Investigation of the Biomarker Copeptin in Patients With Acute Myocardial Infarction (CHOPIN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brahms AG
ClinicalTrials.gov Identifier:
NCT00952744
First received: July 20, 2009
Last updated: January 16, 2012
Last verified: January 2012

July 20, 2009
January 16, 2012
August 2009
October 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00952744 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Investigation of the Biomarker Copeptin in Patients With Acute Myocardial Infarction
Copeptin Helps in the Early Detection Of Patients With Acute Myocardial

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Plasma samples

Probability Sample

Patients presenting to the ED with symptoms consistent with acute coronary syndromes.

Acute Coronary Syndromes
Not Provided
Not Provided
Maisel A, Mueller C, Neath SX, Christenson RH, Morgenthaler NG, McCord J, Nowak RM, Vilke G, Daniels LB, Hollander JE, Apple FS, Cannon C, Nagurney JT, Schreiber D, deFilippi C, Hogan C, Diercks DB, Stein JC, Headden G, Limkakeng AT Jr, Anand I, Wu AH, Papassotiriou J, Hartmann O, Ebmeyer S, Clopton P, Jaffe AS, Peacock WF. Copeptin helps in the early detection of patients with acute myocardial infarction: primary results of the CHOPIN trial (Copeptin Helps in the early detection Of Patients with acute myocardial INfarction). J Am Coll Cardiol. 2013 Jul 9;62(2):150-60. doi: 10.1016/j.jacc.2013.04.011. Epub 2013 Apr 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2071
October 2011
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The subject must be 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 the back/neck/stomach, shortness of breath, cold sweat, nausea/vomiting, lightheadedness).
  • The subject must present to the Emergency Department within 6 hours of the onset of the most recent symptoms that prompted the subject to seek medical attention in the Emergency Department.
  • The patient agrees to abide by all aspects of the protocol, including all telephone follow-up.

Exclusion Criteria:

  • The patient is unable to provide consent or understand the consent form.
  • The ACS symptoms are clearly not the result of ACS (i.e., penetrating wounds, crush injury, etc.)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00952744
CHOPIN
No
Brahms AG
Brahms AG
Not Provided
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
Brahms AG
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP