Investigation of the Biomarker Copeptin in Patients With Acute Myocardial Infarction (CHOPIN)
While troponin is not detectable until several hours after an Acute Myocardial Infarction (AMI), copeptin is expected to be elevated very early after an AMI. A combination of both markers for the diagnosis of AMI early after the event is therefore expected to be advantageous.
Acute Coronary Syndromes
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Copeptin Helps in the Early Detection Of Patients With Acute Myocardial|
- Copeptin improves early diagnostic performance for AMI when used in combination with troponin for the initial blood draw in patients presenting to the emergency department with symptoms consistent with acute coronary syndromes. [ Time Frame: at initial presentation, at 2 hours, at 6 hours ] [ Designated as safety issue: No ]
- Copeptin improves AMI diag and is prog for outcome. Risk MACE > for 4th qrt. of MR-proADM than 1st. Copeptin adds to phys. assessment for AMI diag. Copeptin >18 pmol/l distinguishes between AMI and UA or other. Copeptin < 18 pmol/l excludes NSTEMI. [ Time Frame: within 180 days after enrollment ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||August 2009|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
In patients with symptoms suggestive of acute coronary syndrome (ACS) such as chest pain or pressure, shortness of breath, diaphoresis, and nausea, detection of a rise and/or fall of troponin with at least one value above the 99th percentile of the upper reference limit is essential to the diagnosis of acute myocardial infarction (AMI). However, current troponin testing has limitations, including antibody specificity, assay imprecision, lack of standardization and a relatively late increase in the circulating troponin level after the onset of ischemia. Studies have shown a low diagnostic sensitivity of troponins when measured early (<6 hours) after symptom onset. Although there are some more sensitive troponin assays with a coefficient of variation (CV)10% at the 99th percentile of a normal reference population, most troponin assays have an imprecision CV of around 20% at the 99th percentile of the reference population. The early insensitivity of troponin results in an unmet need in the clinical evaluation of patients presenting with suspected ACS and AMI.
Copeptin may improve early AMI diagnostic sensitivity because of a number of unique characteristics.
- Copeptin levels are elevated at presentation in patients with AMI compared to patients with other presentations.
- Copeptin levels are elevated in patients with AMI even when troponin levels were not elevated at the time of initial presentation.
- Thus, a combination of troponin and copeptin levels at presentation may result in a more accurate diagnosis of acute AMI than troponin alone.
- Copeptin levels drop 1 day after an AMI.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00952744
|United States, California|
|Stanford University Hospital|
|Palo Alto, California, United States, 94304|
|University of California, San Diego|
|San Diego, California, United States, 92103|
|University of California, San Francisco|
|San Francisco, California, United States, 94110|
|United States, Kansas|
|Kansas University Medical Center|
|Kansas City, Kansas, United States, 66160|
|United States, Maryland|
|University of Maryland|
|Baltimore, Maryland, United States, 21201-1595|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202-2689|
|United States, Minnesota|
|Hennepin County Medical Center|
|Minneapolis, Minnesota, United States, 55404|
|United States, Ohio|
|The Cleveland Clinic|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298-0401|
|Principal Investigator:||Alan S Maisel, MD||Veteran's Affairs Medical Center San Diego, University of California San Diego|
|Study Chair:||W Frank Peacock, MD||The Cleveland Clinic|
|Study Chair:||Christian Mueller, MD||University Hospital, Basel, Switzerland|