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

Status unconfirmed

Conditions studied: Acute Coronary Syndromes

In brief

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.

Key facts

Study ID

NCT00880802

Run by

Nanosphere, Inc.

People needed

1500

Starts

2008-12-01

Expected to finish

2011-03-01

Last updated by the study team

2010-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• University of California, Davis — Davis, California, United States
• University of California San Diego — San Diego, California, United States
• Veterans Affairs Medical Center San Diego — San Diego, California, United States
• Stanford University — Stanford, California, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• The Cleveland Clinic — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• St. Joseph Hospital — Bellingham, Washington, United States
• Unversity of Athens, Attikon — Athens, Greece
• Sant'Andrea Hospital — Rome, Italy
• University Hospital Basel — Basel, Switzerland

Full record on ClinicalTrials.gov

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