older with chest pain suspected of ACS.
Who cannot join
- ST elevation myocardial infarction and 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 and Method Comparison With Minicare® Point-of-care Device for Cardiac Troponin I Assay at the Emergency Department.
This study is a prospective, observational, cohort study aiming to compare point-of-care high-sensitive troponin I testing from different sample types with central laboratory (CL) HS cTnI plasma samples.
A registry of all included patients and their troponin results (POC, CL and HS cTnT) will be made to compare these testing methods.
Read the detailed description
Point-of-care (POC) troponin testing, defined as laboratory testing near a patient location with rapid availability of results, has attracted much interest in the emergency department setting (ED) and seems feasible. These devices might enable earlier decisions, reduce stay at the ED and improve patient flow. While an elevated troponin in patients with suspected acute coronary syndrome (ACS) confirms diagnosis and initiates adequate treatment, ruling out ACS aids in proper patient dismissal. A next step could be ruling out myocardial infarction by the general practitioner (GP) or fast responder using an on-site POC troponin test. However, drawing venous blood might not be easily available to every GP, especially not during peak hours. The Minicare cTnI is a bedside system which requires capillary blood, venous whole blood or plasma. The results of the troponin will be given within 10 minutes. It is a very sensitive troponin test, the most clinically sensitive available POC for c-Troponin. Currently Minicare prepares for a high sensitive troponin analysis targeting a reliable result within an hour after onset of chest pain. The objective of this study is to determine if high sensitive troponin testing by Minicare (POC HS cTnI) has the same analytical performance as standard high sensitivity troponin I testing in our central hospital laboratory ( CL HS cTnI ARCHITECT immunoassay analyzer, Abbott).
- Conditions
- Chest Pain, Myocardial Infarction, Myocardial Ischemia, Heart Attack
- Being tested
- POC troponin analysis.
- Keywords
- Troponin, Point-of-care, Minicare
- Medical subject headings
- Chest Pain, Myocardial Infarction, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POC troponin analysis.Device
Point-of-care (POC) high sensitive troponin I (HS cTnI) analysis in whole blood, plasma and capillary whole blood with the Minicare® device.
| Study group | Role | What they receive |
|---|---|---|
| Chest pain patients | Patients who are admitted to the cardiac ED because of chest pain for ruling out acute coronary syndrome by troponin analysis are eligible for participation.
Troponin analysis will be performed according to standard protocol (0-1h protocol). From every included patient capillary blood samples and an extra venous blood sample will be drawn to evaluate HS cTnI levels obtained with the POC instrument and central laboratory (CL). Receives: Device: POC troponin analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Method and sample comparison
The primary objective is to compare the analytical performance (method and sample comparison) of Minicare® high sensitive troponin I testing (POC, different sample types) and conventional venipuncture troponin I test in our central hospital laboratory (CL) with the Abbott Architect.
This comparison will comprise:
- Minicare® POC (different sample types) vs conventional HS cTnI CL test (Method comparison)
- Minicare® capillary vs. Minicare® venipuncture and vs. Minicare® plasma (Sample comparison)
The analyses linked to the primary objectives are:
- The agreement between POC (three sample types) and CL testing by using the Bland-Altman method.
- The agreement between different POC sample types by using the Bland-Altman method.
The primary objective will be achieved by taking capillary and (an extra) venous blood samples (one per timepoint) from every patient presenting at the cardiac ED with chest pain suspected for ACS.
Measured: 30 days
Secondary outcomes (6)
Major adverse cardiac event (MACE)
MACE is is defined as a composite of cardiac death and myocardial infarction.
Measured: 30 days
Final patients diagnoses.
To compare final patients diagnosis (ACS vs. no ACS) and treatment based on POC venous troponin testing versus CL plasma troponin I testing versus HS cTnT plasma testing (regular patient care).
Measured: 30 days
Overview baseline characteristics.
To create an overview of baseline characteristics of the population.
Measured: 30 days
Linear regression and Pearson's correlation.
- The relationship between POC (three sample types) and CL by linear regression and Pearson's correlation.
- The relationship between POC sample types by linear regression and Pearson's correlation.
Measured: 30 days
Fals-positive and fals-negatives.
To compare the proportion of false positive and false negative results between the different POC samples and if there is a significant difference.
Measured: 30 days
Safety analysis of POC troponin.
To create an overview of the sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of POC and standard laboratory troponin I testing.
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 posted6 Nov 2019
- Study start3 Sep 2019
- Primary completion13 Mar 2020
- Study completion13 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies 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
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- VieCuri Medical Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Healthcare Diagnostics Inc, Minicare® B.V.
- Responsible party
- Principal investigator, Braim Rahel, VieCuri Medical Centre
- Investigators
- Braim Rahel, Dr., Principal investigator, Viecuri MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153006
- Sponsor's protocol ID
- Study number 478
- Other IDs
- NL70186.096.19
- Status last verified
- Jun 2022
- First submitted
- 1 Nov 2019
- 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 and Method Comparison With Minicare® Point-of-care Device for Cardiac Troponin I Assay at the Emergency Department.
- ClinicalTrials.gov ID
- NCT04153006
- Acronym / sponsor ID
- Study number 478
- Conditions
- Chest Pain, Myocardial Infarction, Myocardial Ischemia, Heart Attack
- Keywords
- Troponin, Point-of-care, Minicare
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- VieCuri Medical CentreUniversity, hospital or other
- Collaborators
- Siemens Healthcare Diagnostics Inc, Minicare® B.V.
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Apr 2020 (actual)
- First posted
- 6 Nov 2019 (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, observational, cohort study aiming to compare point-of-care high-sensitive troponin I testing from different sample types with central laboratory (CL) HS cTnI plasma samples.
A registry of all included patients and their troponin results (POC, CL and HS cTnT) will be made to compare these testing methods.
Detailed description
Point-of-care (POC) troponin testing, defined as laboratory testing near a patient location with rapid availability of results, has attracted much interest in the emergency department setting (ED) and seems feasible. These devices might enable earlier decisions, reduce stay at the ED and improve patient flow. While an elevated troponin in patients with suspected acute coronary syndrome (ACS) confirms diagnosis and initiates adequate treatment, ruling out ACS aids in proper patient dismissal. A next step could be ruling out myocardial infarction by the general practitioner (GP) or fast responder using an on-site POC troponin test. However, drawing venous blood might not be easily available to every GP, especially not during peak hours. The Minicare cTnI is a bedside system which requires capillary blood, venous whole blood or plasma. The results of the troponin will be given within 10 minutes. It is a very sensitive troponin test, the most clinically sensitive available POC for c-Troponin. Currently Minicare prepares for a high sensitive troponin analysis targeting a reliable result within an hour after onset of chest pain. The objective of this study is to determine if high sensitive troponin testing by Minicare (POC HS cTnI) has the same analytical performance as standard high sensitivity troponin I testing in our central hospital laboratory ( CL HS cTnI ARCHITECT immunoassay analyzer, Abbott).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chest pain patients | – | Device: POC troponin analysis.Patients who are admitted to the cardiac ED because of chest pain for ruling out acute coronary syndrome by troponin analysis are eligible for participation. Troponin analysis will be performed according to standard protocol (0-1h protocol). From every included patient capillary blood samples and an extra venous blood sample will be drawn to evaluate HS cTnI levels obtained with the POC instrument and central laboratory (CL). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presented at our cardiology ED are eligible for inclusion if they are 18 years or older and suspected of having an ACS based on history, examination, and ECG.
Key inclusion criteria (1 listed)
- Patients 18 years or older with chest pain suspected of ACS.
Key exclusion criteria (5 listed)
- ST elevation myocardial infarction and 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 |
|---|---|---|
| POC troponin analysis.Point-of-care (POC) high sensitive troponin I (HS cTnI) analysis in whole blood, plasma and capillary whole blood with the Minicare® device. | Device | Chest pain patients |
Primary outcome
Method and sample comparison
Time frame: 30 days
The primary objective is to compare the analytical performance (method and sample comparison) of Minicare® high sensitive troponin I testing (POC, different sample types) and conventional venipuncture troponin I test in our central hospital laboratory (CL) with the Abbott Architect. This comparison will comprise: * Minicare® POC (different sample types) vs conventional HS cTnI CL test (Method comparison) * Minicare® capillary vs. Minicare® venipuncture and vs. Minicare® plasma (Sample comparison) The analyses linked to the primary objectives are: * The agreement between POC (three sample types) and CL testing by using the Bland-Altman method. * The agreement between different POC sample types by using the Bland-Altman method. The primary objective will be achieved by taking capillary and (an extra) venous blood samples (one per timepoint) from every patient presenting at the cardiac ED with chest pain suspected for ACS.
6 secondary outcomes
Major adverse cardiac event (MACE)
Time frame: 30 days
Final patients diagnoses.
Time frame: 30 days
Overview baseline characteristics.
Time frame: 30 days
Linear regression and Pearson's correlation.
Time frame: 30 days
Fals-positive and fals-negatives.
Time frame: 30 days
Safety analysis of POC troponin.
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 MC
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 Chest Pain and Myocardial Infarction, 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 1 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?
Method and 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.