Investigation of the Biomarker Copeptin in Patients With Acute Myocardial Infarction

NCT ID: NCT00952744

Last Updated: 2012-01-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2071 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-10-31

Brief 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.

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.

Conditions

Acute Coronary Syndromes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brahms AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alan S Maisel, MD

Role: PRINCIPAL_INVESTIGATOR

Veteran's Affairs Medical Center San Diego, University of California San Diego

W Frank Peacock, MD

Role: STUDY_CHAIR

The Cleveland Clinic

Christian Mueller, MD

Role: STUDY_CHAIR

University Hospital, Basel, Switzerland

Locations

Stanford University Hospital

Palo Alto, California, United States

University of California, San Diego

San Diego, California, United States

University of California, San Francisco

San Francisco, California, United States

Kansas University Medical Center

Kansas City, Kansas, United States

University of Maryland

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

The Cleveland Clinic

Cleveland, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

References

Shah KS, Marston NA, Mueller C, Neath SX, Christenson RH, McCord J, Nowak RM, Vilke GM, Daniels LB, Hollander JE, Apple FS, Cannon CM, Nagurney J, Schreiber D, deFilippi C, Hogan CJ, Diercks DB, Limkakeng A, Anand IS, Wu AH, Clopton P, Jaffe AS, Peacock WF, Maisel AS. Midregional proadrenomedullin predicts mortality and major adverse cardiac events in patients presenting with chest pain: results from the CHOPIN trial. Acad Emerg Med. 2015 May;22(5):554-63. doi: 10.1111/acem.12649. Epub 2015 Apr 23.

Reference Type: DERIVED

PMID: 25908114 (View on PubMed)

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 AHB, 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):150-160. doi: 10.1016/j.jacc.2013.04.011. Epub 2013 Apr 30.

Reference Type: DERIVED

PMID: 23643595 (View on PubMed)

Other Identifiers

CHOPIN

Identifier Type: -

Identifier Source: org_study_id