Acute Coronary SyndromeWESTCORNCT02620202
Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain
An observational study of Acute Coronary Syndrome, run by Haukeland University Hospital at 2 sites in Norway.
Trial summary
The main aim of the WESTCOR study is to investigate the ability of two high sensitive cardiac troponin (hs-cTn) assays to diagnose acute coronary syndrome and predict prognosis in different patient populations (e.g. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 1,900 participants
- Where
- 2 sitesNorway
- Study dates
- Sep 2015to May 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: Patients admitted to the Emergency Department at Haukeland University Hospital or Stavanger University Hospital with symptoms indicative of acute coronary syndrome
Who may be able to join
- Patients admitted to the Emergency Department with a clinical suspicion of acute coronary syndrome i.e. chest pain or pain radiating down the arms, the back, into the jaw, throat or into the lower teeth. Chest pain must not be the most dominant symptom but may or may not be combined with e.g. dyspnea, nausea, anxiousness or palpitations.
- Age >= 18 years
Who cannot join
- ST elevation MI
- Age < 18 years
- Patients not able to give informed consent
- Patients suffering from terminal illness (life expectance < 1 month)
- Patients already included in the study
- Patients who have been stabilized at local hospitals and are referred for second opinion e.g. coronary angiography
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Haukeland University Hospital
Bergen, 5020
Stavanger University Hospital
Stavanger, 4011
About this study
Official title: Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain (WESTCOR Study)
The main aim of the WESTCOR study is to
- investigate the ability of two high sensitive cardiac troponin (hs-cTn) assays to diagnose acute coronary syndrome and predict prognosis in different patient populations (e.g. gender, age and co-morbidity)
- to validate the suggested 1 hour protocol for rule in and rule out of acute coronary syndrome for two hs-cTn assays in an unselected chest pain population
- to investigate different biomarkers ability to predict long term prognosis after hospitalization for chest pain
Read the detailed description
The WESTCOR-study will include patients presenting to the Emergency Department of Haukeland University Hospital and Stavanger University Hospital with symptoms indicative of acute coronary syndrome. 1500 patients will be included at Haukeland University Hospital and 400 at Stavanger University Hospital. The two locations use different high sensitive troponin assays (i.e. hs-cTnT and hs-cTnI (Abbott Diagnostics) for routine diagnostic of coronary syndrome.
1900 patients will be sampled and hs-cTnT or hs-cTnI (as applicable) will be measured at admission, after one (2/3 of the cohort), three hours and after 8-12 hours. Clinicians will be blinded to the results of the hs-cTn assay that is not used as routine assay locally. Final diagnosis will be made by two independent cardiologists based on all available clinical information and results of the routine tests. The ability to diagnose or exclude MI ACS, and MACE at different sampling points in different patient populations will be compared for different biomarkers. 1500 patients will have a sample 1 hour after admission. The clinicians will be blinded to the results of this sample (both hs-cTn assays). The ability of the one-hour sample to diagnose or exclude myocardial infraction (MI), ACS and MACE will be compared between biomarkers.
All patients will be invited to take a follow-up sample 3 months after discharge.
The patients will further be followed for 1-5 years through national registers and the prognostic value of hs-cTn concentrations and dynamics as well as other biomarkers, will be measured.
- Conditions
- Acute Coronary Syndrome
- Keywords
- Troponin, Myocardial infarction
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with chest pain that are diagnosed with acute coronary syndrome based on troponin concentrations
Stratified according to gender, age and co-morbidities
Measured: 1-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionMay 2020
- Study completionMay 2020
Why it stopped: It was no longer possible to include patients due to logistic challanges occuring during the Covid-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Stavanger HF, The Royal Norwegian Ministry of Health
- Responsible party
- Sponsor
- Investigators
- Kristin M Aakre, MD, PhD, Principal investigator, Laboratory of Clinical Biochemistry, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620202
- Sponsor's protocol ID
- 2014/1365
- Acronym
- WESTCOR
- Status last verified
- Jul 2020
- First submitted
- 12 Oct 2015
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Restan IZ, Tew YY, Steiro OT, Li Z, Tjora HL, Langorgen J, Omland T, Collinson P, Bjorneklett R, Vikenes K, Steinsvik T, Skadberg O, Mjelva OR, Larsen AI, Bonarjee VVS, Mills NL, Aakre KM. Exploring Sex-Specific High-Sensitivity Cardiac Troponin Thresholds for Rule-Out of Non-ST-Elevation Myocardial Infarction. Clin Chem. 2026 Aug 3;72(8):868-879. doi: 10.1093/clinchem/hvag030.
PubMed 42135070Saeed N, Restan IZ, Steiro OT, Tjora HL, Langorgen J, Skadberg O, Mjelva OR, Bonarjee VVS, Bjorneklett RO, Steinsvik T, Vikenes K, Omland T, Apple FS, Jaffe AS, Mills NL, Collinson PO, Kavsak PA, Aakre KM. Analytical Error of Cardiac Troponin and Impact on the Performance of Accelerated Diagnostic Protocols in Patients with Acute Chest Pain. Clin Chem. 2025 Dec 2;71(12):1243-1256. doi: 10.1093/clinchem/hvaf116.
PubMed 41092105Saeed N, Steiro OT, Langorgen J, Tjora HL, Bjorneklett RO, Skadberg O, Bonarjee VVS, Mjelva OR, Norekval TM, Steinsvik T, Vikenes K, Omland T, Aakre KM. Diagnosing Myocardial Injury in an Acute Chest Pain Cohort; Long-Term Prognostic Implications of Cardiac Troponin T and I. Clin Chem. 2024 Oct 3;70(10):1241-1255. doi: 10.1093/clinchem/hvae110.
PubMed 39119917Saeed N, Norekval TM, Steiro OT, Tjora HL, Langorgen J, Bjorneklett RO, Skadberg O, Bonarjee VVS, Mjelva OR, Omland T, Vikenes K, Aakre KM. Predictors of long-term symptom burden and quality of life in patients hospitalised with chest pain: a prospective observational study. BMJ Open. 2022 Jul 13;12(7):e062302. doi: 10.1136/bmjopen-2022-062302.
PubMed 35831040Steiro OT, Aakre KM, Tjora HL, Bjorneklett RO, Skadberg O, Bonarjee VVS, Mjelva OR, Omland T, Vikenes K, Langorgen J. Association between symptoms and risk of non-ST segment elevation myocardial infarction according to age and sex in patients admitted to the emergency department with suspected acute coronary syndrome: a single-centre retrospective cohort study. BMJ Open. 2022 May 12;12(5):e054185. doi: 10.1136/bmjopen-2021-054185.
PubMed 35551077
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. 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 (WESTCOR Study)
- ClinicalTrials.gov ID
- NCT02620202
- Acronym / sponsor ID
- WESTCOR / 2014/1365
- Conditions
- Acute Coronary Syndrome
- Keywords
- Troponin, Myocardial infarction
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: It was no longer possible to include patients due to logistic challanges occuring during the Covid-19 pandemic
- Enrolment
- 1,900 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Helse Stavanger HF, The Royal Norwegian Ministry of Health
- Study start
- Sep 2015 (actual)
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 2 Dec 2015 (estimated)
- 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 main aim of the WESTCOR study is to
- investigate the ability of two high sensitive cardiac troponin (hs-cTn) assays to diagnose acute coronary syndrome and predict prognosis in different patient populations (e.g. gender, age and co-morbidity)
- to validate the suggested 1 hour protocol for rule in and rule out of acute coronary syndrome for two hs-cTn assays in an unselected chest pain population
- to investigate different biomarkers ability to predict long term prognosis after hospitalization for chest pain
Detailed description
The WESTCOR-study will include patients presenting to the Emergency Department of Haukeland University Hospital and Stavanger University Hospital with symptoms indicative of acute coronary syndrome. 1500 patients will be included at Haukeland University Hospital and 400 at Stavanger University Hospital. The two locations use different high sensitive troponin assays (i.e. hs-cTnT and hs-cTnI (Abbott Diagnostics) for routine diagnostic of coronary syndrome.
1900 patients will be sampled and hs-cTnT or hs-cTnI (as applicable) will be measured at admission, after one (2/3 of the cohort), three hours and after 8-12 hours. Clinicians will be blinded to the results of the hs-cTn assay that is not used as routine assay locally. Final diagnosis will be made by two independent cardiologists based on all available clinical information and results of the routine tests. The ability to diagnose or exclude MI ACS, and MACE at different sampling points in different patient populations will be compared for different biomarkers. 1500 patients will have a sample 1 hour after admission. The clinicians will be blinded to the results of this sample (both hs-cTn assays). The ability of the one-hour sample to diagnose or exclude myocardial infraction (MI), ACS and MACE will be compared between biomarkers.
All patients will be invited to take a follow-up sample 3 months after discharge.
The patients will further be followed for 1-5 years through national registers and the prognostic value of hs-cTn concentrations and dynamics as well as other biomarkers, will be measured.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Emergency Department at Haukeland University Hospital or Stavanger University Hospital with symptoms indicative of acute coronary syndrome
Key inclusion criteria (2 listed)
- Patients admitted to the Emergency Department with a clinical suspicion of acute coronary syndrome i.e. chest pain or pain radiating down the arms, the back, into the jaw, throat or into the lower teeth. Chest pain must not be the most dominant symptom but may or may not be combined with e.g. dyspnea, nausea, anxiousness or palpitations.
- Age >= 18 years
Key exclusion criteria (6 listed)
- ST elevation MI
- Age < 18 years
- Patients not able to give informed consent
- Patients suffering from terminal illness (life expectance < 1 month)
- Patients already included in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with chest pain that are diagnosed with acute coronary syndrome based on troponin concentrations
Time frame: 1-3 hours
Stratified according to gender, age and co-morbidities
Results and safety
The study was stopped early (reason given: It was no longer possible to include patients due to logistic challanges occuring during the Covid-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 42135070Restan IZ, Tew YY, Steiro OT, Li Z, Tjora HL, Langorgen J, Omland T, Collinson P, Bjorneklett R, Vikenes K, Steinsvik T, Skadberg O, Mjelva OR, Larsen AI, Bonarjee VVS, Mills NL, Aakre KM. Exploring Sex-Specific High-Sensitivity Cardiac Troponin Thresholds for Rule-Out of Non-ST-Elevation Myocardial Infarction. Clin Chem. 2026 Aug 3;72(8):868-879. doi: 10.1093/clinchem/hvag030.
- Derived from this study: PubMed 41092105Saeed N, Restan IZ, Steiro OT, Tjora HL, Langorgen J, Skadberg O, Mjelva OR, Bonarjee VVS, Bjorneklett RO, Steinsvik T, Vikenes K, Omland T, Apple FS, Jaffe AS, Mills NL, Collinson PO, Kavsak PA, Aakre KM. Analytical Error of Cardiac Troponin and Impact on the Performance of Accelerated Diagnostic Protocols in Patients with Acute Chest Pain. Clin Chem. 2025 Dec 2;71(12):1243-1256. doi: 10.1093/clinchem/hvaf116.
- Derived from this study: PubMed 39119917Saeed N, Steiro OT, Langorgen J, Tjora HL, Bjorneklett RO, Skadberg O, Bonarjee VVS, Mjelva OR, Norekval TM, Steinsvik T, Vikenes K, Omland T, Aakre KM. Diagnosing Myocardial Injury in an Acute Chest Pain Cohort; Long-Term Prognostic Implications of Cardiac Troponin T and I. Clin Chem. 2024 Oct 3;70(10):1241-1255. doi: 10.1093/clinchem/hvae110.
- Derived from this study: PubMed 35831040Saeed N, Norekval TM, Steiro OT, Tjora HL, Langorgen J, Bjorneklett RO, Skadberg O, Bonarjee VVS, Mjelva OR, Omland T, Vikenes K, Aakre KM. Predictors of long-term symptom burden and quality of life in patients hospitalised with chest pain: a prospective observational study. BMJ Open. 2022 Jul 13;12(7):e062302. doi: 10.1136/bmjopen-2022-062302.
- Derived from this study: PubMed 35551077Steiro OT, Aakre KM, Tjora HL, Bjorneklett RO, Skadberg O, Bonarjee VVS, Mjelva OR, Omland T, Vikenes K, Langorgen J. Association between symptoms and risk of non-ST segment elevation myocardial infarction according to age and sex in patients admitted to the emergency department with suspected acute coronary syndrome: a single-centre retrospective cohort study. BMJ Open. 2022 May 12;12(5):e054185. doi: 10.1136/bmjopen-2021-054185.
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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
Laboratory of Clinical Biochemistry, Haukeland University Hospital
2 sites 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, run by Haukeland University Hospital at 2 sites 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 2 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: stopped early, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 was stopped early (reason given: It was no longer possible to include patients due to logistic challanges occuring during the Covid-19 pandemic). Results are not available in the source record.
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?
Number of patients with chest pain that are diagnosed with acute coronary syndrome based on troponin concentrations (time frame: 1-3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02620202, which also lists 5 linked publications.
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 28 Apr 2021.