NSTEMI - Non-ST Segment Elevation MIT-infarctionNCT03057093
TIII Over TI in Subjects With Myocardial Infarction
An observational study of NSTEMI - Non-ST Segment Elevation MI, run by University of Cologne.
Trial summary
Study was performed to identify ECG criteria for unmasking of subjects with NSTEMI at elevated risk. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- NSTEMI - Non-ST Segment Elevation MI
- What is being tested?
- Non interventional study
- How many people
- 903 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 15 Jan 2017
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Subjects with acute myocardial infarction without ST segment elevation
Who may be able to join
- NSTEMI and PCI
Who cannot join
- NSTEMI without percutaneous intervention
About this study
Official title: Assessment of T Wave Changes of Patients With Acute Non-ST-elevation Myocardial Infarction
Study was performed to identify ECG criteria for unmasking of subjects with NSTEMI at elevated risk.
Read the detailed description
In the present study the investigators assessed the value of T wave changes in subjects with NSTEMI (TIII>TI).
- Conditions
- NSTEMI - Non-ST Segment Elevation MI
- Being tested
- Non interventional study
- Keywords
- NSTEMI, ECG
- Medical subject headings
- Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventional studyOther
retrospective noninterventional study
| Study group | Role | What they receive |
|---|---|---|
| TIII>TI | Subjects with TIII>TI in initial ECG Receives: Other: Non interventional study | |
| Non TIII>TI | Subjects without TIII>TI in initial ECG Receives: Other: Non interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial infarction size
Assessment of myocardial damage using biomarkers
Measured: 5 Days
Secondary outcomes (1)
Correlation with coronary artery
Assessment of association of infarct related artery and ECG changes
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start1 Jan 2011
- Primary completion30 Sep 2013
- Study completion15 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSTEMI - Non-ST Segment Elevation MIStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 903 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Fikret Er, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057093
- Sponsor's protocol ID
- Twave1
- Acronym
- T-infarction
- Status last verified
- Feb 2017
- First submitted
- 15 Feb 2017
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of T Wave Changes of Patients With Acute Non-ST-elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03057093
- Acronym / sponsor ID
- T-infarction / Twave1
- Conditions
- NSTEMI - Non-ST Segment Elevation MI
- Keywords
- NSTEMI, ECG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 903 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 30 Sep 2013 (actual)
- Study completion
- 15 Jan 2017 (actual)
- First posted
- 17 Feb 2017 (actual)
- 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.
Study was performed to identify ECG criteria for unmasking of subjects with NSTEMI at elevated risk.
Detailed description
In the present study the investigators assessed the value of T wave changes in subjects with NSTEMI (TIII>TI).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIII>TI | – | Other: Non interventional studySubjects with TIII>TI in initial ECG |
| Non TIII>TI | – | Other: Non interventional studySubjects without TIII>TI in initial ECG |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with acute myocardial infarction without ST segment elevation
Key inclusion criteria (1 listed)
- NSTEMI and PCI
Key exclusion criteria (1 listed)
- NSTEMI without percutaneous intervention
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 |
|---|---|---|
| Non interventional studyretrospective noninterventional study | Other | Non TIII>TI, TIII>TI |
Primary outcome
Myocardial infarction size
Time frame: 5 Days
Assessment of myocardial damage using biomarkers
1 secondary outcome
Correlation with coronary artery
Time frame: 1 day
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 17 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of NSTEMI - Non-ST Segment Elevation MI, run by University of Cologne.
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 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 17 Feb 2017. 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?
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?
Myocardial infarction size (time frame: 5 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2017.