Chest PainCOPACSNCT01962506
Diagnostic Utility of Copeptin in Addition to High-sensitivity Cardiac Troponin for the Early Diagnosis of NSTE-ACS
An observational study of Chest Pain, run by G. d'Annunzio University at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the Emergency Department.
Who may be able to join
- Chest pain duration > 5 minutes at rest or upon minimal exertion
- Chest pain onset < 6 hours
- Non-traumatic chest pain
Who cannot join
- Cardiac arrest
- STEMI
- New left bundle branch block
Trial locations and contacts
1 site in 1 country.
Fabrizio Ricci contact
Italy1 site, 1 recruiting
- Recruiting
Ospedale Clinicizzato SS. Annunziata
Chieti, Chieti, 66100
About this study
Official title: Diagnostic Utility of Copeptin in Addition to High-sensitivity Cardiac Troponin for the Early Diagnosis of Non-ST-Elevation Acute Coronary Syndromes - The COPACS Study
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.
Read the detailed description
The evaluation of chest pain patients in the emergency department remains a costly and difficult challenge, because a large proportion of them do not suffer from an acute coronary syndrome (ACS). The adequate ruling out of ACS in patients with chest pain is crucial, as the erroneous discharge of a patient with ACS is associated with a high risk of cardiac events. Rapid assessment of these patients is critical to direct further diagnostic and therapeutic strategies. Electrocardiography (ECG) and cardiac troponin (cTn) are the current diagnostic cornerstones and complement clinical assessment in current AMI guidelines1. They allow to rule in an acute myocardial infarction (AMI) within the first 3 hours after presentation in the majority of patients and offer the opportunity to initiate appropriate, evidence-based treatment. The vast majority of patients presenting to the Emergency Department (ED) with suspected AMI, however, finally prove not to have AMI. The current process of ruling out AMI is time-consuming and expensive. One fourth to one-third of patients with AMI present without significant ECG changes indicative of acute ischemia; therefore, the ECG is of little help to rule out AMI, especially in the setting of non-ST elevation ACS (NSTE-ACS). High-sensitivity (hs)-cTn assays have been developed recently, enabling measurements of concentrations that are ∼10-fold lower than those previously measurable. Recent studies have confirmed the increased accuracy of these high-sensitivity assays compared with conventional assays in the early detection of AMI and in the safely ruling in or out of coronary causes of chest pain. However, concerns have been raised about a possible specificity deficit with these new assays. In addition, a second measurement of hs-cTn may be warranted in order to increase the accuracy of the assay.
Copeptin, the C-terminal part of the vasopressin pro-hormone, and a marker of acute endogenous stress, has been demonstrated to be useful for a more rapid ruling out of acute myocardial infarction. Current evidence for the diagnostic validity and performance of a combination of high sensitivity-cardiac troponin and copeptin is limited and controversial. A Bayesian probabilistic approach is likely to be the correct way to evaluate the possible incremental value of copeptin in the detection of ACS. Thus, we aim at prospectively evaluating the diagnostic accuracy of copeptin, hs-cTn, CK-MB and myoglobin, alone or in combination with hs-cTn, for the early diagnosis and ruling out of Non-ST-Elevation (NSTE) ACS versus non-cardiac causes of chest pain in a selected cohort of Emergency Department (ED) chest pain patients according to their pre-test probability, as assessed through a combination of two validated clinical risk score systems (i.e. Chest Pain Score and TIMI Risk Score).
- Conditions
- Chest Pain
- Keywords
- Chest pain, Copeptin, High-sensitivity cardiac troponin, Non-ST-Elevation (NSTE) - ACS
- Medical subject headings
- Chest Pain, Diabetes Insipidus
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: On admission to the Emergency Department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrizio Ricci, MD, G. d'Annunzio University
- Investigators
- Fabrizio Ricci, Principal investigator, Institute of Cardiology and Center of Excellence on Aging, "G. D'Annunzio" University, Chieti, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962506
- Sponsor's protocol ID
- COPACS13
- Acronym
- COPACS
- Status last verified
- Oct 2013
- First submitted
- 10 Oct 2013
- Last updated
- 14 Oct 2013
- Results posted
- No
Publications
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.
PubMed 26169889
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Utility of Copeptin in Addition to High-sensitivity Cardiac Troponin for the Early Diagnosis of Non-ST-Elevation Acute Coronary Syndromes - The COPACS Study
- ClinicalTrials.gov ID
- NCT01962506
- Acronym / sponsor ID
- COPACS / COPACS13
- Conditions
- Chest Pain
- Keywords
- Chest pain, Copeptin, High-sensitivity cardiac troponin, Non-ST-Elevation (NSTE) - ACS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The evaluation of chest pain patients in the emergency department remains a costly and difficult challenge, because a large proportion of them do not suffer from an acute coronary syndrome (ACS). The adequate ruling out of ACS in patients with chest pain is crucial, as the erroneous discharge of a patient with ACS is associated with a high risk of cardiac events. Rapid assessment of these patients is critical to direct further diagnostic and therapeutic strategies. Electrocardiography (ECG) and cardiac troponin (cTn) are the current diagnostic cornerstones and complement clinical assessment in current AMI guidelines1. They allow to rule in an acute myocardial infarction (AMI) within the first 3 hours after presentation in the majority of patients and offer the opportunity to initiate appropriate, evidence-based treatment. The vast majority of patients presenting to the Emergency Department (ED) with suspected AMI, however, finally prove not to have AMI. The current process of ruling out AMI is time-consuming and expensive. One fourth to one-third of patients with AMI present without significant ECG changes indicative of acute ischemia; therefore, the ECG is of little help to rule out AMI, especially in the setting of non-ST elevation ACS (NSTE-ACS). High-sensitivity (hs)-cTn assays have been developed recently, enabling measurements of concentrations that are ∼10-fold lower than those previously measurable. Recent studies have confirmed the increased accuracy of these high-sensitivity assays compared with conventional assays in the early detection of AMI and in the safely ruling in or out of coronary causes of chest pain. However, concerns have been raised about a possible specificity deficit with these new assays. In addition, a second measurement of hs-cTn may be warranted in order to increase the accuracy of the assay.
Copeptin, the C-terminal part of the vasopressin pro-hormone, and a marker of acute endogenous stress, has been demonstrated to be useful for a more rapid ruling out of acute myocardial infarction. Current evidence for the diagnostic validity and performance of a combination of high sensitivity-cardiac troponin and copeptin is limited and controversial. A Bayesian probabilistic approach is likely to be the correct way to evaluate the possible incremental value of copeptin in the detection of ACS. Thus, we aim at prospectively evaluating the diagnostic accuracy of copeptin, hs-cTn, CK-MB and myoglobin, alone or in combination with hs-cTn, for the early diagnosis and ruling out of Non-ST-Elevation (NSTE) ACS versus non-cardiac causes of chest pain in a selected cohort of Emergency Department (ED) chest pain patients according to their pre-test probability, as assessed through a combination of two validated clinical risk score systems (i.e. Chest Pain Score and TIMI Risk Score).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Emergency Department.
Key inclusion criteria (3 listed)
- Chest pain duration > 5 minutes at rest or upon minimal exertion
- Chest pain onset < 6 hours
- Non-traumatic chest pain
Key exclusion criteria (3 listed)
- Cardiac arrest
- STEMI
- New left bundle branch block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: On admission to 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%).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2013.
- Derived from this study: PubMed 26169889Ricci 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrizio Ricci contact
Fabrizio Ricci principal investigator
Institute of Cardiology and Center of Excellence on Aging, "G. D'Annunzio" University, Chieti, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Pain, run by G. d'Annunzio University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabrizio Ricci (+393661088684), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: On admission to the Emergency Department). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01962506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2013.