Investigation of the Biomarker Copeptin in Patients With Acute Myocardial

Status Completed

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.

Clinical Trial 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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00952744
Study type	Observational
Source	Brahms AG
Contact
Status	Completed
Phase	N/A
Start date	August 2009
Completion date	October 2011

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Investigation of the Biomarker Copeptin in Patients With Acute Myocardial Infarction — CHOPIN

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms