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Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain Using Point of Care Assays (WESTCOR-POC)

Primary Purpose

Acute Coronary Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Troponin I (Siemens VTli) 0/1 hour algorithm
Troponin T (Roche Diagnostics) 0/1 hour ESC algorithm
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients > 17 years who are referred to the Emergency Department of Haukeland University Hospital with chest pain suspect of ACS

Exclusion Criteria:

  1. STEMI (ECG criteria)
  2. Patients without STEMI who are immediately transferred to cardiac catheterisation lab (due to heart failure, arrhythmia etc.) without possibility for blood sampling
  3. Patients admitted from Nursing homes
  4. Patients transferred from other hospitals (e.g. for PCI treatment)
  5. Less than 2 months life expectancy from comorbid clinical conditions
  6. Not possible to provide informed consent due to cognitive impairment, language problems or other reasons

Sites / Locations

  • Haukeland University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Standard

POC

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Composite of myocardial infarction, death and revascularization
Differences in composite of death, myocardial infarction and acute revascularization within 30 days will be compared between the two arms.
Length of stay in the Emergency Department (ED)
Difference in length of stay in the ED will be compared between the two arms
Patients quality of life according to RAND-12
Patients quality of life will be measured 30 days after discharge using RAND-12 questionnaire and compared between the two arms.
Symptom burden
Patients quality of life will be measured 30 days after discharge using SAQ7 questionnaire and compared between the two arms
Patient satisfaction
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
Total patient episode costs
Total patient episode costs will be calculated and compared between the two arms

Secondary Outcome Measures

Composite of myocardial infarction, death and revascularization
Death, myocardial infarction or acute revascularization within 12 months after inclusion will be compared between the two arms
Discharge rate at 3 hours
Percentages of patients who are discharged within 3 hours will be compared between the two arms
Discharge rate at 6 hours
Percentages of patients who are discharged within 6 hours will be compared between the two arms
Total length of stay
Time from arrival in the ED to discharge from hospital (hours) will be compared between the two arms
12 months costs
Costs related to all hospital contacts during 12 months follow-up

Full Information

First Posted
March 22, 2022
Last Updated
August 21, 2023
Sponsor
Haukeland University Hospital
Collaborators
Siemens Corporation, Corporate Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05354804
Brief Title
Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain Using Point of Care Assays
Acronym
WESTCOR-POC
Official Title
Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain Using Point of Care Assays
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
December 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
Collaborators
Siemens Corporation, Corporate Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
POC
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Troponin I (Siemens VTli) 0/1 hour algorithm
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Troponin T (Roche Diagnostics) 0/1 hour ESC algorithm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite of myocardial infarction, death and revascularization
Description
Differences in composite of death, myocardial infarction and acute revascularization within 30 days will be compared between the two arms.
Time Frame
30 days
Title
Length of stay in the Emergency Department (ED)
Description
Difference in length of stay in the ED will be compared between the two arms
Time Frame
Up to 24 hours
Title
Patients quality of life according to RAND-12
Description
Patients quality of life will be measured 30 days after discharge using RAND-12 questionnaire and compared between the two arms.
Time Frame
30 days
Title
Symptom burden
Description
Patients quality of life will be measured 30 days after discharge using SAQ7 questionnaire and compared between the two arms
Time Frame
30 days
Title
Patient satisfaction
Description
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
Time Frame
30 days
Title
Total patient episode costs
Description
Total patient episode costs will be calculated and compared between the two arms
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Composite of myocardial infarction, death and revascularization
Description
Death, myocardial infarction or acute revascularization within 12 months after inclusion will be compared between the two arms
Time Frame
1 year
Title
Discharge rate at 3 hours
Description
Percentages of patients who are discharged within 3 hours will be compared between the two arms
Time Frame
3 hours
Title
Discharge rate at 6 hours
Description
Percentages of patients who are discharged within 6 hours will be compared between the two arms
Time Frame
6 hours
Title
Total length of stay
Description
Time from arrival in the ED to discharge from hospital (hours) will be compared between the two arms
Time Frame
Up to 3 months
Title
12 months costs
Description
Costs related to all hospital contacts during 12 months follow-up
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristin M Aakre, MD/PhD
Phone
+4755974387
Email
kristin.moberg.aakre@helse-bergen.no
First Name & Middle Initial & Last Name or Official Title & Degree
Rune O Bjørneklett, Professor
Phone
+4755975000
Email
rune.oskar.bjorneklett@helse-bergen.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin M Aakre, MD/PhD
Organizational Affiliation
Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5020
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin M Aakre, MD, PhD
Phone
+4755973188
Email
kristin.moberg.aakre@helse-bergen.no
First Name & Middle Initial & Last Name & Degree
Kjell Vikenes, MD, PhD
Phone
+4755972172
Email
kjell.vikenes@helse-bergen.no

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to share individual participant data.

Learn more about this trial

Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain Using Point of Care Assays

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