Investigation of the Biomarker Copeptin in Patients With Acute Myocardial Infarction

Acute Coronary Syndromes Clinical Trial

— CHOPIN  

Official title:

Copeptin Helps in the Early Detection Of Patients With Acute Myocardial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00952744
• Other study ID #: CHOPIN
• Status: Completed
• Phase: N/A
• First received: July 20, 2009
• Last updated: January 16, 2012
• Start date: August 2009
• Est. completion date: October 2011

Study information

• Verified date: January 2012
• Source: Brahms AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2071
• Est. completion date: October 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Myocardial Infarction

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	The Cleveland Clinic	Cleveland	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Stanford University Hospital	Palo Alto	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Virginia Commonwealth University	Richmond	Virginia
United States	University of California, San Diego	San Diego	California
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Brahms AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		at initial presentation, at 2 hours, at 6 hours	No
Secondary	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.		within 180 days after enrollment	No