Acute Coronary SyndromeWESTCOR-POCNCT05354804
Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain Using Point of Care Assays
A study testing Troponin I (Siemens VTli) 0/1 hour algorithm and Troponin T (Roche Diagnostics) 0/1 hour ESC algorithm in people with Acute Coronary Syndrome, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The aim of the current study is to perform a RCT comparing safety and efficiency of a standard care (in-line with current ESC recommendations) to an algorithm that utilize a POC troponin tests for bedside measurement, the instruments could be located in the ED and return results in few minutes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Troponin I (Siemens VTli) 0/1 hour algorithm and Troponin T (Roche Diagnostics) 0/1 hour ESC algorithm
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,496 participants
- Where
- 1 siteNorway
- Study dates
- 14 Mar 2022to 26 Mar 2024
- Phase
- Interventional
- 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
Who may be able to join
- Patients > 17 years who are referred to the Emergency Department of Haukeland University Hospital with chest pain suspect of ACS
Who cannot join
- STEMI (ECG criteria)
- Patients without STEMI who are immediately transferred to cardiac catheterisation lab (due to heart failure, arrhythmia etc.) without possibility for blood sampling
- Patients admitted from Nursing homes
- Patients transferred from other hospitals (e.g. for PCI treatment)
- Less than 2 months life expectancy from comorbid clinical conditions
- Not possible to provide informed consent due to cognitive impairment, language problems or other reasons
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the current study is to perform a RCT comparing safety and efficiency of a standard care (in-line with current ESC recommendations) to an algorithm that utilize a POC troponin tests for bedside measurement, the instruments could be located in the ED and return results in few minutes.
Read the detailed description
Ischemic coronary artery disease is an important health challenge and a common cause of death worldwide. Patients with symptoms suggestive of acute coronary syndrome are frequently referred to the emergency department (ED) and impose a high work-load on hospitals. Since 2009, high-sensitivity cardiac troponin (hs-cTn) assays have become a crucial ED tool for differentiating between patients with and without Non-ST-elevation myocardial infarction (NSTEMI). Accordingly, the European Society of Cardiology (ESC) recommends 0-1 hour algorithms that use hs-cTn for rule-out and rule-in of NSTEMI.
Additionally, the clinical suspicion of acute coronary syndrome (ACS) or other life-threating conditions must be low.
Unfortunately, these algorithms have been difficult to implement into routine and clinical practice, and are only used by a limited number of hospitals due to lack of randomized clinical trials and practical obstacles, including turnaround time for troponins.
The aim of the current study is to perform a RCT comparing safety and efficiency of a standard care (in-line with current ESC recommendations) to an algorithm that utilize a POC troponin tests for bedside measurement, the instruments could be located in the ED and return results in few minutes.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Troponin I (Siemens VTli) 0/1 hour algorithm, Troponin T (Roche Diagnostics) 0/1 hour ESC algorithm
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Troponin I (Siemens VTli) 0/1 hour algorithmDiagnostic test
Patients will be investigated using the ESC 0/1 hour cTnT algorithm from ESC compared to a 0/1 hour algorithm utilizing the Siemens VTli POC instrument for cTnI.
Troponin T (Roche Diagnostics) 0/1 hour ESC algorithmDiagnostic test
Patients will be investigated using the ESC 0/1 hour cTnT algorithm from ESC compared to a 0/1 hour algorithm utilizing the Siemens VTli POC instrument for cTnI.
| Study group | Role | What they receive |
|---|---|---|
| Standard | Placebo comparator | Patients randomized to standard care will be sampled at admission and after 1 hour (and furthermore as clinically indicated). High sensitive Troponin T (cTnT) and standard laboratory tests will be measured in the central hospital laboratory using Cobas e801 from Roche Diagnostics and eligibility for rule-out will be judged in accordance with the ESC 0/1 hour rule-out algorithm for cTnT. ECG and HEART-score will be obtained in all patients, other clinical investigations will be ordered by the attending physician. If NSTE-ACS is low risk based on the cTnT algorithm, HEART< 4 and non-ischemic ECG, patients will be investigated according to the ED flow chart for non-coronary acute chest pain, in order to identify differential diagnoses. Patients will be admitted or discharged based on the clinical judgement of the attending physician. Receives: Diagnostic Test: Troponin T (Roche Diagnostics) 0/1 hour ESC algorithm |
| POC | Active comparator | Blood samples will be obtained at admission, standard blood tests will be measured at the central laboratory whilst high sensitive troponin I at 0 and 1 hour will be analyzed using a POC instrument from Siemens Healthineers in the ED. ECG and HEART-score will be obtained in all patients, other clinical investigations will be ordered by the attending physician. If the cTnI concentration at admission and the 1-hour delta is below a pre-specified concentration, the HEART- score < 4, and the ECG is non-ischemic the patients will be allocated to the rule-out of NSTEMI group and investigated according to the ED flow chart for non-coronary acute chest pain, in order to identify differential diagnosis. Finally, patients will be admitted or discharged based on the clinical judgement of the attending physician. Receives: Diagnostic Test: Troponin I (Siemens VTli) 0/1 hour algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay in the Emergency Department (ED)
Difference in length of stay in the ED will be compared between the two arms
Measured: Up to 24 hours
Secondary outcomes (12)
Discharge rate at 3 hours
Percentages of patients who are discharged within 3 hours will be compared between the two arms
Measured: 3 hours
Discharge rate at 6 hours
Percentages of patients who are discharged within 6 hours will be compared between the two arms
Measured: 6 hours
Total length of stay
Time from arrival in the ED to discharge from hospital (hours) will be compared between the two arms
Measured: Up to 3 months
Composite of myocardial infarction and death
Differences in composite of death, myocardial infarction and acute revascularization within 30 days will be compared between the two arms.
Measured: 30 days
Composite of myocardial infarction, death and revascularization
Death, myocardial infarction or acute revascularization within 12 months after inclusion will be compared between the two arms
Measured: 30 days
Composite of myocardial infarction and death
Differences in composite of death, myocardial infarction and acute revascularization within 30 days will be compared between the two arms.
Measured: 1 year
Composite of myocardial infarction, death and revascularization
Death, myocardial infarction or acute revascularization within 12 months after inclusion will be compared between the two arms
Measured: 1 year
Total patient episode costs
Total patient episode costs will be calculated and compared between the two arms
Measured: Up to 3 months
12 months costs
Costs related to all hospital contacts during 12 months follow-up
Measured: 12 months
Patients quality of life according to RAND-12
Patients quality of life will be measured 30 days after discharge using RAND-12 questionnaire and compared between the two arms.
Measured: 30 days
Symptom burden
Patients quality of life will be measured 30 days after discharge using SAQ7 questionnaire and compared between the two arms
Measured: 30 days
Patient satisfaction
Change in patients satisfaction with the hospital admission/contact will be measured 30 days after discharge using PasOP14 questionnaire and compared between the two arms
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 posted29 Apr 2022
- Study start14 Mar 2022
- Primary completion26 Mar 2024
- Study completion26 Mar 2024
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.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,496 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology
- Responsible party
- Sponsor
- Investigators
- Kristin M Aakre, MD/PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354804
- Sponsor's protocol ID
- 285544
- Acronym
- WESTCOR-POC
- Status last verified
- Aug 2023
- First submitted
- 22 Mar 2022
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain Using Point of Care Assays
- ClinicalTrials.gov ID
- NCT05354804
- Acronym / sponsor ID
- WESTCOR-POC / 285544
- Conditions
- Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,496 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 26 Mar 2024 (actual)
- First posted
- 29 Apr 2022 (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.
The aim of the current study is to perform a RCT comparing safety and efficiency of a standard care (in-line with current ESC recommendations) to an algorithm that utilize a POC troponin tests for bedside measurement, the instruments could be located in the ED and return results in few minutes.
Detailed description
Ischemic coronary artery disease is an important health challenge and a common cause of death worldwide. Patients with symptoms suggestive of acute coronary syndrome are frequently referred to the emergency department (ED) and impose a high work-load on hospitals. Since 2009, high-sensitivity cardiac troponin (hs-cTn) assays have become a crucial ED tool for differentiating between patients with and without Non-ST-elevation myocardial infarction (NSTEMI). Accordingly, the European Society of Cardiology (ESC) recommends 0-1 hour algorithms that use hs-cTn for rule-out and rule-in of NSTEMI.
Additionally, the clinical suspicion of acute coronary syndrome (ACS) or other life-threating conditions must be low.
Unfortunately, these algorithms have been difficult to implement into routine and clinical practice, and are only used by a limited number of hospitals due to lack of randomized clinical trials and practical obstacles, including turnaround time for troponins.
The aim of the current study is to perform a RCT comparing safety and efficiency of a standard care (in-line with current ESC recommendations) to an algorithm that utilize a POC troponin tests for bedside measurement, the instruments could be located in the ED and return results in few minutes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Placebo comparator | Diagnostic Test: Troponin T (Roche Diagnostics) 0/1 hour ESC algorithmPatients randomized to standard care will be sampled at admission and after 1 hour (and furthermore as clinically indicated). High sensitive Troponin T (cTnT) and standard laboratory tests will be measured in the central hospital laboratory using Cobas e801 from Roche Diagnostics and eligibility for rule-out will be judged in accordance with the ESC 0/1 hour rule-out algorithm for cTnT. ECG and HEART-score will be obtained in all patients, other clinical investigations will be ordered by the attending physician. If NSTE-ACS is low risk based on the cTnT algorithm, HEART< 4 and non-ischemic ECG, patients will be investigated according to the ED flow chart for non-coronary acute chest pain, in order to identify differential diagnoses. Patients will be admitted or discharged based on the clinical judgement of the attending physician. |
| POC | Active comparator | Diagnostic Test: Troponin I (Siemens VTli) 0/1 hour algorithmBlood samples will be obtained at admission, standard blood tests will be measured at the central laboratory whilst high sensitive troponin I at 0 and 1 hour will be analyzed using a POC instrument from Siemens Healthineers in the ED. ECG and HEART-score will be obtained in all patients, other clinical investigations will be ordered by the attending physician. If the cTnI concentration at admission and the 1-hour delta is below a pre-specified concentration, the HEART- score < 4, and the ECG is non-ischemic the patients will be allocated to the rule-out of NSTEMI group and investigated according to the ED flow chart for non-coronary acute chest pain, in order to identify differential diagnosis. Finally, patients will be admitted or discharged based on the clinical judgement of the attending physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients > 17 years who are referred to the Emergency Department of Haukeland University Hospital with chest pain suspect of ACS
Key exclusion criteria (6 listed)
- STEMI (ECG criteria)
- Patients without STEMI who are immediately transferred to cardiac catheterisation lab (due to heart failure, arrhythmia etc.) without possibility for blood sampling
- Patients admitted from Nursing homes
- Patients transferred from other hospitals (e.g. for PCI treatment)
- Less than 2 months life expectancy from comorbid clinical conditions
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 |
|---|---|---|
| Troponin I (Siemens VTli) 0/1 hour algorithmPatients will be investigated using the ESC 0/1 hour cTnT algorithm from ESC compared to a 0/1 hour algorithm utilizing the Siemens VTli POC instrument for cTnI. | Diagnostic test | POC |
| Troponin T (Roche Diagnostics) 0/1 hour ESC algorithmPatients will be investigated using the ESC 0/1 hour cTnT algorithm from ESC compared to a 0/1 hour algorithm utilizing the Siemens VTli POC instrument for cTnI. | Diagnostic test | Standard |
Primary outcome
Length of stay in the Emergency Department (ED)
Time frame: Up to 24 hours
Difference in length of stay in the ED will be compared between the two arms
12 secondary outcomes
Discharge rate at 3 hours
Time frame: 3 hours
Discharge rate at 6 hours
Time frame: 6 hours
Total length of stay
Time frame: Up to 3 months
Composite of myocardial infarction and death
Time frame: 30 days
Composite of myocardial infarction, death and revascularization
Time frame: 30 days
Composite of myocardial infarction and death
Time frame: 1 year
Composite of myocardial infarction, death and revascularization
Time frame: 1 year
Total patient episode costs
Time frame: Up to 3 months
12 months costs
Time frame: 12 months
Patients quality of life according to RAND-12
Time frame: 30 days
Symptom burden
Time frame: 30 days
Patient satisfaction
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 19 Jul 2024.
- Individual participant dataSharing planned: No. We do not plan to share individual participant data.
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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.
Kristin M Aakre, MD/PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Troponin I (Siemens VTli) 0/1 hour algorithm and Troponin T (Roche Diagnostics) 0/1 hour ESC algorithm in people with Acute Coronary Syndrome, run by Haukeland University Hospital at 1 site in Norway.
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 6 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 19 Jul 2024. 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 Norway. 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. Some participants in this study may receive a placebo. 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?
Length of stay in the Emergency Department (ED) (time frame: Up to 24 hours). 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 19 Jul 2024.