NCT02620202

Brief 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. 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 12, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

April 28, 2021

Status Verified

July 1, 2020

Enrollment Period

4.7 years

First QC Date

October 12, 2015

Last Update Submit

April 26, 2021

Conditions

Keywords

TroponinMyocardial infarction

Outcome Measures

Primary Outcomes (1)

  • 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

    1-3 hours

Other Outcomes (5)

  • Number of patients with chest pain that are diagnosed with NSTEMI based on troponin concentration

    1-3 hours

  • Total mortality

    5 years

  • 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)

    5 years

  • +2 more other outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to the Emergency Department at Haukeland University Hospital or Stavanger University Hospital with symptoms indicative of acute coronary syndrome

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Haukeland University Hospital

Bergen, 5020, Norway

Location

Stavanger University Hospital

Stavanger, 4011, Norway

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Full blood, Serum samples, EDTA plasma, Urine

MeSH Terms

Conditions

Acute Coronary SyndromeMyocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Kristin M Aakre, MD, PhD

    Laboratory of Clinical Biochemistry, Haukeland University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2015

First Posted

December 2, 2015

Study Start

September 1, 2015

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

April 28, 2021

Record last verified: 2020-07

Locations