Skip to main content
OpenTrials
Completed

NCT Number: NCT01608100

Evaluation of a New Cardiac Biomarker Assay

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Coronary Syndrome Acute Myocardial Infarction Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chandler Regional Medical Center, Chandler, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

Secondary outcomes

  1. Prognosis

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

    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.

Sponsors and collaborators

Lead sponsor

Abbott Diagnostics Division

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 30, 2012
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.