Copeptin a marker for diagnosis and prognosis in heart attack

• Register: ISRCTN
• Last refreshed on: 18 September 2023
• Main ID: ISRCTN14112941
• Date of registration: 09/08/2015
• Prospective Registration: No
• Primary sponsor: Silesian Medical University
• Public title: Copeptin a marker for diagnosis and prognosis in heart attack
• Scientific title: COPeptin for diagnosis and prediction in acute coronary syndrome (COPACS) study: design and objectives
• Date of first enrolment: 15/12/2011
• Target sample size: 500
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN14112941
• Study type: Observational
• Study design: Prospective, observational single-center study (Diagnostic)
• Phase: Not Applicable

Countries of recruitment

Poland

Contacts

• Name: Beata Morawiec

Key inclusion & exclusion criteria

Inclusion criteria: 1. Chest pain lasting five minutes or more
2. Beginning of symptoms in last six hours before admission
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Chest pain
Circulatory System

Intervention(s)

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.

Primary Outcome(s)

1. Primary diagnostic endpoint is the final diagnosis of NSTEMI
2. Primary prognostic endpoint is death of cardiovascular origin

Secondary Outcome(s)

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

Secondary ID(s)

N/A

Source(s) of Monetary Support

Silesian Medical University (Poland)

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Ethical Committee of Medical University of Silesia, 06/12/2011, ref: KNW/0022/KB1/187/11

Results

• Results available: Yes
• Date Completed: 31/12/2018