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Evaluation of a New Cardiac Biomarker Assay

Primary Purpose

Acute Coronary Syndrome, Acute Myocardial Infarction

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ARCHITECT STAT High Sensitive Troponin I Assay
Sponsored by
Abbott Diagnostics Division
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • presenting to the Emergency Department with symptoms consistent with or suggestive of Acute Coronary Syndrome (ACS) defined as at least 5 minutes of chest pain (or symptoms consistent with myocardial ischemia) up to 6 hours prior to initial evaluation.
  • an Electrocardiogram (ECG) result within 2 hours of presentation for observation of Acute Coronary Syndrome (ACS).
  • greater than 18 years of age.
  • not known to be pregnant.
  • agreement to the follow-up required by the study.

Exclusion Criteria:

  • prior participation in this study.
  • require dialysis for end stage renal disease.
  • history of a previous heart transplant.
  • coexisting disorder associated with limited life expectancy.
  • currently participating in another investigational device or drug study.

Sites / Locations

  • Chandler Regional Medical Center
  • Stanford University School of Emergency Medicine
  • Nationwide Laboratory Services
  • John T Mather Memorial Hospital
  • Duke University Medical Center
  • Cleveland Clinic Foundation
  • Pennsylvania State University- Hershey Medical Center
  • Hospital of the University of Pennsylvania
  • Hospital Physicians in Clinical Research
  • Hospital Physicians in Clinical Research
  • Dept of Emergency Medicine University of Virginia
  • St Joseph Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ARCHITECT STAT High Sensitive Troponin I Assay testing

Arm Description

All subjects will have their blood tested by the investigational ARCHITECT STAT High SensitiveTroponin I assay.

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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).

Secondary Outcome Measures

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.

Full Information

First Posted
May 21, 2012
Last Updated
March 4, 2015
Sponsor
Abbott Diagnostics Division
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1. Study Identification

Unique Protocol Identification Number
NCT01608100
Brief Title
Evaluation of a New Cardiac Biomarker Assay
Official Title
Design Validation Protocol for the Evaluation of ARCHITECT STAT High Sensitive Troponin I Assay
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Diagnostics Division

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of the study is to evaluate the performance and intended use of a new cardiac biomarker test, Troponin I, in an intended use population. Blood specimens will be tested using the new investigational test that detects the level of Troponin I. Results will be compared to the diagnosis of whether or not an acute myocardial infarction (MI) occurred.
Detailed Description
The purpose of the cardiac biomarker Troponin I is to aid in the diagnosis of myocardial infarction.The assay is also intended to assist in the prognosis relative risk to all cause mortality (ACM) and major adverse cardiac events (MACE) consisting of myocardial infarction, revascularization, and cardiac death in patients who present with symptoms suggestive of acute coronary syndrome (ACS) without a diagnosis of myocardial infarction. All specimens were collected under a separate specimen collection protocol (Protocol No, 7B5-02-09A01-01: Clinical Specimen Procurement for Biomarker Evaluation of Suspected ACS). The specimens that will be tested include approximately 8300 specimens collected from 1101 subjects presenting to Emergency Departments with signs and symptoms of Acute Coronary Syndrome and will be provided to the clinical sites performing investigational Troponin I testing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Acute Myocardial Infarction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARCHITECT STAT High Sensitive Troponin I Assay testing
Arm Type
Experimental
Arm Description
All subjects will have their blood tested by the investigational ARCHITECT STAT High SensitiveTroponin I assay.
Intervention Type
Device
Intervention Name(s)
ARCHITECT STAT High Sensitive Troponin I Assay
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical Performance - Area Under the Curve
Description
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
Title
Clinical Performance- Sensitivity
Description
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
Title
Clinical Performance- Specificity
Description
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.
Title
Clinical Performance- Negative Predictive Value (NPV)
Description
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.
Title
Clinical Performance- Positive Predictive Value (PPV)
Description
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.
Secondary Outcome Measure Information:
Title
Prognosis
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: presenting to the Emergency Department with symptoms consistent with or suggestive of Acute Coronary Syndrome (ACS) defined as at least 5 minutes of chest pain (or symptoms consistent with myocardial ischemia) up to 6 hours prior to initial evaluation. an Electrocardiogram (ECG) result within 2 hours of presentation for observation of Acute Coronary Syndrome (ACS). greater than 18 years of age. not known to be pregnant. agreement to the follow-up required by the study. Exclusion Criteria: prior participation in this study. require dialysis for end stage renal disease. history of a previous heart transplant. coexisting disorder associated with limited life expectancy. currently participating in another investigational device or drug study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fred S Apple, PhD
Organizational Affiliation
Hennepin Healthcare Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frank Peacock, MD
Official's Role
Study Chair
Facility Information:
Facility Name
Chandler Regional Medical Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Stanford University School of Emergency Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Nationwide Laboratory Services
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
John T Mather Memorial Hospital
City
Port Jefferson
State/Province
New York
ZIP/Postal Code
11777
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Pennsylvania State University- Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Hospital Physicians in Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78752
Country
United States
Facility Name
Hospital Physicians in Clinical Research
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Dept of Emergency Medicine University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908-2877
Country
United States
Facility Name
St Joseph Hospital
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of a New Cardiac Biomarker Assay

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