Finding Acute Coronary Syndromes (ACS) With Serial Troponin Testing for Rapid Assessment of Cardiac Ischemic Symptoms (FAST-TRAC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Nanosphere, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Nanosphere, Inc.
ClinicalTrials.gov Identifier:
NCT00880802
First received: April 11, 2009
Last updated: January 8, 2010
Last verified: January 2010
  Purpose

Study Objectives

The following items will be prospectively assessed.

Primary Endpoints

  1. For patients presenting with clinical suspicion of Acute Coronary Syndromes (ACS), high sensitivity-cardiac Troponin I (hs-cTnI) provides improved diagnostic accuracy for ACS (including Acute Myocardial Infarction (AMI) and/or Unstable Angina (UA)) within the first two (2) hours after emergency department presentation when compared to currently available troponin assays.
  2. For patients presenting with clinical suspicion of ACS, hs-cTnI provides improved prognostic information with regard to 180 day event rates of Major Adverse Cardiac Event outcomes, including cardiac deaths which are defined as all deaths except those that are clearly non-cardiac in nature (e.g. trauma), when compared to a currently available troponin assay.

Secondary Endpoints

  1. For patients presenting with clinical suspicion of ACS, using the rate of rise of hs-cTnI over time between presentation and 2 hours (delta hs-cTnI) allows for the differentiation between ACS and other disease states.
  2. For patients presenting with clinical suspicion of ACS, hs-cTnI provides improved sensitivity for detecting AMI within the first two (2) hours after presentation when compared to a currently available troponin assay.
  3. For patients presenting with clinical suspicion of ACS, hs-cTnI provides improved negative predictive value for ruling out ACS (AMI or UA) within the first 2 hours after presentation when compared to a currently available troponin assay.
  4. For alternative endpoints of cardiac mortality, and for alternative censor time points of 30 days, 90 days, and 1 year, hs-cTnI provides improved prognostic information when compared to the currently available troponin assay.
  5. In cases where the emergency physician has limited diagnostic confidence, hs-cTnI AMI diagnostic accuracy will be superior to local hospital standards for AMI determination.
  6. In cases where the emergency physician has limited diagnostic confidence, the slope for the hs-cTnI between presentation and 2 hours will add diagnostic accuracy for ACS diagnosis over and above local hospital standards for ACS determination.
  7. For patients presenting with clinical suspicion of ACS, the difference in diagnostic accuracy for ACS (including AMI and/or UA) using hs-cTnI measurement from time of onset of symptoms to emergency department presentation (e.g. 3 hours instead of 6 hours) will be evaluated to assess any variation.

Condition
Acute Coronary Syndromes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Finding ACS With Serial Troponin Testing for Rapid Assessment of Cardiac Ischemic Symptoms

Resource links provided by NLM:


Further study details as provided by Nanosphere, Inc.:

Primary Outcome Measures:
  • All enrolled patients will have subject diagnosis (non-ACS, ACS [MI or UA]) assessed utilizing a "Gold Standard" adjudication process. Timing of ACS diagnosis (per cTnI level and change) by hs-cTnI and currently available cTnI assay will be compared. [ Time Frame: 30 days after enrollment completion ] [ Designated as safety issue: No ]
  • All enrolled patients will be followed up at 30, 90 and 180 days, and 1 year. Outcome information that will be assessed includes mortality, cardiac re-hospitalization, cardiac events, and re-vascularization. [ Time Frame: 30 days, 90 days, 180 days and 1 year after the primary incident ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Using the rate of rise of hs-cTnI over time between presentation and 2 hours (delta hs-cTnI), differentiation between ACS and other chronic disorders may be possible. [ Time Frame: 30 days after enrollment completion ] [ Designated as safety issue: No ]
  • Measuring the hs-cTnI level at a given threshold, may provide improved negative predictive value for ruling-out ACS (AMI or UA) within the first 2 hours after presentation. [ Time Frame: 30 days after enrollment completion ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma samples.


Estimated Enrollment: 1500
Study Start Date: December 2008
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This study is designed to evaluate cTnI in heparinized plasma at more frequent intervals than most rapid rule-out or rule-in protocols from ED subjects who: 1) are experiencing signs and symptoms consistent with ACS or ischemic heart disease in the ED, 2) have their initial ECG analysis performed in the ED, and 3) are expected to have cTnI measured serially in the ED.

Criteria

Inclusion Criteria:

  • The subject must be at least 18 years of age or older.
  • The subject must present to the Emergency Department with symptoms consistent with acute coronary syndromes (e.g., chest discomfort/pain, squeezing/fullness in the chest, pain radiating to left or both arms, jaw pain, pain in back/neck/stomach, shortness of breath, cold sweat, nausea/vomiting, lightheadedness).
  • The subject must present to the Emergency Department within six (6) hours of the onset of the most recent symptoms that prompted the subject to seek medical attention in the Emergency Department.
  • The subject agrees to abide by the protocol, including all telephone follow-up.

Exclusion Criteria:

  • The subject is in acute distress and requires immediate life-saving intervention.
  • The subject has experienced CPR, defibrillation, or cardioversion within 24 hours of presentation to the Emergency Department.
  • The subject cannot give consent or understand the informed consent form.
  • The subject has a terminal illness (e.g. metastatic cancer) and is not expected to survive 6 months.
  • Patient has trauma related ACS symptoms (i.e. penetrating wounds, crush injury).
  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: NCT00880802

Locations
United States, California
University of California, Davis
Davis, California, United States, 95817
University of California San Diego
San Diego, California, United States, 92103
Veterans Affairs Medical Center San Diego
San Diego, California, United States, 92161
Stanford University
Stanford, California, United States, 94305
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Washington
St. Joseph Hospital
Bellingham, Washington, United States, 98225
Greece
Unversity of Athens, Attikon
Athens, Greece, 12461
Italy
Sant'Andrea Hospital
Rome, Italy, 00189
Switzerland
University Hospital Basel
Basel, Switzerland
Sponsors and Collaborators
Nanosphere, Inc.
Investigators
Principal Investigator: W. Frank Peacock, MD The Cleveland Clinic
Study Chair: Christian Mueller, MD University Hospital, Basel, Switzerland
Study Chair: Alan S Maisel, MD Veterans Affairs Medical Center San Diego and University of California, San Diego
  More Information

No publications provided

Responsible Party: Greg Shipp, MD / Chief Medical Officer; VP, Medical and Regulatory Affairs, Nanosphere, Inc.
ClinicalTrials.gov Identifier: NCT00880802     History of Changes
Other Study ID Numbers: FAST-TRAC
Study First Received: April 11, 2009
Last Updated: January 8, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Nanosphere, Inc.:
Acute Coronary Syndromes
Non ST-Segment Elevation Myocardial Infarction
ST-Segment Elevation Myocardial Infarction
Unstable Angina

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

ClinicalTrials.gov processed this record on August 26, 2014