Acute Coronary Syndrome, Acute Myocardial Infarction
Conditions
Brief summary
The objective of the study is to evaluate the performance and intended use of a new cardiac biomarker test, Troponin I, in an intended use population. Blood specimens will be tested using the new investigational test that detects the level of Troponin I. Results will be compared to the diagnosis of whether or not an acute myocardial infarction (MI) occurred.
Detailed description
The purpose of the cardiac biomarker Troponin I is to aid in the diagnosis of myocardial infarction.The assay is also intended to assist in the prognosis relative risk to all cause mortality (ACM) and major adverse cardiac events (MACE) consisting of myocardial infarction, revascularization, and cardiac death in patients who present with symptoms suggestive of acute coronary syndrome (ACS) without a diagnosis of myocardial infarction. All specimens were collected under a separate specimen collection protocol (Protocol No, 7B5-02-09A01-01: Clinical Specimen Procurement for Biomarker Evaluation of Suspected ACS). The specimens that will be tested include approximately 8300 specimens collected from 1101 subjects presenting to Emergency Departments with signs and symptoms of Acute Coronary Syndrome and will be provided to the clinical sites performing investigational Troponin I testing.
Interventions
DEVICEARCHITECT STAT High Sensitive Troponin I Assay
Test blood samples from the ARCHITECT STAT High Sensitive Troponin I Assay. Results obtained will be used to assess the prognosis of subjects for risk of ACM/MACE in the timeframes (30 days and 90 days) after the Emergency Department visit. Troponin results will be compared to documented ACM/MACE events at the 30 day and 90 day time points after Emergency Department visit.
Sponsors
Abbott Diagnostics Division
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* presenting to the Emergency Department with symptoms consistent with or suggestive of Acute Coronary Syndrome (ACS) defined as at least 5 minutes of chest pain (or symptoms consistent with myocardial ischemia) up to 6 hours prior to initial evaluation. * an Electrocardiogram (ECG) result within 2 hours of presentation for observation of Acute Coronary Syndrome (ACS). * greater than 18 years of age. * not known to be pregnant. * agreement to the follow-up required by the study.
Exclusion criteria
* prior participation in this study. * require dialysis for end stage renal disease. * history of a previous heart transplant. * coexisting disorder associated with limited life expectancy. * currently participating in another investigational device or drug study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Performance - Area Under the Curve | Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department | The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating the Area Under the Curve (AUC). The Area Under the Curve that was assessed, is used to determine the optimum clinical sensitivity and specificity for the ARCHITECT STAT High Sensitive Troponin-I assay. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator). |
| Clinical Performance- Sensitivity | Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department | The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Sensitivity. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator). |
| Clinical Performance- Specificity | Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department. | The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Specificity. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator). |
| Clinical Performance- Negative Predictive Value (NPV) | Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department. | The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Negative Predictive Value. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator). |
| Clinical Performance- Positive Predictive Value (PPV) | Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department. | The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating the Positive Predictive Value. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prognosis | 30-day and 90-day follow-up | Specimens were collected at 11 EDs from 1,101 subjects presenting to the ED with symptoms consistent with ACS. All subject diagnoses were adjudicated by three board certified cardiologists according to current standard of care. ARCHITECT STAT High Sensitive Troponin I results were generated from subject specimens and evaluated for use as an aid in the assessment of prognosis. Analyses used the first available troponin result from multiple serial draw time points. Subjects were assessed for risk of all cause mortality (ACM) and major adverse cardiac event (MACE) at 30 day and 90 day time points after ED discharge. MACE consisted of myocardial infarction, urgent revascularization, and cardiac death. Subjects were followed-up for subsequent events by medical record review and/or subject/caregiver contact. Any ACM and MACE that occurred during the ED visit and on the same day as ED discharge were not included in the analyses. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ARCHITECT STAT High Sensitive Troponin I Assay Testing All subjects will have their blood tested by the investigational ARCHITECT STAT High Sensitive Troponin I assay. Specimens were collected at 11 emergency departments from 1,101 subjects presenting to the emergency department with symptoms consistent with acute coronary syndrome (ACS). All subject diagnoses were adjudicated by three board certified cardiologists according to current standard of care. | 1,101 |
| Total | 1,101 |
Baseline characteristics
| Characteristic | ARCHITECT STAT High Sensitive Troponin I Assay Testing |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 355 Participants |
| Age, Categorical Between 18 and 65 years | 746 Participants |
| Observed Myocardial Infarction Prevalence Number Participants with Myocardial Infarction | 130 participants |
| Observed Myocardial Infarction Prevalence Number Participants without Myocardial Infarction | 971 participants |
| Race/Ethnicity, Customized Asian | 18 participants |
| Race/Ethnicity, Customized Black | 300 participants |
| Race/Ethnicity, Customized Hispanic | 62 participants |
| Race/Ethnicity, Customized Other | 29 participants |
| Race/Ethnicity, Customized White | 692 participants |
| Sex: Female, Male Female | 482 Participants |
| Sex: Female, Male Male | 619 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,101 |
| serious Total, serious adverse events | 0 / 1,101 |
Outcome results
Primary
Clinical Performance - Area Under the Curve
The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating the Area Under the Curve (AUC). The Area Under the Curve that was assessed, is used to determine the optimum clinical sensitivity and specificity for the ARCHITECT STAT High Sensitive Troponin-I assay. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).
Time frame: Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department
Population: The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Area Under the Curve in K2 EDTA | Clinical Performance - Area Under the Curve | Area Under the Curve: 2-4 hours | 0.9431 Probability |
| Area Under the Curve in K2 EDTA | Clinical Performance - Area Under the Curve | Area Under the Curve: 0-2 hours | 0.9326 Probability |
| Area Under the Curve in K2 EDTA | Clinical Performance - Area Under the Curve | Area Under the Curve: 4-9 hours | 0.9503 Probability |
| Area Under the Curve in Lithium Heparin Separator | Clinical Performance - Area Under the Curve | Area Under the Curve: 2-4 hours | 0.9349 Probability |
| Area Under the Curve in Lithium Heparin Separator | Clinical Performance - Area Under the Curve | Area Under the Curve: 0-2 hours | 0.9197 Probability |
| Area Under the Curve in Lithium Heparin Separator | Clinical Performance - Area Under the Curve | Area Under the Curve: 4-9 hours | 0.9498 Probability |
| Area Under the Curve in Serum Separator | Clinical Performance - Area Under the Curve | Area Under the Curve: 0-2 hours | 0.9412 Probability |
| Area Under the Curve in Serum Separator | Clinical Performance - Area Under the Curve | Area Under the Curve: 4-9 hours | 0.9449 Probability |
| Area Under the Curve in Serum Separator | Clinical Performance - Area Under the Curve | Area Under the Curve: 2-4 hours | 0.9419 Probability |
Comparison: Time point: 0-2 hours95% CI: [0.9048, 0.9604]
Comparison: Time point: 2-4 hours95% CI: [0.9081, 0.9782]
Comparison: Time point: 4-9 hours95% CI: [0.9419, 0.9857]
Comparison: Time point: 0-2 hours95% CI: [0.8914, 0.948]
Comparison: Time point: 2-4 hours95% CI: [0.8986, 0.9712]
Comparison: Time point: 4-9 hours95% CI: [0.919, 0.9805]
Comparison: Time point: 0-2 hours95% CI: [0.9102, 0.9722]
Comparison: Time point: 2-4 hours95% CI: [0.9041, 0.9796]
Comparison: Time point: 4-9 hours95% CI: [0.9046, 0.9852]
Primary
Clinical Performance- Negative Predictive Value (NPV)
The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Negative Predictive Value. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).
Time frame: Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.
Population: The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Area Under the Curve in K2 EDTA | Clinical Performance- Negative Predictive Value (NPV) | % NPV: 2-4 hours | 99.19 %nonMI,TnI</=cutoff vs all TnI</=cutoff |
| Area Under the Curve in K2 EDTA | Clinical Performance- Negative Predictive Value (NPV) | % NPV: 0-2 hours | 98.10 %nonMI,TnI</=cutoff vs all TnI</=cutoff |
| Area Under the Curve in K2 EDTA | Clinical Performance- Negative Predictive Value (NPV) | % NPV: 4-9 hours | 99.23 %nonMI,TnI</=cutoff vs all TnI</=cutoff |
| Area Under the Curve in Lithium Heparin Separator | Clinical Performance- Negative Predictive Value (NPV) | % NPV: 2-4 hours | 99.05 %nonMI,TnI</=cutoff vs all TnI</=cutoff |
| Area Under the Curve in Lithium Heparin Separator | Clinical Performance- Negative Predictive Value (NPV) | % NPV: 0-2 hours | 98.08 %nonMI,TnI</=cutoff vs all TnI</=cutoff |
| Area Under the Curve in Lithium Heparin Separator | Clinical Performance- Negative Predictive Value (NPV) | % NPV: 4-9 hours | 99.24 %nonMI,TnI</=cutoff vs all TnI</=cutoff |
| Area Under the Curve in Serum Separator | Clinical Performance- Negative Predictive Value (NPV) | % NPV: 0-2 hours | 98.73 %nonMI,TnI</=cutoff vs all TnI</=cutoff |
| Area Under the Curve in Serum Separator | Clinical Performance- Negative Predictive Value (NPV) | % NPV: 4-9 hours | 99.25 %nonMI,TnI</=cutoff vs all TnI</=cutoff |
| Area Under the Curve in Serum Separator | Clinical Performance- Negative Predictive Value (NPV) | % NPV: 2-4 hours | 99.20 %nonMI,TnI</=cutoff vs all TnI</=cutoff |
Comparison: Time point: 0-2 hours95% CI: [96.82, 98.95]
Comparison: Time point: 2-4 hours95% CI: [98.25, 99.7]
Comparison: Time point: 4-9 hours95% CI: [98.22, 99.75]
Comparison: Time point: 0-2 hours95% CI: [96.81, 98.95]
Comparison: Time point: 2-4 hours95% CI: [98.05, 99.62]
Comparison: Time point: 4-9 hours95% CI: [98.22, 99.75]
Comparison: Time point: 0-2 hours95% CI: [97.61, 99.42]
Comparison: Time point: 2-4 hours95% CI: [98.27, 99.71]
Comparison: Time point: 4-9 hours95% CI: [98.26, 99.76]
Primary
Clinical Performance- Positive Predictive Value (PPV)
The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating the Positive Predictive Value. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).
Time frame: Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.
Population: The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Area Under the Curve in K2 EDTA | Clinical Performance- Positive Predictive Value (PPV) | % PPV: 2-4 hours | 35.68 %MI,TnI >cutoff vs all TnI > cutoff |
| Area Under the Curve in K2 EDTA | Clinical Performance- Positive Predictive Value (PPV) | % PPV: 0-2 hours | 38.78 %MI,TnI >cutoff vs all TnI > cutoff |
| Area Under the Curve in K2 EDTA | Clinical Performance- Positive Predictive Value (PPV) | % PPV: 4-9 hours | 36.49 %MI,TnI >cutoff vs all TnI > cutoff |
| Area Under the Curve in Lithium Heparin Separator | Clinical Performance- Positive Predictive Value (PPV) | % PPV: 2-4 hours | 35.75 %MI,TnI >cutoff vs all TnI > cutoff |
| Area Under the Curve in Lithium Heparin Separator | Clinical Performance- Positive Predictive Value (PPV) | % PPV: 0-2 hours | 36.82 %MI,TnI >cutoff vs all TnI > cutoff |
| Area Under the Curve in Lithium Heparin Separator | Clinical Performance- Positive Predictive Value (PPV) | % PPV: 4-9 hours | 37.75 %MI,TnI >cutoff vs all TnI > cutoff |
| Area Under the Curve in Serum Separator | Clinical Performance- Positive Predictive Value (PPV) | % PPV: 0-2 hours | 35.84 %MI,TnI >cutoff vs all TnI > cutoff |
| Area Under the Curve in Serum Separator | Clinical Performance- Positive Predictive Value (PPV) | % PPV: 4-9 hours | 35.05 %MI,TnI >cutoff vs all TnI > cutoff |
| Area Under the Curve in Serum Separator | Clinical Performance- Positive Predictive Value (PPV) | % PPV: 2-4 hours | 35.94 %MI,TnI >cutoff vs all TnI > cutoff |
Comparison: Time point: 0-2 hours95% CI: [31.92, 45.98]
Comparison: Time point: 2-4 hours95% CI: [29.03, 42.76]
Comparison: Time point: 4-9 hours95% CI: [29.99, 43.38]
Comparison: Time point: 0-2 hours95% CI: [30.43, 43.56]
Comparison: Time point: 2-4 hours95% CI: [29.43, 42.45]
Comparison: Time point: 4-9 hours95% CI: [31.71, 44.09]
Comparison: Time point: 0-2 hours95% CI: [28.7, 43.47]
Comparison: Time point: 2-4 hours95% CI: [29.16, 43.16]
Comparison: Time point: 4-9 hours95% CI: [28.36, 42.21]
Primary
Clinical Performance- Sensitivity
The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Sensitivity. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).
Time frame: Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department
Population: The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Area Under the Curve in K2 EDTA | Clinical Performance- Sensitivity | % Sensitivity: 2-4 hours | 92.21 percentage MI withTnI >cutoff vs all MI |
| Area Under the Curve in K2 EDTA | Clinical Performance- Sensitivity | % Sensitivity: 0-2 hours | 84.44 percentage MI withTnI >cutoff vs all MI |
| Area Under the Curve in K2 EDTA | Clinical Performance- Sensitivity | % Sensitivity: 4-9 hours | 93.90 percentage MI withTnI >cutoff vs all MI |
| Area Under the Curve in Lithium Heparin Separator | Clinical Performance- Sensitivity | % Sensitivity: 2-4 hours | 91.86 percentage MI withTnI >cutoff vs all MI |
| Area Under the Curve in Lithium Heparin Separator | Clinical Performance- Sensitivity | % Sensitivity: 0-2 hours | 85.26 percentage MI withTnI >cutoff vs all MI |
| Area Under the Curve in Lithium Heparin Separator | Clinical Performance- Sensitivity | % Sensitivity: 4-9 hours | 94.95 percentage MI withTnI >cutoff vs all MI |
| Area Under the Curve in Serum Separator | Clinical Performance- Sensitivity | % Sensitivity: 0-2 hours | 87.32 percentage MI withTnI >cutoff vs all MI |
| Area Under the Curve in Serum Separator | Clinical Performance- Sensitivity | % Sensitivity: 4-9 hours | 93.15 percentage MI withTnI >cutoff vs all MI |
| Area Under the Curve in Serum Separator | Clinical Performance- Sensitivity | % Sensitivity: 2-4 hours | 92.00 percentage MI withTnI >cutoff vs all MI |
Comparison: Time point: 0-2 hours95% CI: [75.28, 91.23]
Comparison: Time point: 2-4 hours83.81% CI: [83.81, 97.09]
Comparison: Time point: 4-9 hours95% CI: [86.34, 97.99]
Comparison: Time point: 0-2 hours95% CI: [76.51, 91.7]
Comparison: Time point: 2-4 hours95% CI: [83.95, 96.66]
Comparison: Time point: 4-9 hours95% CI: [88.61, 98.34]
Comparison: Time point: 0-2 hours95% CI: [77.3, 94.04]
Comparison: Time point: 2-4 hours95% CI: [83.4, 97.01]
Comparison: Time point: 4-9 hours95% CI: [84.74, 97.74]
Primary
Clinical Performance- Specificity
The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Specificity. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).
Time frame: Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.
Population: The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Area Under the Curve in K2 EDTA | Clinical Performance- Specificity | % Specificity: 2-4 hours | 85.20 % nonMI with TnI </= cutoff vs all nonMI |
| Area Under the Curve in K2 EDTA | Clinical Performance- Specificity | % Specificity: 0-2 hours | 85.73 % nonMI with TnI </= cutoff vs all nonMI |
| Area Under the Curve in K2 EDTA | Clinical Performance- Specificity | % Specificity: 4-9 hours | 82.82 % nonMI with TnI </= cutoff vs all nonMI |
| Area Under the Curve in Lithium Heparin Separator | Clinical Performance- Specificity | % Specificity: 2-4 hours | 83.72 % nonMI with TnI </= cutoff vs all nonMI |
| Area Under the Curve in Lithium Heparin Separator | Clinical Performance- Specificity | % Specificity: 0-2 hours | 83.76 % nonMI with TnI </= cutoff vs all nonMI |
| Area Under the Curve in Lithium Heparin Separator | Clinical Performance- Specificity | % Specificity: 4-9 hours | 80.72 % nonMI with TnI </= cutoff vs all nonMI |
| Area Under the Curve in Serum Separator | Clinical Performance- Specificity | % Specificity: 0-2 hours | 86.35 % nonMI with TnI </= cutoff vs all nonMI |
| Area Under the Curve in Serum Separator | Clinical Performance- Specificity | % Specificity: 4-9 hours | 84.05 % nonMI with TnI </= cutoff vs all nonMI |
| Area Under the Curve in Serum Separator | Clinical Performance- Specificity | % Specificity: 2-4 hours | 85.81 % nonMI with TnI </= cutoff vs all nonMI |
Comparison: Time point: 0-2 hours95% CI: [83.18, 88.03]
Comparison: Time point: 2-4 hours95% CI: [82.66, 87.5]
Comparison: Time point: 4-9 hours95% CI: [79.99, 85.4]
Comparison: Time point: 0-2 hours95% CI: [81.12, 86.17]
Comparison: Time point: 2-4 hours95% CI: [81.09, 86.11]
Comparison: Time point: 4-9 hours95% CI: [77.82, 83.39]
Comparison: Time point: 0-2 hours95% CI: [83.79, 88.63]
Comparison: Time point: 2-4 hours95% CI: [83.31, 88.07]
Comparison: Time point: 4-9 hours95% CI: [81.31, 86.54]
Secondary
Prognosis
Specimens were collected at 11 EDs from 1,101 subjects presenting to the ED with symptoms consistent with ACS. All subject diagnoses were adjudicated by three board certified cardiologists according to current standard of care. ARCHITECT STAT High Sensitive Troponin I results were generated from subject specimens and evaluated for use as an aid in the assessment of prognosis. Analyses used the first available troponin result from multiple serial draw time points. Subjects were assessed for risk of all cause mortality (ACM) and major adverse cardiac event (MACE) at 30 day and 90 day time points after ED discharge. MACE consisted of myocardial infarction, urgent revascularization, and cardiac death. Subjects were followed-up for subsequent events by medical record review and/or subject/caregiver contact. Any ACM and MACE that occurred during the ED visit and on the same day as ED discharge were not included in the analyses.
Time frame: 30-day and 90-day follow-up
Population: 30 Day and 90-day prognosis (Kaplan Meier analysis) and Hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) are summarized. \*Censored is defined as the subject has not experienced ACM/MACE at the indicated follow-up time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Area Under the Curve in K2 EDTA | Prognosis | MACE/ACM with Troponin value </= cutoff | 19 participants |
| Area Under the Curve in K2 EDTA | Prognosis | No MACE/ACM (*Censored) with TnI value </= cutoff | 802 participants |
| Area Under the Curve in K2 EDTA | Prognosis | MACE/ACM with Troponin value > cutoff | 17 participants |
| Area Under the Curve in K2 EDTA | Prognosis | No MACE/ACM (*Censored) with TnI value > cutoff | 226 participants |
| Area Under the Curve in Lithium Heparin Separator | Prognosis | MACE/ACM with Troponin value > cutoff | 31 participants |
| Area Under the Curve in Lithium Heparin Separator | Prognosis | No MACE/ACM (*Censored) with TnI value </= cutoff | 791 participants |
| Area Under the Curve in Lithium Heparin Separator | Prognosis | MACE/ACM with Troponin value </= cutoff | 30 participants |
| Area Under the Curve in Lithium Heparin Separator | Prognosis | No MACE/ACM (*Censored) with TnI value > cutoff | 212 participants |
| Area Under the Curve in Serum Separator | Prognosis | No MACE/ACM (*Censored) with TnI value > cutoff | 246 participants |
| Area Under the Curve in Serum Separator | Prognosis | MACE/ACM with Troponin value > cutoff | 19 participants |
| Area Under the Curve in Serum Separator | Prognosis | No MACE/ACM (*Censored) with TnI value </= cutoff | 803 participants |
| Area Under the Curve in Serum Separator | Prognosis | MACE/ACM with Troponin value </= cutoff | 17 participants |
| 90-day Prognosis for Lithium Heparin Separator Tube Type | Prognosis | MACE/ACM with Troponin value </= cutoff | 30 participants |
| 90-day Prognosis for Lithium Heparin Separator Tube Type | Prognosis | No MACE/ACM (*Censored) with TnI value > cutoff | 231 participants |
| 90-day Prognosis for Lithium Heparin Separator Tube Type | Prognosis | No MACE/ACM (*Censored) with TnI value </= cutoff | 790 participants |
| 90-day Prognosis for Lithium Heparin Separator Tube Type | Prognosis | MACE/ACM with Troponin value > cutoff | 34 participants |
| 30-day Prognosis for Serum Separator Tube Type | Prognosis | MACE/ACM with Troponin value > cutoff | 13 participants |
| 30-day Prognosis for Serum Separator Tube Type | Prognosis | No MACE/ACM (*Censored) with TnI value > cutoff | 201 participants |
| 30-day Prognosis for Serum Separator Tube Type | Prognosis | No MACE/ACM (*Censored) with TnI value </= cutoff | 796 participants |
| 30-day Prognosis for Serum Separator Tube Type | Prognosis | MACE/ACM with Troponin value </= cutoff | 17 participants |
| 90-day Prognosis for Serum Separator Tube Type | Prognosis | No MACE/ACM (*Censored) with TnI value </= cutoff | 784 participants |
| 90-day Prognosis for Serum Separator Tube Type | Prognosis | MACE/ACM with Troponin value > cutoff | 26 participants |
| 90-day Prognosis for Serum Separator Tube Type | Prognosis | No MACE/ACM (*Censored) with TnI value > cutoff | 188 participants |
| 90-day Prognosis for Serum Separator Tube Type | Prognosis | MACE/ACM with Troponin value </= cutoff | 29 participants |
Comparison: Kaplan-Meierp-value: 0.0004Log Rank
Comparison: Kaplan-Meierp-value: 0.0004Log Rank
Comparison: Hazard Ratiop-value: 0.001195% CI: [1.59, 5.95]Regression, Cox
Comparison: Kaplan-Meierp-value: <0.0001Log Rank
Comparison: Kaplan-Meierp-value: <0.0001Log Rank
Comparison: Hazard Ratiop-value: <0.000195% CI: [2.21, 6.05]Regression, Cox
Comparison: Kaplan-Meierp-value: <0.0001Log Rank
Comparison: Kaplan-Meierp-value: <0.0001Log Rank
Comparison: Hazard Ratiop-value: 0.000295% CI: [1.84, 6.87]Regression, Cox
Comparison: Kaplan-Meierp-value: <0.0001Log Rank
Comparison: Kaplan-Meierp-value: <0.0001Log Rank
Comparison: Hazard Ratiop-value: <0.000195% CI: [2.25, 6.05]Regression, Cox
Comparison: Kaplan-Meierp-value: 0.002Log Rank
Comparison: Kaplan-Meierp-value: 0.002Log Rank
Comparison: Hazard Ratiop-value: 0.00595% CI: [1.41, 6.05]Regression, Cox
Comparison: Kaplan-Meierp-value: <0.0001Log Rank
Comparison: Kaplan-Meierp-value: <0.0001Log Rank
Comparison: Hazard Ratiop-value: <0.000195% CI: [2.08, 6.03]Regression, Cox