Diagnostic Utility of Copeptin in Addition to High-sensitivity Cardiac Troponin for the Early Diagnosis of NSTE-ACS

NCT01962506 | Unknown

• 1 other identifier: COPACS13
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Rapid and reliable exclusion of acute myocardial infarction (AMI) during an emergency department (ED) triage is a major unmet clinical need. We aimed at verifying the non-inferiority of a single-sampling strategy of hs-cTn and copeptin compared with the dual hs-cTn sampling for the early diagnosis of Non-ST-Elevation Acute Coronary Syndromes (NSTE-ACS) versus Non Coronary Chest Pain (NCCP) in a selected cohort of consecutive patients admitted at the Emergency Department.

Conditions

Chest Pain

Keywords

Chest pain; Copeptin; High-sensitivity cardiac troponin; Non-ST-Elevation (NSTE) - ACS

Outcome Measures

Primary Outcomes (1)

• Non-inferiority of a single-sampling strategy of hs-cTn and copeptin compared with the dual hs-cTn sampling for the early diagnosis of NSTE-ACS in a selected cohort of consecutive patients admitted at the Emergency Department.

  We aimed at verifying the hypothesis that diagnostic efficiency of the combination of copeptin and hs-cTn on admission would be non-inferior with respect to the 3 hours interval hs-cTn serial sampling for the early diagnosis or ruling out of NSTE-ACS versus non cardiac chest pain in a selected cohort of consecutive ED chest pain patients. According to current international guidelines we selected a 20% difference between serial hscTn levels to establish the diagnosis of myocardial infarction, since the change represented twice the recommended maximum imprecision (a coefficient of variation of 10%).

  On admission to the Emergency Department

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to the Emergency Department.

You may qualify if:

• Chest pain duration \> 5 minutes at rest or upon minimal exertion
• Chest pain onset \< 6 hours
• Non-traumatic chest pain

You may not qualify if:

• Cardiac arrest
• STEMI
• New left bundle branch block

Sponsors & Collaborators

• G. d'Annunzio University: lead

Study Sites (1)

Ospedale Clinicizzato SS. Annunziata

Chieti, Chieti, 66100, Italy

RECRUITING

Related Publications (1)

• Ricci F, Di Scala R, Massacesi C, Di Nicola M, Cremonese G, De Pace D, Rossi S, Griffo I, Cataldo I, Martinotti S, Rotondo D, Jaffe AS, Zimarino M, De Caterina R. Ultra-Sensitive Copeptin and Cardiac Troponin in Diagnosing Non-ST-Segment Elevation Acute Coronary Syndromes--The COPACS Study. Am J Med. 2016 Jan;129(1):105-14. doi: 10.1016/j.amjmed.2015.06.033. Epub 2015 Jul 11.

  PMID: 26169889 DERIVED

MeSH Terms

Conditions

Chest Pain; Diabetes Insipidus

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Fabrizio Ricci

  Institute of Cardiology and Center of Excellence on Aging, "G. D'Annunzio" University, Chieti, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabrizio Ricci

CONTACT

+393661088684

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fabrizio Ricci, MD

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 14, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 14, 2013

Record last verified: 2013-10

Locations

IT (1)