Acute Coronary SyndromePhase 3NCT01608100

Evaluation of a New Cardiac Biomarker Assay

A Phase 3 study testing ARCHITECT STAT High Sensitive Troponin I Assay in people with Acute Coronary Syndrome and Acute Myocardial Infarction, run by Abbott Diagnostics Division at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Coronary Syndrome, Acute Myocardial Infarction
What is being tested?: ARCHITECT STAT High Sensitive Troponin I Assay
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,101 participants
Where: 12 sitesUnited States
Study dates: Jun 2012to Sep 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Hospital Physicians in Clinical Research
Austin, Texas, 78752
St Joseph Hospital
Bellingham, Washington, 98225
Hospital Physicians in Clinical Research
Bryan, Texas, 77802
Chandler Regional Medical Center
Chandler, Arizona, 85224
Dept of Emergency Medicine University of Virginia
Charlottesville, Virginia, 22908-2877
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27710
Nationwide Laboratory Services
Fort Lauderdale, Florida, 33309
Pennsylvania State University- Hershey Medical Center
Hershey, Pennsylvania, 17033
Stanford University School of Emergency Medicine
Palo Alto, California, 94304
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
John T Mather Memorial Hospital
Port Jefferson, New York, 11777

Other trials in United States

About this study

Official title: Design Validation Protocol for the Evaluation of ARCHITECT STAT High Sensitive Troponin I Assay

Read the 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.

Conditions: Acute Coronary Syndrome, Acute Myocardial Infarction
Being tested: ARCHITECT STAT High Sensitive Troponin I Assay
Medical subject headings: Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ARCHITECT STAT High Sensitive Troponin I AssayDevice
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.

Study groups in NCT01608100
Study group	Role	What they receive
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. Receives: Device: ARCHITECT STAT High Sensitive Troponin I Assay

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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 outcomes (1)

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.
Measured: 30-day and 90-day follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Sep 2014

First posted30 May 2012 (estimated)
Study startJun 2012
Primary completionAug 2014
Study completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01608100
Sponsor's protocol ID: 7B5-02-10A01-03
Status last verified: Jan 2015
First submitted: 21 May 2012
Last updated: 17 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Design Validation Protocol for the Evaluation of ARCHITECT STAT High Sensitive Troponin I Assay
ClinicalTrials.gov ID: NCT01608100
Acronym / sponsor ID: 7B5-02-10A01-03
Conditions: Acute Coronary Syndrome, Acute Myocardial Infarction
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,101 participants (actual)
Lead sponsor: Abbott Diagnostics DivisionIndustry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Aug 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 30 May 2012 (estimated)
Results: Posted 17 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ARCHITECT STAT High Sensitive Troponin I Assay testing	Experimental	Device: ARCHITECT STAT High Sensitive Troponin I AssayAll subjects will have their blood tested by the investigational ARCHITECT STAT High SensitiveTroponin I assay.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ARCHITECT STAT High Sensitive Troponin I AssayTest 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.	Device	ARCHITECT STAT High Sensitive Troponin I Assay testing

Primary outcome

Clinical Performance - Area Under the Curve
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
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
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
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
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.
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)
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.
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)
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.
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).

1 secondary outcome

Prognosis
Time frame: 30-day and 90-day follow-up

Results and safety

Results posted to the registry on 17 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ARCHITECT STAT High Sensitive Troponin I Assay Testing	1,101	1,101

Primary outcome: Clinical Performance - Area Under the Curve

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. Number (95% Confidence Interval). Unit: Probability

Measure	Area Under the Curve in K2 EDTA n = 1066	Area Under the Curve in Lithium Heparin Separator n = 1088	Area Under the Curve in Serum Separator n = 1029
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)

Area Under the Curve in K2 EDTA: Area Under the Curve: 0.9326 (95% CI 0.9048 to 0.9604)
Area Under the Curve in K2 EDTA: Area Under the Curve: 0.9431 (95% CI 0.9081 to 0.9782)
Area Under the Curve in K2 EDTA: Area Under the Curve: 0.9503 (95% CI 0.9419 to 0.9857)

Population analysed: 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.

Primary outcome: Clinical Performance- Sensitivity

Measure	Sensitivity in K2 EDTA n = 1066	Sensitivity in Lithium Heparin Separator n = 1088	Sensitivity in Serum Separator n = 1029
% 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)

Sensitivity in K2 EDTA: Percent Sensitivity: 84.44 (95% CI 75.28 to 91.23)
Sensitivity in K2 EDTA: Percent Sensitivity: 92.21 (83.81% CI 83.81 to 97.09)
Sensitivity in K2 EDTA: Percent Sensitivity: 93.90 (95% CI 86.34 to 97.99)

Primary outcome: Clinical Performance- Specificity

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.. Number (95% Confidence Interval). Unit: % nonMI with TnI </= cutoff vs all nonMI

Measure	Specificity in K2 EDTA n = 1066	Specificity in Lithium Heparin Separator n = 1088	Specificity in Serum Separator n = 1029
% 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)

Specificity in K2 EDTA: Percent Specificity: 85.73 (95% CI 83.18 to 88.03)
Specificity in K2 EDTA: Percent Specificity: 85.20 (95% CI 82.66 to 87.50)
Specificity in K2 EDTA: Percent Specificity: 82.82 (95% CI 79.99 to 85.40)

Primary outcome: Clinical Performance- Negative Predictive Value (NPV)

Measure	Negative Predictive Value in K2 EDTA n = 1066	Negative Predictive Value in Lithium Heparin Separator n = 1088	Negative Predictive Value in Serum Separator n = 1029
% 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)

Negative Predictive Value in K2 EDTA: Negative Predictive Value: 98.10 (95% CI 96.82 to 98.95)
Negative Predictive Value in K2 EDTA: Negative Predictive Value: 99.19 (95% CI 98.25 to 99.70)
Negative Predictive Value in K2 EDTA: Negative Predictive Value: 99.23 (95% CI 98.22 to 99.75)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Duration of subject emergency department visit: 24 hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ARCHITECT STAT High Sensitive Troponin I Assay Testing	0 of 1,101 (0%)	0 of 1,101 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fred S Apple, PhD principal investigator

Hennepin Healthcare Research Institute

Frank Peacock, MD study chair

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Performance - Area Under the Curve (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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01608100.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.