Evaluation of a New Cardiac Biomarker Assay

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Diagnostics Division
ClinicalTrials.gov Identifier:
NCT01608100
First received: May 21, 2012
Last updated: March 4, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome
Acute Myocardial Infarction
Device: ARCHITECT STAT High Sensitive Troponin I Assay
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Design Validation Protocol for the Evaluation of ARCHITECT STAT High Sensitive Troponin I Assay

Resource links provided by NLM:


Further study details as provided by Abbott Diagnostics Division:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30-day and 90-day follow-up ] [ Designated as safety issue: No ]
    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.


Enrollment: 1101
Study Start Date: June 2012
Study Completion Date: September 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARCHITECT STAT High Sensitive Troponin I Assay testing
All subjects will have their blood tested by the investigational ARCHITECT STAT High SensitiveTroponin I assay.
Device: ARCHITECT STAT High Sensitive Troponin I Assay

Test blood samples from the ARCHITECT STAT High Sensitive Troponin I Assay. Results obtained will be used to assess the prognosis of subjects for risk of ACM/MACE in the timeframes (30 days and 90 days) after the Emergency Department visit.

Troponin results will be compared to documented ACM/MACE events at the 30 day and 90 day time points after Emergency Department visit.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608100

Locations
United States, Arizona
Chandler Regional Medical Center
Chandler, Arizona, United States, 85224
United States, California
Stanford University School of Emergency Medicine
Palo Alto, California, United States, 94304
United States, Florida
Nationwide Laboratory Services
Fort Lauderdale, Florida, United States, 33309
United States, New York
John T Mather Memorial Hospital
Port Jefferson, New York, United States, 11777
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Pennsylvania State University- Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Texas
Hospital Physicians in Clinical Research
Austin, Texas, United States, 78752
Hospital Physicians in Clinical Research
Bryan, Texas, United States, 77802
United States, Virginia
Dept of Emergency Medicine University of Virginia
Charlottesville, Virginia, United States, 22908-2877
United States, Washington
St Joseph Hospital
Bellingham, Washington, United States, 98225
Sponsors and Collaborators
Abbott Diagnostics Division
Investigators
Principal Investigator: Fred S Apple, PhD Minneapolis Medical Research Foundation
Study Chair: Frank Peacock, MD
  More Information

No publications provided

Responsible Party: Abbott Diagnostics Division
ClinicalTrials.gov Identifier: NCT01608100     History of Changes
Other Study ID Numbers: 7B5-02-10A01-03
Study First Received: May 21, 2012
Results First Received: December 3, 2014
Last Updated: March 4, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Infarction
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on September 03, 2015