Copeptin a marker for diagnosis and prognosis in heart attack
| ISRCTN | ISRCTN14112941 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14112941 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/07/2015
- Registration date
- 09/08/2015
- Last edited
- 05/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
2nd Department of Cardiology
Medical University of Silesia
M. Sklodowskiej-Curie Str. 10
Zabrze
41-800
Poland
 ORCID ID |
0000-0002-0187-1364 |
|---|---|
| Phone | +48322711010 |
| beamorawiec@wp.pl |
Study information
| Study design | Prospective, observational single-center study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | COPeptin for diagnosis and prediction in acute coronary syndrome (COPACS) study: design and objectives |
| Study acronym | COPACS - COPeptin for Acute Coronary Syndrome |
| Study objectives | 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(s) | Ethical Committee of Medical University of Silesia, 06/12/2011, ref: KNW/0022/KB1/187/11 |
| Health condition(s) or problem(s) studied | 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 | Other |
| 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 study start date | 15/12/2011 |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 192 per first round of recruitment; up to 500 at the end of recruitment. |
| Total final enrolment | 154 |
| Key inclusion criteria | 1. Chest pain lasting five minutes or more 2. Beginning of symptoms in last six hours before admission |
| Key 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 |
| Date of first enrolment | 15/12/2011 |
| Date of final enrolment | 31/12/2016 |
Locations
Countries of recruitment
- Poland
Study participating centre
Zabrze
41-800
Poland
Sponsor information
University/education
Poniatowskiego Str 15
Katowice
40-055
Poland
"ROR" |
https://ror.org/005k7hp45 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| 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. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 24/01/2018 | 11/12/2020 | Yes | No |
| Other publications | Study design | 17/11/2016 | 05/09/2023 | Yes | No |
| Results article | 12/11/2018 | 05/09/2023 | Yes | No |
Editorial Notes
05/09/2023: Publication references added.
11/12/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
