Ignite Creation Date:
2024-05-06 @ 8:39 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02789904
Status:
COMPLETED
Last Update Posted:
2021-04-19
First Post:
2016-05-31
Brief Title:
Evaluation of hsTnI in the Management of Patients With Chest Pain in the Emergency Department
Sponsor:
National Heart Centre Singapore
Organization:
National Heart Centre Singapore
Study Overview
Official Title:
Evaluation of High Sensitivity Troponin I hsTnI in the Management of Patients With Chest Pain in the Emergency Department
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
hsTnI
Brief Summary:
Current standard of care algorithm using high sensitivity troponin T hsTnT requires up to 65 hours to diagnose an ACS Data will be stratified based upon time of symptom onset and gender A health economics and outcome model will be applied using the optimal high sensitivity troponin I hsTnI cut-off values and draw times to determine the cost and outcome benefits predicted from optimal utilization of hsTnI
A chest pain registry will be set up to compare high sensitivity troponin I hsTnI versus high sensitivity troponin T hsTnT for all patients who present to the emergency department and require a blood draw The outcomes of these patients will be tracked over the study period
The purpose of conducting this study evaluation is
1 To shorten the chest pain protocol for suitable patients to 3 hours compared to the current 6 hours protocol with the latest high sensitivity Troponin I assays
2 To determine the validity of Abbott ARCHITECT i2000 and Beckman Coulter ACCESS AccuTnI3 with an accelerated algorithm in comparison to the standard of care acute coronary syndrome ACS algorithm and high sensitivity troponin T hsTnT assay to rule-out or rule-in for an ACS within 3 hours of presentation to the emergency room ER with isolated suspected ACS
3 To establish the local reference norms for hsTnI assays
A chest pain registry will be set up to compare high sensitivity troponin I hsTnI versus high sensitivity troponin T hsTnT for all patients who present to the emergency department and require a blood draw The outcomes of these patients will be tracked over the study period
The purpose of conducting this study evaluation is
1 To shorten the chest pain protocol for suitable patients to 3 hours compared to the current 6 hours protocol with the latest high sensitivity Troponin I assays
2 To determine the validity of Abbott ARCHITECT i2000 and Beckman Coulter ACCESS AccuTnI3 with an accelerated algorithm in comparison to the standard of care acute coronary syndrome ACS algorithm and high sensitivity troponin T hsTnT assay to rule-out or rule-in for an ACS within 3 hours of presentation to the emergency room ER with isolated suspected ACS
3 To establish the local reference norms for hsTnI assays
Detailed Description:
Purpose
Current standard of care algorithm using high sensitivity troponin T hsTnT requires up to 65 hours to diagnose an ACS Data will be stratified based upon time of symptom onset and gender A health economics and outcome model will be applied using the optimal high sensitivity troponin I hsTnI cut-off values and draw times to determine the cost and outcome benefits predicted from optimal utilization of hsTnI
A chest pain registry will be set up to compare high sensitivity troponin I hsTnI versus high sensitivity troponin T hsTnT for all patients who present to the emergency department and require a blood draw The outcomes of these patients will be tracked over the study period
The purpose of conducting this study evaluation is
1 To shorten the chest pain protocol for suitable patients to 3 hours compared to the current 6 hours protocol with the latest high sensitivity Troponin I assays
2 To determine the validity of Abbott ARCHITECT i2000 and Beckman Coulter ACCESS AccuTnI3 with an accelerated algorithm in comparison to the standard of care acute coronary syndrome ACS algorithm and high sensitivity troponin T hsTnT assay to rule-out or rule-in for an ACS within 3 hours of presentation to the emergency room ER with isolated suspected ACS
3 To establish the local reference norms for hsTnI assays
Additionally this study will also seek to validate the use of a 3-D Vector ECG system developed by Ngee Ann Polytechnic to see whether improved sensitivity and specificity for the diagnosis of myocardial infarction on ECG can be achieved using vectorcardiography rather than conventional 12-lead ECG recordings
20 Scope
Under the current clinical algorithm at Singapore General Hospital ambulatory chest pain patients CPP receive an initial evaluation upon presentation to the ER that includes an ECG and blood draw The lab spins and holds the blood to await add-on orders for cardiac markers if clinically-indicated Other chest pain patients arriving by ambulance may have ECG taken in the ambulance and the results faxed ahead to the ER Those that have an initial ECG consistent with an ST-elevation myocardial infarction STEMI receive immediate intervention Patients that do not have STEMI identified are evaluated by an ER physician as soon as possible for clinical signs and symptoms of ACS as well as other diagnoses that require clinical treatment andor hospital admission Patients with suspected ACS require serial Troponin measurements as essential information for the rule-in or rule-out of a non-ST elevation myocardial infarction NSTEMI After seeing the patient the ER physicians will add-on an hsTnT measurement to the sample drawn at presentation and held in the lab This second hsTnT value is drawn two hours after presentation Using the current standard of care hsTnT assay and the universal definition an acute MI at Singapore General Hospital is defined as a troponin rise andor fall with at least one value above 30pgmL with symptoms suggestive of myocardial ischemia There is no clear definition of the amount of rise or fall that is required The reference range for a single troponin T measurement at Singapore General Hospital is currently defined as abnormal if above 30pgmL This study will compare the ARCHITECT hsTnI assay and Beckman Coulter ACCESS AccuTnI3 assays using respective Abbott ARCHITECT and Beckman Coulter UniCel DxI 800 immunoassay systems with hsTnT using Roche analyzer
Troponin I is a sensitive marker of myocardial necrosis which will be elevated due to an intraluminal coronary thrombus related to atherosclerotic plaque rupture or other spontaneous coronary artery disease CAD event MI Type I STEMI patients will be excluded from this study The scope of this study will be limited to the rule-in and rule-out of NSTEMI in ER patients with suspected ACS and no other known causes for elevated troponin
Healthcare data sets and Singapore General Hospital cost data will be used to assess the cost impact of an alternative model for NSTEMI diagnosis with a more aggressive hsTnI algorithm A 30 day Year 1 2 and 5 follow-up phone contact in conjunction with medical record review and screening data will be used by cardiologists to determine diagnosis and confirm patient outcome
Non-ST Elevation Myocardial Infarctions NSTEMIs have subtle changes in morphologies that may not be obvious on a 12-lead ECG This limits the 12-lead ECGs ability to affirmatively indicate the presence or absence of NSTEMIs The 3-D Vector ECG system developed by Ngee Ann Polytechnic which has similarities to vector cardiography VCG ie the Frank lead system is postulated to have better sensitivity to MI than the routine 12-lead ECG Modern graphical user interface techniques used by the 3-D Vector ECG system makes interpretation easier than VCG Additionally since the electrode placements are identical to a 12-lead ECG The clinical procedure for acquiring the signals is not disrupted increasing its viability for integration into existing workflow
30 Study Design and Procedures
Chest pain patients will be identified and consented in the ER waiting area following initial triage and exclusion of STEMI and within 1 hour of initial blood draw at presentation For chest pain registry coordinators will also invite NHCS inpatients to participate The Clinical Coordinators under the guidance of Study Team investigators will be responsible to identify appropriate study candidates to join this study They will assist the study team investigators to explain the purpose of the study and obtain informed consent for additional blood draws as well as a follow-up telephone medical records outcome survey Patients will be invited to join a registry where details regarding their clinical findings relevant investigations and clinical outcomes will be stored for possible future reference in a database Additionally patients will also be asked if a 6-minute ECG can be performed on them The Clinical Coordinators will perform the 3 phlebotomy draws which must occur within the following window periods after the presentation draw to be included in the study
Draw Window period after presentation draw 0h 0-30 min
1 h 60-90 min
2 h 120 - 150 min
Specimens will be collected in 50 ml Gel tubes Serum Separator Tube A total of approximately 15 ml of blood will be collected from each patient The blood sample will be processed at National Heart Centre Singapore NHCS laboratory The clinical coordinators will store each patients serum into 2 separate vials and freeze them in the freezer at -80C The frozen serum samples will be used to perform the hsTnI assays on the Abbott ARCHITECT i2000 analyzer in NHCS and the ACCESS AccuTnI3 assays on the Beckman Coulter UniCel Dxl 800 analyzer in SGH Pathology by the study coordinator and SGH Pathology lab staff respectively
The screening Case Report Form is required for completion and will gather information on 3 key elements 1 chest pain onsetcharacteristics 2 comprehensive demographics to describe the study population and 3 data for TIMI risk score generation Appendix I
To assess the use of 3D-Vector ECG a target of 1000 12-lead ECGs are to be retrieved from the electrocardiographs at SGH Emergency Department triage with the post-analysis to be done at NHCS The retrieved ECGs will be converted to 3D-vector ECG and analysed to extract discriminating parameters which can be reliably used to diagnose and localise the presence of ischaemia Accuracy of the diagnoses will be counter checked with the results of further diagnostic tests performed on the patient in the normal course of treatment From the analysis of these 1000 records the sensitivity and specificity of the 3D-Vector ECG to localise acute coronary syndrome will be computed
40 Lab Test Orders Blood Draws and Analysis
After clinical assessment of the patient by an ER physician an add-on troponin may be ordered for clinical purposes by the physician that will be applied to the time zero presentation blood draw Likewise a 2-hour troponin may be ordered for clinical purposes
Analysis of Beckman Coulter ACCESS AccuTnI3 assays will take place on UniCel DxI 800 immunoassay system in the Singapore General Hospital SGH Pathology Analysis of ARCHITECT hsTnI assay will take place on Abbott ARCHITECT i2000 analyzer in the National Heart Centre Singapore NHCS Laboratory Calibration Calibration verification cross-over validation and daily Quality Control for the hsTnI assay will be performed by medical technologists in conjunction with normal laboratory operations
60 Study Duration
4000 patients are expected to have been included in the study in a period of 5 years from the day of recruitment Recruitment of new patients will end after 4000 patients are enrolled
70 Data Retrieval
Laboratory data will be stored in the SingHealth Information System Extraction of the data will be accomplished by export to an Excel spreadsheet Clinical data will be printed out and entered into a computer database using a standardized case report form
80 Telephone Medical records Follow-up
Study patients will be contacted by telephone medical records on Day 30 Year 1 Year 2 and Year 5 after recruitment for any clinical events or symptoms that will be relevant to adjudication
Current standard of care algorithm using high sensitivity troponin T hsTnT requires up to 65 hours to diagnose an ACS Data will be stratified based upon time of symptom onset and gender A health economics and outcome model will be applied using the optimal high sensitivity troponin I hsTnI cut-off values and draw times to determine the cost and outcome benefits predicted from optimal utilization of hsTnI
A chest pain registry will be set up to compare high sensitivity troponin I hsTnI versus high sensitivity troponin T hsTnT for all patients who present to the emergency department and require a blood draw The outcomes of these patients will be tracked over the study period
The purpose of conducting this study evaluation is
1 To shorten the chest pain protocol for suitable patients to 3 hours compared to the current 6 hours protocol with the latest high sensitivity Troponin I assays
2 To determine the validity of Abbott ARCHITECT i2000 and Beckman Coulter ACCESS AccuTnI3 with an accelerated algorithm in comparison to the standard of care acute coronary syndrome ACS algorithm and high sensitivity troponin T hsTnT assay to rule-out or rule-in for an ACS within 3 hours of presentation to the emergency room ER with isolated suspected ACS
3 To establish the local reference norms for hsTnI assays
Additionally this study will also seek to validate the use of a 3-D Vector ECG system developed by Ngee Ann Polytechnic to see whether improved sensitivity and specificity for the diagnosis of myocardial infarction on ECG can be achieved using vectorcardiography rather than conventional 12-lead ECG recordings
20 Scope
Under the current clinical algorithm at Singapore General Hospital ambulatory chest pain patients CPP receive an initial evaluation upon presentation to the ER that includes an ECG and blood draw The lab spins and holds the blood to await add-on orders for cardiac markers if clinically-indicated Other chest pain patients arriving by ambulance may have ECG taken in the ambulance and the results faxed ahead to the ER Those that have an initial ECG consistent with an ST-elevation myocardial infarction STEMI receive immediate intervention Patients that do not have STEMI identified are evaluated by an ER physician as soon as possible for clinical signs and symptoms of ACS as well as other diagnoses that require clinical treatment andor hospital admission Patients with suspected ACS require serial Troponin measurements as essential information for the rule-in or rule-out of a non-ST elevation myocardial infarction NSTEMI After seeing the patient the ER physicians will add-on an hsTnT measurement to the sample drawn at presentation and held in the lab This second hsTnT value is drawn two hours after presentation Using the current standard of care hsTnT assay and the universal definition an acute MI at Singapore General Hospital is defined as a troponin rise andor fall with at least one value above 30pgmL with symptoms suggestive of myocardial ischemia There is no clear definition of the amount of rise or fall that is required The reference range for a single troponin T measurement at Singapore General Hospital is currently defined as abnormal if above 30pgmL This study will compare the ARCHITECT hsTnI assay and Beckman Coulter ACCESS AccuTnI3 assays using respective Abbott ARCHITECT and Beckman Coulter UniCel DxI 800 immunoassay systems with hsTnT using Roche analyzer
Troponin I is a sensitive marker of myocardial necrosis which will be elevated due to an intraluminal coronary thrombus related to atherosclerotic plaque rupture or other spontaneous coronary artery disease CAD event MI Type I STEMI patients will be excluded from this study The scope of this study will be limited to the rule-in and rule-out of NSTEMI in ER patients with suspected ACS and no other known causes for elevated troponin
Healthcare data sets and Singapore General Hospital cost data will be used to assess the cost impact of an alternative model for NSTEMI diagnosis with a more aggressive hsTnI algorithm A 30 day Year 1 2 and 5 follow-up phone contact in conjunction with medical record review and screening data will be used by cardiologists to determine diagnosis and confirm patient outcome
Non-ST Elevation Myocardial Infarctions NSTEMIs have subtle changes in morphologies that may not be obvious on a 12-lead ECG This limits the 12-lead ECGs ability to affirmatively indicate the presence or absence of NSTEMIs The 3-D Vector ECG system developed by Ngee Ann Polytechnic which has similarities to vector cardiography VCG ie the Frank lead system is postulated to have better sensitivity to MI than the routine 12-lead ECG Modern graphical user interface techniques used by the 3-D Vector ECG system makes interpretation easier than VCG Additionally since the electrode placements are identical to a 12-lead ECG The clinical procedure for acquiring the signals is not disrupted increasing its viability for integration into existing workflow
30 Study Design and Procedures
Chest pain patients will be identified and consented in the ER waiting area following initial triage and exclusion of STEMI and within 1 hour of initial blood draw at presentation For chest pain registry coordinators will also invite NHCS inpatients to participate The Clinical Coordinators under the guidance of Study Team investigators will be responsible to identify appropriate study candidates to join this study They will assist the study team investigators to explain the purpose of the study and obtain informed consent for additional blood draws as well as a follow-up telephone medical records outcome survey Patients will be invited to join a registry where details regarding their clinical findings relevant investigations and clinical outcomes will be stored for possible future reference in a database Additionally patients will also be asked if a 6-minute ECG can be performed on them The Clinical Coordinators will perform the 3 phlebotomy draws which must occur within the following window periods after the presentation draw to be included in the study
Draw Window period after presentation draw 0h 0-30 min
1 h 60-90 min
2 h 120 - 150 min
Specimens will be collected in 50 ml Gel tubes Serum Separator Tube A total of approximately 15 ml of blood will be collected from each patient The blood sample will be processed at National Heart Centre Singapore NHCS laboratory The clinical coordinators will store each patients serum into 2 separate vials and freeze them in the freezer at -80C The frozen serum samples will be used to perform the hsTnI assays on the Abbott ARCHITECT i2000 analyzer in NHCS and the ACCESS AccuTnI3 assays on the Beckman Coulter UniCel Dxl 800 analyzer in SGH Pathology by the study coordinator and SGH Pathology lab staff respectively
The screening Case Report Form is required for completion and will gather information on 3 key elements 1 chest pain onsetcharacteristics 2 comprehensive demographics to describe the study population and 3 data for TIMI risk score generation Appendix I
To assess the use of 3D-Vector ECG a target of 1000 12-lead ECGs are to be retrieved from the electrocardiographs at SGH Emergency Department triage with the post-analysis to be done at NHCS The retrieved ECGs will be converted to 3D-vector ECG and analysed to extract discriminating parameters which can be reliably used to diagnose and localise the presence of ischaemia Accuracy of the diagnoses will be counter checked with the results of further diagnostic tests performed on the patient in the normal course of treatment From the analysis of these 1000 records the sensitivity and specificity of the 3D-Vector ECG to localise acute coronary syndrome will be computed
40 Lab Test Orders Blood Draws and Analysis
After clinical assessment of the patient by an ER physician an add-on troponin may be ordered for clinical purposes by the physician that will be applied to the time zero presentation blood draw Likewise a 2-hour troponin may be ordered for clinical purposes
Analysis of Beckman Coulter ACCESS AccuTnI3 assays will take place on UniCel DxI 800 immunoassay system in the Singapore General Hospital SGH Pathology Analysis of ARCHITECT hsTnI assay will take place on Abbott ARCHITECT i2000 analyzer in the National Heart Centre Singapore NHCS Laboratory Calibration Calibration verification cross-over validation and daily Quality Control for the hsTnI assay will be performed by medical technologists in conjunction with normal laboratory operations
60 Study Duration
4000 patients are expected to have been included in the study in a period of 5 years from the day of recruitment Recruitment of new patients will end after 4000 patients are enrolled
70 Data Retrieval
Laboratory data will be stored in the SingHealth Information System Extraction of the data will be accomplished by export to an Excel spreadsheet Clinical data will be printed out and entered into a computer database using a standardized case report form
80 Telephone Medical records Follow-up
Study patients will be contacted by telephone medical records on Day 30 Year 1 Year 2 and Year 5 after recruitment for any clinical events or symptoms that will be relevant to adjudication
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None