Acute Coronary SyndromeNCT00953251
TnThs Predicting Evolving Non-STEMI
An observational study of Acute Coronary Syndrome, run by Heidelberg University at 1 site in Germany.
Trial summary
BACKGROUND: We sought to determine the diagnostic value of the new TnThs assay for early detection of evolving non-STEMI in patients with acute coronary syndrome and a negative 4th generation cTnT result on admission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 115 participants
- Where
- 1 siteGermany
- Study dates
- May 2008to Dec 2008
- 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: Between May 2008 and December 2008, 115 consecutive patients were enrolled with symptoms suggestive of ACS. All patients received a 12-lead electrocardiogram recording on admission, and a second 12-lead ECG after 6 hours. Blood samples were collected on admission and ideally every hour within the initial 6 hours after admission.
Who may be able to join
- 115 consecutive patients were enrolled with symptoms suggestive of ACS, admitted to the Chest Pain Unit of the University of Heidelberg. All patients received a 12-lead electrocardiogram (ECG) recording on admission, and a second 12-lead ECG after 6 hours
Who cannot join
- Patients who underwent percutaneous coronary intervention (PCI) during follow-up sampling were excluded as were patients with a significant kidney dysfunction defined as an estimated glomerular filtration rate below 60 ml/min/1.73m2.
- Patients with STEMI were excluded.
- Patients with only 1 blood sample were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Sensitive Cardiac Troponin T for Early Prediction of Evolving Non-ST Segment Elevation Myocardial Infarction in Patients With Suspected Acute Coronary Syndrome and Negative Troponin Result on Admission
BACKGROUND: We sought to determine the diagnostic value of the new TnThs assay for early detection of evolving non-STEMI in patients with acute coronary syndrome and a negative 4th generation cTnT result on admission.
METHODS: We evaluated several statistical patterns of blood results of TnT hs and cTnT of 115 patients and calculated necessity of prediction of evolving non-STEMI within 6 hours.
Read more
RESULTS: Based on the results of the 4th generation cTnT assay, an evolving non-STEMI was diagnosed in 26 patients, 31 were classified as unstable angina. The TnThs lead to an increase of non-STEMI diagnosis as compared to the 4th generation assay. We could calculate increased sensitivities for earlier detection of evolving non-STEMI from 61.5% on admission to 90.9% within 3 hours and 100% within 6 hours compared to cTnT.
CONCLUSIONS: The TnThs assay enables earlier detection of non-STEMI and allows identification of an additional percentage of cases with non-STEMI previously classified as unstable angina.
- Conditions
- Acute Coronary Syndrome
- Keywords
- high sensitive troponin T; non-STEMI; early detection., To detect non-STEMI in a cohort of patients with acute coronary syndrome
- Medical subject headings
- Acute Coronary Syndrome, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with acute coronary syndrome | patients with acute coronary syndrome | |
| Non-STEMI and unstable angina | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine the diagnostic accuracy of the new TnThs in subsequent blood draws for earlier detection of evolving non-STEMI in a nonselected population of patients presenting with ischemic symptoms suggestive of ACS.
Measured: within 6 hours after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startMay 2008
- Primary completionDec 2008
- Study completionDec 2008
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 Coronary SyndromeStudies 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
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953251
- Sponsor's protocol ID
- TnT hs 2
- Status last verified
- Aug 2009
- First submitted
- 5 Aug 2009
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Giannitsis E, Kehayova T, Vafaie M, Katus HA. Combined testing of high-sensitivity troponin T and copeptin on presentation at prespecified cutoffs improves rapid rule-out of non-ST-segment elevation myocardial infarction. Clin Chem. 2011 Oct;57(10):1452-5. doi: 10.1373/clinchem.2010.161265. Epub 2011 Aug 1.
PubMed 21807867
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Sensitive Cardiac Troponin T for Early Prediction of Evolving Non-ST Segment Elevation Myocardial Infarction in Patients With Suspected Acute Coronary Syndrome and Negative Troponin Result on Admission
- ClinicalTrials.gov ID
- NCT00953251
- Acronym / sponsor ID
- TnT hs 2
- Conditions
- Acute Coronary Syndrome
- Keywords
- high sensitive troponin T; non-STEMI; early detection., To detect non-STEMI in a cohort of patients with acute coronary syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 6 Aug 2009 (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.
BACKGROUND: We sought to determine the diagnostic value of the new TnThs assay for early detection of evolving non-STEMI in patients with acute coronary syndrome and a negative 4th generation cTnT result on admission.
METHODS: We evaluated several statistical patterns of blood results of TnT hs and cTnT of 115 patients and calculated necessity of prediction of evolving non-STEMI within 6 hours.
RESULTS: Based on the results of the 4th generation cTnT assay, an evolving non-STEMI was diagnosed in 26 patients, 31 were classified as unstable angina. The TnThs lead to an increase of non-STEMI diagnosis as compared to the 4th generation assay. We could calculate increased sensitivities for earlier detection of evolving non-STEMI from 61.5% on admission to 90.9% within 3 hours and 100% within 6 hours compared to cTnT.
CONCLUSIONS: The TnThs assay enables earlier detection of non-STEMI and allows identification of an additional percentage of cases with non-STEMI previously classified as unstable angina.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with acute coronary syndrome | – | –patients with acute coronary syndrome |
| Non-STEMI and unstable angina | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Between May 2008 and December 2008, 115 consecutive patients were enrolled with symptoms suggestive of ACS. All patients received a 12-lead electrocardiogram recording on admission, and a second 12-lead ECG after 6 hours. Blood samples were collected on admission and ideally every hour within the initial 6 hours after admission.
Key inclusion criteria (1 listed)
- 115 consecutive patients were enrolled with symptoms suggestive of ACS, admitted to the Chest Pain Unit of the University of Heidelberg. All patients received a 12-lead electrocardiogram (ECG) recording on admission, and a second 12-lead ECG after 6 hours
Key exclusion criteria (3 listed)
- Patients who underwent percutaneous coronary intervention (PCI) during follow-up sampling were excluded as were patients with a significant kidney dysfunction defined as an estimated glomerular filtration rate below 60 ml/min/1.73m2.
- Patients with STEMI were excluded.
- Patients with only 1 blood sample were also excluded.
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
to determine the diagnostic accuracy of the new TnThs in subsequent blood draws for earlier detection of evolving non-STEMI in a nonselected population of patients presenting with ischemic symptoms suggestive of ACS.
Time frame: within 6 hours after admission
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 6 Aug 2009.
- Derived from this study: PubMed 21807867Giannitsis E, Kehayova T, Vafaie M, Katus HA. Combined testing of high-sensitivity troponin T and copeptin on presentation at prespecified cutoffs improves rapid rule-out of non-ST-segment elevation myocardial infarction. Clin Chem. 2011 Oct;57(10):1452-5. doi: 10.1373/clinchem.2010.161265. Epub 2011 Aug 1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronary Syndrome, run by Heidelberg University 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 1 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: finished, as of the sponsor's last update on 6 Aug 2009. 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?
to determine the diagnostic accuracy of the new TnThs in subsequent blood draws for earlier detection of evolving non-STEMI in a nonselected population of patients presenting with ischemic symptoms suggestive of ACS. (time frame: within 6 hours after admission). 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 NCT00953251, 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 6 Aug 2009.