Investigation of the Biomarker Copeptin in Patients With Acute Myocardial Infarction (CHOPIN)
This study has been completed.
Sponsor:
Brahms AG
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
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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) |
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 (Adult, Senior) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00952744
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
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:
|
Infarction Myocardial Infarction Acute Coronary Syndrome Ischemia Pathologic Processes |
Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on September 27, 2016