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

January 16, 2012 updated by: Brahms AG

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

2071

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University Hospital
      • San Diego, California, United States, 92103
        • University of California, San Diego
      • San Francisco, California, United States, 94110
        • University of California, San Francisco
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Kansas University Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201-1595
        • University of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202-2689
        • Henry Ford Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Hennepin County Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • University of Pennsylvania
    • Virginia
      • Richmond, Virginia, United States, 23298-0401
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at initial presentation, at 2 hours, at 6 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
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
within 180 days after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brahms AG

Investigators

  • Study Chair: Christian Mueller, MD, University Hospital, Basel, Switzerland
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

July 20, 2009

First Submitted That Met QC Criteria

August 4, 2009

First Posted (Estimate)

August 6, 2009

Study Record Updates

Last Update Posted (Estimate)

January 18, 2012

Last Update Submitted That Met QC Criteria

January 16, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHOPIN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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