Evaluation of a New Cardiac Biomarker Assay

NCT01608100 | Completed Phase 3 Results

• 1 other identifier: 7B5-02-10A01-03
• Study Type: interventional
• Target: 1,101
• Locations: 1 country
• Sites: 12

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.

Conditions

Acute Coronary Syndrome; Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (5)

• 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).

  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).

  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).

  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).

  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).

  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

  30-day and 90-day follow-up

Study Arms (1)

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.

Device: ARCHITECT STAT High Sensitive Troponin I Assay

Interventions

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.

ARCHITECT STAT High Sensitive Troponin I Assay testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Diagnostics Division: lead

Study Sites (12)

Chandler Regional Medical Center

Chandler, Arizona, 85224, United States

Location

Stanford University School of Emergency Medicine

Palo Alto, California, 94304, United States

Location

Nationwide Laboratory Services

Fort Lauderdale, Florida, 33309, United States

Location

John T Mather Memorial Hospital

Port Jefferson, New York, 11777, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Pennsylvania State University- Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Hospital Physicians in Clinical Research

Austin, Texas, 78752, United States

Location

Hospital Physicians in Clinical Research

Bryan, Texas, 77802, United States

Location

Dept of Emergency Medicine University of Virginia

Charlottesville, Virginia, 22908-2877, United States

Location

St Joseph Hospital

Bellingham, Washington, 98225, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Karla Grasso, Clinical Research Manager
• Organization: Abbott Diagnostics Division

karla.grasso@abbott.com

1 224-667-5602

Study Officials

• Fred S Apple, PhD

  Hennepin Healthcare Research Institute

  PRINCIPAL INVESTIGATOR

• Frank Peacock, MD

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2012
• First Posted: May 30, 2012
• Study Start: June 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 17, 2015
• Results First Posted: March 17, 2015

Record last verified: 2015-01

Locations

US (12)