NCT00880802

Brief Summary

Study Objectives The following items will be prospectively assessed. Primary Endpoints

  1. 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. 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.
  3. 3.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.
  4. 4.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.
  5. 5.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.
  6. 6.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.
  7. 7.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.
  8. 8.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.
  9. 9.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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2008

Typical duration for all trials

Geographic Reach
4 countries

16 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 14, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

January 12, 2010

Status Verified

January 1, 2010

Enrollment Period

2.1 years

First QC Date

April 11, 2009

Last Update Submit

January 8, 2010

Conditions

Acute Coronary Syndromes

Keywords

Acute Coronary SyndromesNon ST-Segment Elevation Myocardial InfarctionST-Segment Elevation Myocardial InfarctionUnstable Angina

Outcome Measures

Primary Outcomes (2)

  • 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.

    30 days after enrollment completion

  • 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.

    30 days, 90 days, 180 days and 1 year after the primary incident

Secondary Outcomes (2)

  • 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.

    30 days after enrollment completion

  • 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.

    30 days after enrollment completion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

University of California, Davis

Davis, California, 95817, United States

Location

University of California San Diego

San Diego, California, 92103, United States

Location

Veterans Affairs Medical Center San Diego

San Diego, California, 92161, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

St. Joseph Hospital

Bellingham, Washington, 98225, United States

Location

Unversity of Athens, Attikon

Athens, 12461, Greece

Location

Sant'Andrea Hospital

Rome, 00189, Italy

Location

University Hospital Basel

Basel, Switzerland

Location

Related Publications (1)

  • Peacock WF, Maisel AS, Mueller C, Anker SD, Apple FS, Christenson RH, Collinson P, Daniels LB, Diercks DB, Somma SD, Filippatos G, Headden G, Hiestand B, Hollander JE, Kaski JC, Kosowsky JM, Nagurney JT, Nowak RM, Schreiber D, Vilke GM, Wayne MA, Than M. Finding acute coronary syndrome with serial troponin testing for rapid assessment of cardiac ischemic symptoms (FAST-TRAC): a study protocol. Clin Exp Emerg Med. 2022 Jun;9(2):140-145. doi: 10.15441/ceem.21.154. Epub 2022 Jun 30.

    PMID: 35843615DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples.

MeSH Terms

Conditions

Acute Coronary SyndromeST Elevation Myocardial InfarctionAngina, Unstable

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesMyocardial InfarctionInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisAngina PectorisChest PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • W. Frank Peacock, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 11, 2009

First Posted

April 14, 2009

Study Start

December 1, 2008

Primary Completion

January 1, 2011

Study Completion

March 1, 2011

Last Updated

January 12, 2010

Record last verified: 2010-01

Locations

GR(1)CH(1)US(13)IT(1)