Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-03-02 @ 4:23 PM
Study NCT ID:
NCT02620202
Status:
TERMINATED
Last Update Posted:
2021-04-28
First Post:
2015-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Full blood, Serum samples, EDTA plasma, Urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1900}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'It was no longer possible to include patients due to logistic challanges occuring during the Covid-19 pandemic', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2015-10-12', 'studyFirstSubmitQcDate': '2015-11-30', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of patients with chest pain that are diagnosed with NSTEMI based on troponin concentration', 'timeFrame': '1-3 hours', 'description': 'Stratified according to gender, age and co-morbidities'}, {'measure': 'Total mortality', 'timeFrame': '5 years', 'description': 'Patients will be followed for 1-5 years through national registers'}, {'measure': 'The incidence of major cardiovascular events (MACE) defined as (composite endpoint including MI, UAP, stable angina (requiring hospitalization), revascularization, stroke, heart failure and cardiac arrhythmias)', 'timeFrame': '5 years', 'description': 'Patients will be followed for 1-5 years through national registers'}, {'measure': 'Cardiovascular mortality', 'timeFrame': '5 years', 'description': 'Patients will be followed for 1-5 years through national registers'}, {'measure': 'The incidence of major coronary events defined as (composite endpoint including MI, UAP, stable angina (requiring hospitalization), revascularization)', 'timeFrame': '5 years', 'description': 'Patients will be followed for 1-5 years through national registers'}], 'primaryOutcomes': [{'measure': 'Number of patients with chest pain that are diagnosed with acute coronary syndrome based on troponin concentrations', 'timeFrame': '1-3 hours', 'description': 'Stratified according to gender, age and co-morbidities'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Troponin', 'Myocardial infarction'], 'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '41092105', 'type': 'DERIVED', 'citation': 'Saeed 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.'}, {'pmid': '39119917', 'type': 'DERIVED', 'citation': 'Saeed 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.'}, {'pmid': '35831040', 'type': 'DERIVED', 'citation': 'Saeed 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.'}, {'pmid': '35551077', 'type': 'DERIVED', 'citation': 'Steiro 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.'}]}, 'descriptionModule': {'briefSummary': 'The main aim of the WESTCOR study is to\n\n* 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)\n* 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\n* to investigate different biomarkers ability to predict long term prognosis after hospitalization for chest pain', 'detailedDescription': '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.\n\n1900 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.\n\nAll patients will be invited to take a follow-up sample 3 months after discharge.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the Emergency Department at Haukeland University Hospital or Stavanger University Hospital with symptoms indicative of acute coronary syndrome', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Age \\>= 18 years\n\nExclusion Criteria:\n\n* ST elevation MI\n* Age \\< 18 years\n* Patients not able to give informed consent\n* Patients suffering from terminal illness (life expectance \\< 1 month)\n* Patients already included in the study\n* Patients who have been stabilized at local hospitals and are referred for second opinion e.g. coronary angiography'}, 'identificationModule': {'nctId': 'NCT02620202', 'acronym': 'WESTCOR', 'briefTitle': 'Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain (WESTCOR Study)', 'orgStudyIdInfo': {'id': '2014/1365'}}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'zip': '4011', 'city': 'Stavanger', 'country': 'Norway', 'facility': 'Stavanger University Hospital', 'geoPoint': {'lat': 58.97005, 'lon': 5.73332}}], 'overallOfficials': [{'name': 'Kristin M Aakre, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laboratory of Clinical Biochemistry, Haukeland University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helse Stavanger HF', 'class': 'OTHER_GOV'}, {'name': 'The Royal Norwegian Ministry of Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}