Plain English Summary
Background and study aims
Chest pain can be caused by a variety of conditions, some of them dangerous (such as a heart attack), others harmless (such as a muscle pain). The aim of the study is to show if a new marker (a protein measured in the blood ) Copeptin, may be helpful in quickly identifying patients at higher risk for having a heart attack, thus enabling quick introduction of adequate treatment.
Who can participate?
Adult experiencing chest pain lasting five minutes or more within the last 6 hours.
What does the study involve?
Copeptin is measured for all participants via a blood test on admission to hospital. They then undergo routine treatment according to current guidelines and standards of care. Participants' follow-up data are collected and analyzed in regard to Copeptin concentrations.
What are the possible benefits and risks of participating?
The marker is measured from a blood sample which is taken at the same time as a standard blood test, so does not need additional puncture if the vein. Thus, the risk for participation in the study is minimal.
Where is the study run from?
2nd Department of Cardiology, Medical University of Silesia (Poland)
When is the study starting and how long is it expected to run for?
December 2011 to December 2018
Who is funding the study?
Silesian Medical University (Poland)
Who is the main contact?
Miss Beata Morawiec
Trial website
Contact information
Type
Scientific
Primary contact
Miss Beata Morawiec
ORCID ID
http://orcid.org/0000-0002-0187-1364
Contact details
2nd Department of Cardiology
Medical University of Silesia
M. Sklodowskiej-Curie Str. 10
Zabrze
41-800
Poland
+48322711010
beamorawiec@wp.pl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
COPeptin for diagnosis and prediction in acute coronary syndrome (COPACS) study: design and objectives
Acronym
COPACS - COPeptin for Acute Coronary Syndrome
Study hypothesis
Copeptin, the C-terminal part of prohormone for vasopressin, is a marker of acute endogenous stress. An immediate increase in concentration after a few minutes from the onset of chest pain and rapid peak of concentration (1-2h) have practical implications for chest pain patients. Together with cardiac troponin, which is a specific marker for myocardial injury, it could be effective in quickly identifying patients at higher risk for having a heart attack, thus enabling quick introduction of adequate treatment. The aim of this study is to see whether this is the case.
Ethics approval
Ethical Committee of Medical University of Silesia, 06/12/2011, ref: KNW/0022/KB1/187/11
Study design
Prospective, observational single-center study
Primary study design
Observational
Secondary study design
Case series
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Chest pain
Intervention
Copeptin is measured in patients with chest pain lasting up to 6h at admission and remains double-blinded throughout the enrollment. Further all patients undergo routine management for the condition being the cause of admission, according to current guidelines and standards of care. Patients' follow-up data are collected and analyzed in regard to copeptin concentrations.
Intervention type
Phase
Drug names
Primary outcome measure
1. Primary diagnostic endpoint is the final diagnosis of NSTEMI
2. Primary prognostic endpoint is death of cardiovascular origin
Secondary outcome measures
1. Secondary diagnostic endpoint is the diagnosis of ACS (NSTEMI+UA)
2. Secondary prognostic endpoints is as Major Adverse Cardiac and Cerebrovascular Events (MACCE) and included death of cardiovascular origin, non-fatal AMI, UA, repeated cardiac revascularization, stroke
Overall trial start date
15/12/2011
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Chest pain lasting five minutes or more
2. Beginning of symptoms in last six hours before admission
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
192 per first round of recruitment; up to 500 at the end of recruitment.
Participant exclusion criteria
1. ST-segment elevation myocardial infarction (STEMI)
2. End-stage renal insufficiency (defined as GFR <15 ml/min/1.73m2 and/or dialysis)
3. Anemia (defined as level of hemoglobin <10 g/dl for men; <8 g/dl for women)
4. Hyponatremia (defined as level of Na+ <125mmol/l)
5. Injury or big surgery in last four weeks
6. Cancer with predicted life duration < six months
7. Pregnancy
8. Age < 18 years
9. Lack of informed consent
Recruitment start date
15/12/2011
Recruitment end date
31/12/2016
Locations
Countries of recruitment
Poland
Trial participating centre
2nd Department of Cardiology, Medical University of Silesia
M. Sklodowskiej-Curie Str. 10
Zabrze
41-800
Poland
Funders
Funder type
University/education
Funder name
Silesian Medical University (Poland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
First publication is planned to cover the design and objectives of the study and to be published in an international journal soon. Further plans to be confirmed at a later date.
Intention to publish date
Participant level data
Stored in repository
Basic results (scientific)
Publication list