A Phase 3 interventional study of ARCHITECT STAT High Sensitive Troponin I Assay in Acute Coronary Syndrome and Acute Myocardial Infarction, sponsored by Abbott Diagnostics Division. Completed at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-17.
Sponsored by Abbott Diagnostics Division (part of Abbott) · Phase 3, Interventional, and Diagnostic
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.
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.
1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.
This study's enrollment of 1,101 is above the median of 200 across 865 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Abbott Diagnostics Division is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All subjects will have their blood tested by the investigational ARCHITECT STAT High SensitiveTroponin I assay.
Device: ARCHITECT 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.
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
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
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.
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.
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.
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
| Milestone | ARCHITECT STAT High Sensitive Troponin I Assay Testing |
|---|---|
| Started | 1101 |
| Completed | 1101 |
| Not completed | 0 |
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).
| Probability | Area Under the Curve in K2 EDTA | Area Under the Curve in Lithium Heparin Separator | Area Under the Curve in Serum Separator |
|---|---|---|---|
| Area Under the Curve: 0-2 hours | 0.9326 (0.9048 to 0.9604) | 0.9197 (0.8914 to 0.9480) | 0.9412 (0.9102 to 0.9722) |
| Area Under the Curve: 2-4 hours | 0.9431 (0.9081 to 0.9782) | 0.9349 (0.8986 to 0.9712) | 0.9419 (0.9041 to 0.9796) |
| Area Under the Curve: 4-9 hours | 0.9503 (0.9419 to 0.9857) | 0.9498 (0.9190 to 0.9805) | 0.9449 (0.9046 to 0.9852) |
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.
| participants | 30-day Prognosis for K2 EDTA Tube Type | 90-day Prognosis for K2 EDTA Tube Type | 30-day Prognosis for Lithium Heparin Separator Tube Type | 90-day Prognosis for Lithium Heparin Separator Tube Type | 30-day Prognosis for Serum Separator Tube Type | 90-day Prognosis for Serum Separator Tube Type |
|---|---|---|---|---|---|---|
| MACE/ACM with Troponin value </= cutoff | 19 | 30 | 17 | 30 | 17 | 29 |
| No MACE/ACM (*Censored) with TnI value </= cutoff | 802 | 791 | 803 | 790 | 796 | 784 |
| MACE/ACM with Troponin value > cutoff | 17 | 31 | 19 | 34 | 13 | 26 |
| No MACE/ACM (*Censored) with TnI value > cutoff | 226 | 212 | 246 | 231 | 201 | 188 |
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).
| percentage MI withTnI >cutoff vs all MI | Sensitivity in K2 EDTA | Sensitivity in Lithium Heparin Separator | Sensitivity in Serum Separator |
|---|---|---|---|
| % Sensitivity: 0-2 hours | 84.44 (75.28 to 91.23) | 85.26 (76.51 to 91.70) | 87.32 (77.30 to 94.04) |
| % Sensitivity: 2-4 hours | 92.21 (83.81 to 97.09) | 91.86 (83.95 to 96.66) | 92.00 (83.40 to 97.01) |
| % Sensitivity: 4-9 hours | 93.90 (86.34 to 97.99) | 94.95 (88.61 to 98.34) | 93.15 (84.74 to 97.74) |
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).
| % nonMI with TnI </= cutoff vs all nonMI | Specificity in K2 EDTA | Specificity in Lithium Heparin Separator | Specificity in Serum Separator |
|---|---|---|---|
| % Specificity: 0-2 hours | 85.73 (83.18 to 88.03) | 83.76 (81.12 to 86.17) | 86.35 (83.79 to 88.63) |
| % Specificity: 2-4 hours | 85.20 (82.66 to 87.50) | 83.72 (81.09 to 86.11) | 85.81 (83.31 to 88.07) |
| % Specificity: 4-9 hours | 82.82 (79.99 to 85.40) | 80.72 (77.82 to 83.39) | 84.05 (81.31 to 86.54) |
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).
| %nonMI,TnI</=cutoff vs all TnI</=cutoff | Negative Predictive Value in K2 EDTA | Negative Predictive Value in Lithium Heparin Separator | Negative Predictive Value in Serum Separator |
|---|---|---|---|
| % NPV: 0-2 hours | 98.10 (96.82 to 98.95) | 98.08 (96.81 to 98.95) | 98.73 (97.61 to 99.42) |
| % NPV: 2-4 hours | 99.19 (98.25 to 99.70) | 99.05 (98.05 to 99.62) | 99.20 (98.27 to 99.71) |
| % NPV: 4-9 hours | 99.23 (98.22 to 99.75) | 99.24 (98.22 to 99.75) | 99.25 (98.26 to 99.76) |
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).
| %MI,TnI >cutoff vs all TnI > cutoff | Positive Predictive Value in K2 EDTA | Positive Predictive Value in Lithium Heparin Separator | Positive Predictive Value in Serum Separator |
|---|---|---|---|
| % PPV: 0-2 hours | 38.78 (31.92 to 45.98) | 36.82 (30.43 to 43.56) | 35.84 (28.70 to 43.47) |
| % PPV: 2-4 hours | 35.68 (29.03 to 42.76) | 35.75 (29.43 to 42.45) | 35.94 (29.16 to 43.16) |
| % PPV: 4-9 hours | 36.49 (29.99 to 43.38) | 37.75 (31.71 to 44.09) | 35.05 (28.36 to 42.21) |
Collected over Duration of subject emergency department visit: 24 hours.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ARCHITECT STAT High Sensitive Troponin I Assay Testing | — | 0/1,101 (0%) | 0/1,101 (0%) |
| Age, Categorical(Participants) | ARCHITECT STAT High Sensitive Troponin I Assay Testing |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 746 |
| >=65 years | 355 |
| Sex: Female, Male(Participants) | ARCHITECT STAT High Sensitive Troponin I Assay Testing |
|---|---|
| Female | 482 |
| Male | 619 |
| Race/Ethnicity, Customized(participants) | ARCHITECT STAT High Sensitive Troponin I Assay Testing |
|---|---|
| Black | 300 |
| White | 692 |
| Hispanic | 62 |
| Asian | 18 |
| Other | 29 |
| Observed Myocardial Infarction Prevalence(participants) | ARCHITECT STAT High Sensitive Troponin I Assay Testing |
|---|---|
| Number Participants with Myocardial Infarction | 130 |
| Number Participants without Myocardial Infarction | 971 |
The record gives a start of Jun 2012, a primary completion of Aug 2014 and a completion of Sep 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2015, 7 months after primary completion.
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This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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