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
  Purpose

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.


Condition
Acute Coronary Syndromes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Copeptin Helps in the Early Detection Of Patients With Acute Myocardial

Resource links provided by NLM:


Further study details as provided by Brahms AG:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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

Plasma samples


Enrollment: 2071
Study Start Date: August 2009
Study Completion Date: October 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00952744

Locations
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
Sponsors and Collaborators
Brahms AG
Investigators
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
  More Information

No publications provided by Brahms AG

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brahms AG
ClinicalTrials.gov Identifier: NCT00952744     History of Changes
Other Study ID Numbers: CHOPIN
Study First Received: July 20, 2009
Last Updated: January 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Brahms AG:
acute myocardial infarction
ST-segment elevation myocardial infarction
STEMI
non-ST-segment elevation myocardial infarction
NSTEMI
unstable angina
unstable angina pectoris
UA
UAP

Additional relevant MeSH terms:
Myocardial Infarction
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014