Aiming Towards Evidence Based Interpretation of Cardiac B... | NCT02620202

Studies
Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain

NCT02620202

Sponsor

Haukeland University Hospital

Status

Terminated

Last Update Posted

Apr 28, 2021Actual

Enrollment

1,900Actual

Phase

Not provided

Conditions

Acute Coronary Syndrome

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

It was no longer possible to include patients due to logistic challanges occuring during the Covid-19 pandemic

Expanded Access Info

Start Date

Sep 2015Actual

Primary Completion Date

May 2020Actual

Completion Date

May 2020Actual

First Submitted Date

Oct 12, 2015

First Submission Date that Met QC Criteria

Nov 30, 2015

First Posted Date

Dec 2, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2021

Last Update Posted Date

Apr 28, 2021Actual

Name	Class
Helse Stavanger HF	OTHER_GOV
The Royal Norwegian Ministry of Health	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,900Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Number of patients with chest pain that are diagnosed with NSTEMI based on troponin concentration	Stratified according to gender, age and co-morbidities	1-3 hours
Total mortality	Patients will be followed for 1-5 years through national registers

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kristin M Aakre, MD, PhD	Laboratory of Clinical Biochemistry, Haukeland University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Haukeland University Hospital		Bergen		5020	Norway
Stavanger University Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42135070	Derived	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 May 15:hvag030. doi: 10.1093/clinchem/hvag030. Online ahead of print.
41092105

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

ID	Term
D054058	Acute Coronary Syndrome
D009203	Myocardial Infarction