Coronary Artery DiseaseNCT02116153
Mi-RNAs and Specificity of Hs-TnT in Symptomatic ED Patients
An observational study of Coronary Artery Disease and Myocardial Infarction, run by University Hospital Heidelberg.
Trial summary
Biomarkers play a key role in the diagnostic workup of patients presenting to an emergency department (ED). European and American guidelines recommend cardiac Troponin (T or I) as the biomarker gold standard for the diagnosis of non-ST-elevation myocardial infarction (non-STEMI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Infarction
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jun 2014to Dec 2015
- 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 presenting to the emergency department with symptoms suggestive of acute coronary syndrome.
Who may be able to join
- Patients admitted to the emergency department ("chest pain unit"), Dept. of Cardiology, University Hospital Heidelberg
- Symptoms suggestive of ACS incl. chest pain, dyspnea, atypical pain
- Age >= 18 years
- Written informed consent
Who cannot join
- Mental disorders, dementia
- Pregnancy, breast feeding
- Age < 18 years
Trial locations and contacts
No sites are listed yet.
Moritz Biener, MD contact
About this study
Official title: Clinical Use of Mi-RNAs to Improve Specificity of High-sensitivity Troponin T in Symptomatic Patients Presenting to the ED
Biomarkers play a key role in the diagnostic workup of patients presenting to an emergency department (ED). European and American guidelines recommend cardiac Troponin (T or I) as the biomarker gold standard for the diagnosis of non-ST-elevation myocardial infarction (non-STEMI). Today, high-sensitivitiy assays are available and allow an early diagnosis of non-STEMI and the detection of troponin in individuals that would have been classified as unstable angina with former assays. As many patients are detected with elevated troponin values with the high sensitivity assays, specificity for non-STEMI has inevitably decreased. Micro-RNAs (mi-RNA) are new biomarkers with a wide spectrum of detectable conditions that allow specific identification of myocardial infarction. The aim of this study is to develop a biomarker protocol that combines the high sensitivity of cardiac Troponin T and the high specificity of mi-RNA profiles for early and safe identification of non-STEMI in ED patients.
- Conditions
- Coronary Artery Disease, Myocardial Infarction
- Keywords
- Cardiac Troponin T, Micro-RNA, Sensitivity, Specificity
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction, Cardiomyopathy, Familial Restrictive, 3, Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Measured: 90 days
Secondary outcomes (1)
Myocardial Infraction
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015 (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 Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe 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
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Stiftung für Herzforschung
- Responsible party
- Principal investigator, Professor Hugo Katus, University Hospital Heidelberg
- Investigators
- Evangelos Giannitsis, MD, Principal investigator, University Hospital HeidelbergHugo A Katus, MD, Study director, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116153
- Sponsor's protocol ID
- UHHD-BM-003
- Status last verified
- Apr 2014
- First submitted
- 14 Apr 2014
- Last updated
- 16 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Biener M, Giannitsis E, Thum T, Bar C, Costa A, Andrzejewski T, Stoyanov KM, Vafaie M, Meder B, Katus HA, de Gonzalo-Calvo D, Mueller-Hennessen M. Diagnostic value of circulating microRNAs compared to high-sensitivity troponin T for the detection of non-ST-segment elevation myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2021 Aug 24;10(6):653-660. doi: 10.1093/ehjacc/zuaa034.
PubMed 33580779
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Use of Mi-RNAs to Improve Specificity of High-sensitivity Troponin T in Symptomatic Patients Presenting to the ED
- ClinicalTrials.gov ID
- NCT02116153
- Acronym / sponsor ID
- UHHD-BM-003
- Conditions
- Coronary Artery Disease, Myocardial Infarction
- Keywords
- Cardiac Troponin T, Micro-RNA, Sensitivity, Specificity
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Deutsche Stiftung für Herzforschung
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 16 Apr 2014 (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.
Biomarkers play a key role in the diagnostic workup of patients presenting to an emergency department (ED). European and American guidelines recommend cardiac Troponin (T or I) as the biomarker gold standard for the diagnosis of non-ST-elevation myocardial infarction (non-STEMI). Today, high-sensitivitiy assays are available and allow an early diagnosis of non-STEMI and the detection of troponin in individuals that would have been classified as unstable angina with former assays. As many patients are detected with elevated troponin values with the high sensitivity assays, specificity for non-STEMI has inevitably decreased. Micro-RNAs (mi-RNA) are new biomarkers with a wide spectrum of detectable conditions that allow specific identification of myocardial infarction. The aim of this study is to develop a biomarker protocol that combines the high sensitivity of cardiac Troponin T and the high specificity of mi-RNA profiles for early and safe identification of non-STEMI in ED patients.
Study design
- Observational model
- Case only
- 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 presenting to the emergency department with symptoms suggestive of acute coronary syndrome.
Key inclusion criteria (4 listed)
- Patients admitted to the emergency department ("chest pain unit"), Dept. of Cardiology, University Hospital Heidelberg
- Symptoms suggestive of ACS incl. chest pain, dyspnea, atypical pain
- Age >= 18 years
- Written informed consent
Key exclusion criteria (3 listed)
- Mental disorders, dementia
- Pregnancy, breast feeding
- Age < 18 years
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
Death
Time frame: 90 days
1 secondary outcome
Myocardial Infraction
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2014.
- Derived from this study: PubMed 33580779Biener M, Giannitsis E, Thum T, Bar C, Costa A, Andrzejewski T, Stoyanov KM, Vafaie M, Meder B, Katus HA, de Gonzalo-Calvo D, Mueller-Hennessen M. Diagnostic value of circulating microRNAs compared to high-sensitivity troponin T for the detection of non-ST-segment elevation myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2021 Aug 24;10(6):653-660. doi: 10.1093/ehjacc/zuaa034.
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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.
Moritz Biener, MD contact
Evangelos Giannitsis, MD principal investigator
University Hospital Heidelberg
Hugo A Katus, MD study director
University Hospital Heidelberg
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Myocardial Infarction, run by University Hospital Heidelberg.
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 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 16 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
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 Moritz Biener, MD (moritz.biener@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 90 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 NCT02116153, 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 16 Apr 2014.