Investigation of the Biomarker Copeptin in Patients With Acute Myocardial Infarction

NCT00952744 | Completed

• 1 other identifier: CHOPIN
• Study Type: observational
• Target: 2,071
• Locations: 1 country
• Sites: 11

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.

Conditions

Acute Coronary Syndromes

Keywords

acute myocardial infarction; ST-segment elevation myocardial infarction; STEMI; non-ST-segment elevation myocardial infarction; NSTEMI; unstable angina; unstable angina pectoris; UA; UAP

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Brahms AG: lead

Study Sites (11)

Stanford University Hospital

Palo Alto, California, 94304, United States

Location

University of California, San Diego

San Diego, California, 92103, United States

Location

University of California, San Francisco

San Francisco, California, 94110, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Maryland

Baltimore, Maryland, 21201-1595, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202-2689, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55404, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298-0401, United States

Location

Related Publications (2)

• 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.

  PMID: 25908114 DERIVED

• 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.

  PMID: 23643595 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples

MeSH Terms

Conditions

Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Angina, Unstable

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Alan S Maisel, MD

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

  PRINCIPAL INVESTIGATOR

• W Frank Peacock, MD

  The Cleveland Clinic

  STUDY CHAIR

• Christian Mueller, MD

  University Hospital, Basel, Switzerland

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2009
• First Posted: August 6, 2009
• Study Start: August 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2011
• Last Updated: January 18, 2012

Record last verified: 2012-01

Locations

US (11)