Condition category
Circulatory System
Date applied
29/07/2015
Date assigned
09/08/2015
Last edited
10/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 measures

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

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

Sponsor information

Organisation

Silesian Medical University

Sponsor details

Poniatowskiego Str 15
Katowice
40-055
Poland

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes