- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02490969
Copeptin Registry (proCORE) Biomarkers in Cardiology (BIC)-19 (proCORE)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Berlin, Germany, 13353
- Charité - Universitätsmedizin Berlin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
30 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Martin Moeckel, MD, Charite University, Berlin, Germany
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIC 19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Myocardial Infarction
-
Henry Ford Health SystemAbiomed Inc.Enrolling by invitationAcute Myocardial Infarction | Cardiogenic Shock | STEMI | NSTEMI - Non-ST Segment Elevation MI | STEMI - ST Elevation Myocardial Infarction | NSTEMI | Acute Myocardial Infarction With ST Elevation | Acute Myocardial Infarction of Right Ventricle (Disorder) | Acute Myocardial Infarction of Left VentricleUnited States
-
Jordan Collaborating Cardiology GroupCardiovascular Academy GroupTerminatedTriggers of Acute Myocardial Infarction | Time of Onset of Acute Myocardial Infarction | Long-term Prognosis After Acute Myocardial InfarctionJordan
-
Recardio, Inc.CompletedAcute Myocardial Infarction | STEMI - ST Elevation Myocardial Infarction | Acute Myocardial IschemiaNetherlands, Hungary, Austria, Poland, Belgium
-
Yuan's General HospitalKaohsiung Veterans General Hospital.; Sin-Lau HospitalUnknownAcute Myocardial Infarction, of Inferolateral Wall | Acute Myocardial Infarction, of Inferoposterior WallTaiwan
-
Medical Center of South ArkansasWithdrawnAcute Coronary Syndrome | Acute ST Segment Elevation Myocardial InfarctionUnited States
-
Aristotle University Of ThessalonikiRecruitingCardiovascular Diseases | Acute Coronary Syndrome | Acute Myocardial Infarction | Metabolic DisturbanceGreece
-
Barts & The London NHS TrustUniversity College, London; Queen Mary University of LondonCompletedAcute Myocardial InfarctionSwitzerland, Denmark, United Kingdom
-
Sheba Medical CenterCompletedNon ST Elevation Myocardial Infarction | Acute Coronary SyndromesIsrael
-
Medstar Health Research InstituteWithdrawnST-elevation Myocardial Infarction | Acute Myocardial InfarctionUnited States
-
Hennepin Healthcare Research InstituteSiemens HealthineersActive, not recruitingAcute Coronary Syndrome | Acute Myocardial InfarctionUnited States
Clinical Trials on Routine management observation
-
First Affiliated Hospital Xi'an Jiaotong UniversityCompleted
-
Peking University First HospitalRecruitingProtocol-based Management and Perioperative Outcomes in Patients With Chronic Antithrombotic TherapyPerioperative Care | Antithrombotic Therapy | Perioperative OutcomesChina
-
Assistance Publique Hopitaux De MarseilleNot yet recruitingHirschsprung's DiseaseFrance
-
Consorzio OncotechClinical Research Technology S.r.l.UnknownMetastatic Breast CancerItaly
-
Research Center BorstelLudwig-Maximilians - University of Munich; "Marius Nasta" Pulmonology InstituteCompleted
-
Shanghai Yueyang Integrated Medicine HospitalRecruitingColorectal CancerChina
-
University of TromsoUniversity Hospital of North Norway; Public Health Sisters in the Tromsø municipalityCompleted
-
Assiut UniversityNot yet recruitingAluminium Phosphide Poisoning
-
University of TurkuSuspendedDiabetes Mellitus, Type 2China
-
University of MinnesotaCompleted