Acute Myocardial InfarctionproCORENCT02490969
Copeptin Registry (proCORE) Biomarkers in Cardiology (BIC)-19
An observational study of Acute Myocardial Infarction, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Registry of an interventional Study-proved Strategy (BIC-8) using Copeptin and Troponin for the Early Rule-Out of Acute Myocardial Infarction (AMI) in Patients with Suspected Acute Coronary Syndrome (ACS) and a low-to intermediate risk profile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Routine management observation
- Type of treatment
- Surgery or procedure
- How many people
- 2,256 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2015to 23 May 2017
- How long will I take part?
- 28 Days
- 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: Adult men and women who present to an ED/CPU with signs and symptoms suggestive of acute coronary syndrome (NSTE-ACS) and an intermediate-to low risk profile in whom an early rule-out strategy for AMI is applied and who therefore undergo single combined troponin and copeptin testing at admission as part of standard management.
Who may be able to join
- Admission to the Emergency Department or CPU with signs and symptoms consistent with acute coronary syndrome
- Low-to intermediate risk profile (GRACE-score below 140 and a low- to intermediate likelihood of ACS as judged by the treating physician)
- Patients eligible for the early rule-out strategy using combined copeptin and troponin testing at admission, irrespective of biomarker test results and disposition decision
- full-aged patient
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Registry of an interventional Study-proved Strategy (BIC-8) using Copeptin and Troponin for the Early Rule-Out of Acute Myocardial Infarction (AMI) in Patients with Suspected Acute Coronary Syndrome (ACS) and a low-to intermediate risk profile.
Read the detailed description
Registry of an interventional Study-proved Strategy (BIC-8) using Copeptin and Troponin for the Early Rule-Out of Acute Myocardial Infarction (AMI) in Patients with Suspected Acute Coronary Syndrome (ACS) and a low-to intermediate risk profile.
Primary objective:
To monitor the safety of the early rule-out strategy using combined testing of copeptin and troponin at admission of patients with signs and symptoms suggestive of ACS and a low- to intermediate risk profile, who are discharged or moved to another hospital after testing copeptin and troponin negative (defined as copeptin below 10 pmol/l and cardiac troponin below 99th percentile URL).
Secondary objectives:
- To monitor routine application of the early rule-out strategy, patient characteristics, risk profile of all patients tested for copeptin and troponin at admission, irrespective of their biomarker test result
- To monitor diagnoses, clinical course and outcome of all patients tested for copeptin and troponin at admission
- Conditions
- Acute Myocardial Infarction
- Being tested
- Routine management observation
- Keywords
- copeptin, rule out marker, emergency department, cheast pain unit, emergency department, chest pain unit
- Medical subject headings
- Diabetes Insipidus, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine management observationProcedure or surgery
Early rule out of myocardial infarction with combined copetine and troponin testing at admission
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
One-month all-cause mortality in patients in whom acute myocardial infarction is ruled-out using the early rule-out strategy and who are therefore discharged from the ED
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startSep 2015
- Primary completion23 May 2017
- Study completion23 May 2017
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 Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,256 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Moeckel, Charite University, Berlin, Germany
- Investigators
- Martin Moeckel, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490969
- Sponsor's protocol ID
- BIC 19
- Acronym
- proCORE
- Status last verified
- May 2017
- First submitted
- 25 Jun 2015
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Data will be shared on reasonable request
Publications
Giannitsis E, Clifford P, Slagman A, Ruedelstein R, Liebetrau C, Hamm C, Honnart D, Huber K, Vollert JO, Simonelli C, Schroder M, Wiemer JC, Mueller-Hennessen M, Schroer H, Kastner K, Mockel M. Multicentre cross-sectional observational registry to monitor the safety of early discharge after rule-out of acute myocardial infarction by copeptin and troponin: the Pro-Core registry. BMJ Open. 2019 Jul 23;9(7):e028311. doi: 10.1136/bmjopen-2018-028311.
PubMed 31340965
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copeptin Registry (proCORE) Biomarkers in Cardiology (BIC)-19
- ClinicalTrials.gov ID
- NCT02490969
- Acronym / sponsor ID
- proCORE / BIC 19
- Conditions
- Acute Myocardial Infarction
- Keywords
- copeptin, rule out marker, emergency department, cheast pain unit, emergency department, chest pain unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,256 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 23 May 2017 (actual)
- Study completion
- 23 May 2017 (actual)
- First posted
- 7 Jul 2015 (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.
Registry of an interventional Study-proved Strategy (BIC-8) using Copeptin and Troponin for the Early Rule-Out of Acute Myocardial Infarction (AMI) in Patients with Suspected Acute Coronary Syndrome (ACS) and a low-to intermediate risk profile.
Detailed description
Registry of an interventional Study-proved Strategy (BIC-8) using Copeptin and Troponin for the Early Rule-Out of Acute Myocardial Infarction (AMI) in Patients with Suspected Acute Coronary Syndrome (ACS) and a low-to intermediate risk profile.
Primary objective:
To monitor the safety of the early rule-out strategy using combined testing of copeptin and troponin at admission of patients with signs and symptoms suggestive of ACS and a low- to intermediate risk profile, who are discharged or moved to another hospital after testing copeptin and troponin negative (defined as copeptin below 10 pmol/l and cardiac troponin below 99th percentile URL).
Secondary objectives:
- To monitor routine application of the early rule-out strategy, patient characteristics, risk profile of all patients tested for copeptin and troponin at admission, irrespective of their biomarker test result
- To monitor diagnoses, clinical course and outcome of all patients tested for copeptin and troponin at admission
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 28 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult men and women who present to an ED/CPU with signs and symptoms suggestive of acute coronary syndrome (NSTE-ACS) and an intermediate-to low risk profile in whom an early rule-out strategy for AMI is applied and who therefore undergo single combined troponin and copeptin testing at admission as part of standard management.
Key inclusion criteria (4 listed)
- Admission to the Emergency Department or CPU with signs and symptoms consistent with acute coronary syndrome
- Low-to intermediate risk profile (GRACE-score below 140 and a low- to intermediate likelihood of ACS as judged by the treating physician)
- Patients eligible for the early rule-out strategy using combined copeptin and troponin testing at admission, irrespective of biomarker test results and disposition decision
- full-aged patient
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine management observationEarly rule out of myocardial infarction with combined copetine and troponin testing at admission | Procedure or surgery | – |
Primary outcome
All-cause mortality
Time frame: 30 days
One-month all-cause mortality in patients in whom acute myocardial infarction is ruled-out using the early rule-out strategy and who are therefore discharged from the ED
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- Derived from this study: PubMed 31340965Giannitsis E, Clifford P, Slagman A, Ruedelstein R, Liebetrau C, Hamm C, Honnart D, Huber K, Vollert JO, Simonelli C, Schroder M, Wiemer JC, Mueller-Hennessen M, Schroer H, Kastner K, Mockel M. Multicentre cross-sectional observational registry to monitor the safety of early discharge after rule-out of acute myocardial infarction by copeptin and troponin: the Pro-Core registry. BMJ Open. 2019 Jul 23;9(7):e028311. doi: 10.1136/bmjopen-2018-028311.
- Individual participant dataSharing planned: Undecided. Data will be shared on reasonable request
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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.
Martin Moeckel, MD principal investigator
Charite University, Berlin, Germany
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 Acute Myocardial Infarction, run by Charite University, Berlin, Germany at 1 site in Germany.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 24 May 2017. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 30 days). 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 NCT02490969, 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 24 May 2017.