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Acute Coronary SyndromesCHOPINNCT00952744

Investigation of the Biomarker Copeptin in Patients With Acute Myocardial Infarction

An observational study of Acute Coronary Syndromes, run by Brahms AG at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndromes
How many people
2,071 participants
Where
11 sitesUnited States
Study dates
Aug 2009to Oct 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.)

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • University of Maryland

    Baltimore, Maryland, 21201-1595

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • The Cleveland Clinic

    Cleveland, Ohio, 44195

  • Henry Ford Hospital

    Detroit, Michigan, 48202-2689

  • Kansas University Medical Center

    Kansas City, Kansas, 66160

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55404

  • Stanford University Hospital

    Palo Alto, California, 94304

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4283

  • Virginia Commonwealth University

    Richmond, Virginia, 23298-0401

  • University of California, San Diego

    San Diego, California, 92103

  • University of California, San Francisco

    San Francisco, California, 94110

Other trials in United States

About this study

Official title: 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.

Read the 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.
Keywords
acute myocardial infarction, ST-segment elevation myocardial infarction, STEMI, non-ST-segment elevation myocardial infarction, NSTEMI, unstable angina, unstable angina pectoris, UA, UAP
Medical subject headings
Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Angina, Unstable

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: at initial presentation, at 2 hours, at 6 hours

Secondary outcomes (1)

  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.

    Measured: within 180 days after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionOct 2010
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,071 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00952744
Sponsor's protocol ID
CHOPIN
Acronym
CHOPIN
Status last verified
Jan 2012
First submitted
20 Jul 2009
Last updated
18 Jan 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25908114

  • 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.

    PubMed 23643595

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndromes, run by Brahms AG at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00952744, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2012.

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