Trial Outcomes & Findings for Evaluation of a New Cardiac Biomarker Assay (NCT NCT01608100)
NCT ID: NCT01608100
Last Updated: 2015-03-17
Results Overview
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).
COMPLETED
PHASE3
1101 participants
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
2015-03-17
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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1101
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Overall Study
COMPLETED
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1101
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of a New Cardiac Biomarker Assay
Baseline characteristics by cohort
| Measure |
ARCHITECT STAT High Sensitive Troponin I Assay Testing
n=1101 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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746 Participants
n=5 Participants
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Age, Categorical
>=65 years
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355 Participants
n=5 Participants
|
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Sex: Female, Male
Female
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482 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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619 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Black
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300 participants
n=5 Participants
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Race/Ethnicity, Customized
White
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692 participants
n=5 Participants
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Race/Ethnicity, Customized
Hispanic
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62 participants
n=5 Participants
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Race/Ethnicity, Customized
Asian
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18 participants
n=5 Participants
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Race/Ethnicity, Customized
Other
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29 participants
n=5 Participants
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Observed Myocardial Infarction Prevalence
Number Participants with Myocardial Infarction
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130 participants
n=5 Participants
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Observed Myocardial Infarction Prevalence
Number Participants without Myocardial Infarction
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971 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 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 departmentPopulation: 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.
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).
Outcome measures
| Measure |
Area Under the Curve in K2 EDTA
n=1066 Participants
Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
|
Area Under the Curve in Lithium Heparin Separator
n=1088 Participants
Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
|
Area Under the Curve in Serum Separator
n=1029 Participants
Area Under the Curve 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).
|
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.
|
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.
|
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.
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Clinical Performance - Area Under the Curve
Area Under the Curve: 4-9 hours
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0.9503 Probability
Interval 0.9419 to 0.9857
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0.9498 Probability
Interval 0.919 to 0.9805
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0.9449 Probability
Interval 0.9046 to 0.9852
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—
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—
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—
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Clinical Performance - Area Under the Curve
Area Under the Curve: 0-2 hours
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0.9326 Probability
Interval 0.9048 to 0.9604
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0.9197 Probability
Interval 0.8914 to 0.948
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0.9412 Probability
Interval 0.9102 to 0.9722
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—
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—
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—
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Clinical Performance - Area Under the Curve
Area Under the Curve: 2-4 hours
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0.9431 Probability
Interval 0.9081 to 0.9782
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0.9349 Probability
Interval 0.8986 to 0.9712
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0.9419 Probability
Interval 0.9041 to 0.9796
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—
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—
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—
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PRIMARY outcome
Timeframe: 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 departmentPopulation: 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.
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).
Outcome measures
| Measure |
Area Under the Curve in K2 EDTA
n=1066 Participants
Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
|
Area Under the Curve in Lithium Heparin Separator
n=1088 Participants
Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
|
Area Under the Curve in Serum Separator
n=1029 Participants
Area Under the Curve 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).
|
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.
|
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.
|
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.
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Clinical Performance- Sensitivity
% Sensitivity: 0-2 hours
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84.44 percentage MI withTnI >cutoff vs all MI
Interval 75.28 to 91.23
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85.26 percentage MI withTnI >cutoff vs all MI
Interval 76.51 to 91.7
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87.32 percentage MI withTnI >cutoff vs all MI
Interval 77.3 to 94.04
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—
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—
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—
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Clinical Performance- Sensitivity
% Sensitivity: 2-4 hours
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92.21 percentage MI withTnI >cutoff vs all MI
Interval 83.81 to 97.09
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91.86 percentage MI withTnI >cutoff vs all MI
Interval 83.95 to 96.66
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92.00 percentage MI withTnI >cutoff vs all MI
Interval 83.4 to 97.01
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—
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—
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—
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Clinical Performance- Sensitivity
% Sensitivity: 4-9 hours
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93.90 percentage MI withTnI >cutoff vs all MI
Interval 86.34 to 97.99
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94.95 percentage MI withTnI >cutoff vs all MI
Interval 88.61 to 98.34
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93.15 percentage MI withTnI >cutoff vs all MI
Interval 84.74 to 97.74
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—
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—
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—
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PRIMARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Area Under the Curve in K2 EDTA
n=1066 Participants
Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
|
Area Under the Curve in Lithium Heparin Separator
n=1088 Participants
Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
|
Area Under the Curve in Serum Separator
n=1029 Participants
Area Under the Curve 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).
|
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.
|
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.
|
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.
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Clinical Performance- Specificity
% Specificity: 0-2 hours
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85.73 % nonMI with TnI </= cutoff vs all nonMI
Interval 83.18 to 88.03
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83.76 % nonMI with TnI </= cutoff vs all nonMI
Interval 81.12 to 86.17
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86.35 % nonMI with TnI </= cutoff vs all nonMI
Interval 83.79 to 88.63
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—
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—
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—
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Clinical Performance- Specificity
% Specificity: 2-4 hours
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85.20 % nonMI with TnI </= cutoff vs all nonMI
Interval 82.66 to 87.5
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83.72 % nonMI with TnI </= cutoff vs all nonMI
Interval 81.09 to 86.11
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85.81 % nonMI with TnI </= cutoff vs all nonMI
Interval 83.31 to 88.07
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—
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—
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—
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Clinical Performance- Specificity
% Specificity: 4-9 hours
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82.82 % nonMI with TnI </= cutoff vs all nonMI
Interval 79.99 to 85.4
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80.72 % nonMI with TnI </= cutoff vs all nonMI
Interval 77.82 to 83.39
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84.05 % nonMI with TnI </= cutoff vs all nonMI
Interval 81.31 to 86.54
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—
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—
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—
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PRIMARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Area Under the Curve in K2 EDTA
n=1066 Participants
Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
|
Area Under the Curve in Lithium Heparin Separator
n=1088 Participants
Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
|
Area Under the Curve in Serum Separator
n=1029 Participants
Area Under the Curve 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).
|
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.
|
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.
|
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.
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|---|---|---|---|---|---|---|
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Clinical Performance- Negative Predictive Value (NPV)
% NPV: 0-2 hours
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98.10 %nonMI,TnI</=cutoff vs all TnI</=cutoff
Interval 96.82 to 98.95
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98.08 %nonMI,TnI</=cutoff vs all TnI</=cutoff
Interval 96.81 to 98.95
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98.73 %nonMI,TnI</=cutoff vs all TnI</=cutoff
Interval 97.61 to 99.42
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—
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—
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—
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Clinical Performance- Negative Predictive Value (NPV)
% NPV: 2-4 hours
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99.19 %nonMI,TnI</=cutoff vs all TnI</=cutoff
Interval 98.25 to 99.7
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99.05 %nonMI,TnI</=cutoff vs all TnI</=cutoff
Interval 98.05 to 99.62
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99.20 %nonMI,TnI</=cutoff vs all TnI</=cutoff
Interval 98.27 to 99.71
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—
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—
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—
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Clinical Performance- Negative Predictive Value (NPV)
% NPV: 4-9 hours
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99.23 %nonMI,TnI</=cutoff vs all TnI</=cutoff
Interval 98.22 to 99.75
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99.24 %nonMI,TnI</=cutoff vs all TnI</=cutoff
Interval 98.22 to 99.75
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99.25 %nonMI,TnI</=cutoff vs all TnI</=cutoff
Interval 98.26 to 99.76
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—
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—
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—
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PRIMARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Area Under the Curve in K2 EDTA
n=1066 Participants
Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
|
Area Under the Curve in Lithium Heparin Separator
n=1088 Participants
Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
|
Area Under the Curve in Serum Separator
n=1029 Participants
Area Under the Curve 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).
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
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Clinical Performance- Positive Predictive Value (PPV)
% PPV: 0-2 hours
|
38.78 %MI,TnI >cutoff vs all TnI > cutoff
Interval 31.92 to 45.98
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36.82 %MI,TnI >cutoff vs all TnI > cutoff
Interval 30.43 to 43.56
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35.84 %MI,TnI >cutoff vs all TnI > cutoff
Interval 28.7 to 43.47
|
—
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—
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—
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Clinical Performance- Positive Predictive Value (PPV)
% PPV: 2-4 hours
|
35.68 %MI,TnI >cutoff vs all TnI > cutoff
Interval 29.03 to 42.76
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35.75 %MI,TnI >cutoff vs all TnI > cutoff
Interval 29.43 to 42.45
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35.94 %MI,TnI >cutoff vs all TnI > cutoff
Interval 29.16 to 43.16
|
—
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—
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—
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Clinical Performance- Positive Predictive Value (PPV)
% PPV: 4-9 hours
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36.49 %MI,TnI >cutoff vs all TnI > cutoff
Interval 29.99 to 43.38
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37.75 %MI,TnI >cutoff vs all TnI > cutoff
Interval 31.71 to 44.09
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35.05 %MI,TnI >cutoff vs all TnI > cutoff
Interval 28.36 to 42.21
|
—
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—
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—
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SECONDARY outcome
Timeframe: 30-day and 90-day follow-upPopulation: 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.
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.
Outcome measures
| Measure |
Area Under the Curve in K2 EDTA
n=1064 Participants
Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
|
Area Under the Curve in Lithium Heparin Separator
n=1064 Participants
Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
|
Area Under the Curve in Serum Separator
n=1085 Participants
Area Under the Curve 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).
|
90-day Prognosis for Lithium Heparin Separator Tube Type
n=1085 Participants
The 90-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
|
30-day Prognosis for Serum Separator Tube Type
n=1027 Participants
The 30-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
|
90-day Prognosis for Serum Separator Tube Type
n=1027 Participants
The 90-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
|
|---|---|---|---|---|---|---|
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Prognosis
MACE/ACM with Troponin value </= cutoff
|
19 participants
|
30 participants
|
17 participants
|
30 participants
|
17 participants
|
29 participants
|
|
Prognosis
No MACE/ACM (*Censored) with TnI value </= cutoff
|
802 participants
|
791 participants
|
803 participants
|
790 participants
|
796 participants
|
784 participants
|
|
Prognosis
MACE/ACM with Troponin value > cutoff
|
17 participants
|
31 participants
|
19 participants
|
34 participants
|
13 participants
|
26 participants
|
|
Prognosis
No MACE/ACM (*Censored) with TnI value > cutoff
|
226 participants
|
212 participants
|
246 participants
|
231 participants
|
201 participants
|
188 participants
|
Adverse Events
ARCHITECT STAT High Sensitive Troponin I Assay Testing
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Karla Grasso, Clinical Research Manager
Abbott Diagnostics Division
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60