- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05354804
Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain Using Point of Care Assays (WESTCOR-POC)
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kristin M Aakre, MD/PhD
- Phone Number: +4755974387
- Email: kristin.moberg.aakre@helse-bergen.no
Study Contact Backup
- Name: Rune O Bjørneklett, Professor
- Phone Number: +4755975000
- Email: rune.oskar.bjorneklett@helse-bergen.no
Study Locations
-
-
-
Bergen, Norway, 5020
- Recruiting
- Haukeland University Hospital
-
Contact:
- Kristin M Aakre, MD, PhD
- Phone Number: +4755973188
- Email: kristin.moberg.aakre@helse-bergen.no
-
Contact:
- Kjell Vikenes, MD, PhD
- Phone Number: +4755972172
- Email: kjell.vikenes@helse-bergen.no
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients > 17 years who are referred to the Emergency Department of Haukeland University Hospital with chest pain suspect of ACS
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Standard
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.
|
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.
|
Active Comparator: POC
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite of myocardial infarction, death and revascularization
Time Frame: 30 days
|
Differences in composite of death, myocardial infarction and acute revascularization within 30 days will be compared between the two arms.
|
30 days
|
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
|
Up to 24 hours
|
Patients quality of life according to RAND-12
Time Frame: 30 days
|
Patients quality of life will be measured 30 days after discharge using RAND-12 questionnaire and compared between the two arms.
|
30 days
|
Symptom burden
Time Frame: 30 days
|
Patients quality of life will be measured 30 days after discharge using SAQ7 questionnaire and compared between the two arms
|
30 days
|
Patient satisfaction
Time Frame: 30 days
|
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
|
30 days
|
Total patient episode costs
Time Frame: Up to 3 months
|
Total patient episode costs will be calculated and compared between the two arms
|
Up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite of myocardial infarction, death and revascularization
Time Frame: 1 year
|
Death, myocardial infarction or acute revascularization within 12 months after inclusion will be compared between the two arms
|
1 year
|
Discharge rate at 3 hours
Time Frame: 3 hours
|
Percentages of patients who are discharged within 3 hours will be compared between the two arms
|
3 hours
|
Discharge rate at 6 hours
Time Frame: 6 hours
|
Percentages of patients who are discharged within 6 hours will be compared between the two arms
|
6 hours
|
Total length of stay
Time Frame: Up to 3 months
|
Time from arrival in the ED to discharge from hospital (hours) will be compared between the two arms
|
Up to 3 months
|
12 months costs
Time Frame: 12 months
|
Costs related to all hospital contacts during 12 months follow-up
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kristin M Aakre, MD/PhD, Haukeland University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 285544
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Coronary Syndrome
-
Yonsei UniversityRecruitingCoronary Artery Disease, Acute Coronary SyndromeKorea, Republic of
-
Meditrix CorpNational University of Ireland, Galway, Ireland; Boston Scientific Japan K.K.; Fujita Health UniversityRecruitingChronic Coronary Syndrome | Non ST Segment Elevation Acute Coronary SyndromeJapan, Ireland
-
OrbusNeichDuke Clinical Research Institute; OrbusNeich Medical K.K.CompletedCoronary Arteriosclerosis | Non ST Segment Elevation Acute Coronary SyndromeUnited States, Japan
-
Medical University of WarsawRecruitingAcute Coronary Syndrome | Chronic Coronary Syndrome | Non ST Segment Elevation Acute Coronary SyndromePoland
-
Niguarda HospitalCompletedAcute Coronary Syndrome With ST Elevation on Electrocardiogram | Acute Coronary Syndrome Without ST Elevation on Electrocardiogram | Noncritical Coronary Artery Disease Coronary Stenosis Less Than 50 Per Cent | Aortic AneurysmsItaly
-
Eli Lilly and CompanyDaiichi Sankyo, Inc.CompletedCoronary Arteriosclerosis | Acute Coronary SyndromesUnited States
-
University of PatrasCompletedCoronary Artery Disease (CAD) | Acute Coronary Syndrome (ACS)Greece
-
Sohag UniversityRecruitingLeft Main Coronary Artery Disease With Acute Coronary SyndromeEgypt
-
IHF GmbH - Institut für HerzinfarktforschungCompletedAcute Coronary Syndrome (ACS)Germany
-
Bristol-Myers SquibbCompletedAcute Coronary Syndrome (ACS)Canada, Italy, Poland, Sweden, United States, Spain, Austria, Denmark, France, Belgium, Israel, Germany, Russian Federation, United Kingdom
Clinical Trials on Troponin T (Roche Diagnostics) 0/1 hour ESC algorithm
-
Liverpool University Hospitals NHS Foundation TrustAbbott Diagnostics Division; Quidel Corporation; Siemens Corporation, Corporate... and other collaboratorsRecruitingChest Pain | Acute Coronary Syndrome | Troponin | Point-of-care SystemsUnited Kingdom
-
University Hospital, Basel, SwitzerlandRecruitingNSTEMI - Non-ST Segment Elevation MI | Acute Chest PainUnited Kingdom, Switzerland, Spain, Korea, Republic of, United States, Australia, Austria, Finland, Greece, Italy, Romania