Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARCHITECT STAT High Sensitive Troponin I Assay testing | Experimental | All subjects will have their blood tested by the investigational ARCHITECT STAT High SensitiveTroponin I assay. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARCHITECT STAT High Sensitive Troponin I Assay | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fred S Apple, PhD | Hennepin Healthcare Research Institute | Principal Investigator |
| Frank Peacock, MD | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chandler Regional Medical Center | Chandler | Arizona | 85224 | United States | ||
| Stanford University School of Emergency Medicine |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ARCHITECT STAT High Sensitive Troponin I Assay Testing | All subjects will have their blood tested by the investigational Troponin I assay. 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 time frames (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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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). | 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. |
| 30-day and 90-day follow-up |
| Palo Alto |
| California |
| 94304 |
| United States |
| Nationwide Laboratory Services | Fort Lauderdale | Florida | 33309 | United States |
| John T Mather Memorial Hospital | Port Jefferson | New York | 11777 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Pennsylvania State University- Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104-4283 | United States |
| Hospital Physicians in Clinical Research | Austin | Texas | 78752 | United States |
| Hospital Physicians in Clinical Research | Bryan | Texas | 77802 | United States |
| Dept of Emergency Medicine University of Virginia | Charlottesville | Virginia | 22908-2877 | United States |
| St Joseph Hospital | Bellingham | Washington | 98225 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Observed Myocardial Infarction Prevalence | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Number | 95% Confidence Interval | Probability | 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 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | participants | 30-day and 90-day follow-up |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Number | 95% Confidence Interval | percentage MI withTnI >cutoff vs all MI | 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Number | 95% Confidence Interval | % nonMI with TnI </= cutoff vs all nonMI | 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. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Number | 95% Confidence Interval | %nonMI,TnI</=cutoff vs all TnI</=cutoff | 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. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Number | 95% Confidence Interval | %MI,TnI >cutoff vs all TnI > cutoff | 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. |
|
Duration of subject emergency department visit: 24 hours.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ARCHITECT STAT High Sensitive Troponin I Assay Testing | All subjects will have their blood tested by the investigational Troponin I assay. 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 with a troponin result for risk of ACM/MACE in the time frames (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. | 0 | 1,101 | 0 | 1,101 |
Not provided
Not provided
Some tube types and some time points may not have been obtained for each subject. Every attempt was made to collect all tube types within the time point windows described.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karla Grasso, Clinical Research Manager | Abbott Diagnostics Division | 1 224-667-5602 | karla.grasso@abbott.com |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| Hispanic |
|
| Asian |
|
| Other |
|
| Area Under the Curve: 2-4 hours |
|
| Area Under the Curve: 4-9 hours |
|
| Area Under the Curve |
| 0.9431 |
| 2-Sided |
| 95 |
| 0.9081 |
| 0.9782 |
| No |
| Superiority or Other |
| Time point: 4-9 hours | Area Under the Curve | 0.9503 | 2-Sided | 95 | 0.9419 | 0.9857 | No | Superiority or Other |
| Time point: 0-2 hours | Area Under the Curve | 0.9197 | 2-Sided | 95 | 0.8914 | 0.9480 | No | Superiority or Other |
| Time point: 2-4 hours | Area Under the Curve | 0.9349 | 2-Sided | 95 | 0.8986 | 0.9712 | No | Superiority or Other |
| Time point: 4-9 hours | Area Under the Curve | 0.9498 | 2-Sided | 95 | 0.9190 | 0.9805 | No | Superiority or Other |
| Time point: 0-2 hours | Area Under the Curve | 0.9412 | 2-Sided | 95 | 0.9102 | 0.9722 | No | Superiority or Other |
| Time point: 2-4 hours | Area Under the Curve | 0.9419 | 2-Sided | 95 | 0.9041 | 0.9796 | No | Superiority or Other |
| Time point: 4-9 hours | Area Under the Curve | 0.9449 | 2-Sided | 95 | 0.9046 | 0.9852 | No | Superiority or Other |
The 90-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated. |
| OG002 | 30-day Prognosis for Lithium Heparin Separator Tube Type | The 30-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated. |
| OG003 | 90-day Prognosis for Lithium Heparin Separator Tube Type | The 90-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated. |
| OG004 | 30-day Prognosis for Serum Separator Tube Type | The 30-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated. |
| OG005 | 90-day Prognosis for Serum Separator Tube Type | The 90-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated. |
|
|
|
| OG002 | Sensitivity in Serum Separator | Sensitivity for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL). |
|
|
|
| OG002 | Specificity in Serum Separator | Specificity for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL). |
|
|
|
| OG002 | Negative Predictive Value in Serum Separator | Negative Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff 26.2 pg/mL). |
|
|
|
| OG002 | Positive Predictive Value in Serum Separator | Positive Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL). |
|
|
|