Coronary Artery DiseaseNCT03627455
Troponin I and T and Adverse Outcomes in Patients With and Without Diabetes Mellitus After Coronary Intervention
An observational study of Coronary Artery Disease and Diabetes Mellitus, run by Wilhelminenspital Vienna.
Trial summary
Elevated levels of troponin are associated with future MACE. Data on the prognostic value of high sensitive troponin T (hs-TnT) as compared to high sensitive troponin I (hs-TnI) in diabetic and non-diabetic patients are sparse. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, Diabetes Mellitus
- What is being tested?
- Percutaneous coronary intervention
- How many people
- 818 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2003to 31 Dec 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients undergoing percutaneous coronary intervention at the department of cardiology at the Wihelminenspital
Who may be able to join
- Percutaneous coronary intervention
Who cannot join
- unsuccessful percutaneous coronary intervention
About this study
Official title: A Sex-specific Analysis of the Predictive Value of Troponin I and T in Patients With and Without Diabetes Mellitus After Successful Coronary Intervention
Elevated levels of troponin are associated with future MACE. Data on the prognostic value of high sensitive troponin T (hs-TnT) as compared to high sensitive troponin I (hs-TnI) in diabetic and non-diabetic patients are sparse.
We aimed to assess the risk for MACE according to gender and diabetes status and to compare the prognostic value of hs-TnT and hs-TnI with regards to clinical outcomes in diabetic and non-diabetic patients undergoing percutaneous coronary intervention (PCI).
- Conditions
- Coronary Artery Disease, Diabetes Mellitus
- Being tested
- Percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionOther
Percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| Male, with DM | Not described Receives: Other: Percutaneous coronary intervention | |
| Male, without DM | Not described Receives: Other: Percutaneous coronary intervention | |
| Female, with DM | Not described Receives: Other: Percutaneous coronary intervention | |
| Female, without DM | Not described Receives: Other: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
All-cause death, non-fatal myocardial infarction, non-fatal stroke
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start1 Jan 2003
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- 818 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wilhelminenspital Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Association for the Promotion of Research in Atherosclerosis, Thrombosis and Vascular Biology
- Responsible party
- Principal investigator, Maximilian Tscharre, MD, Wilhelminenspital Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627455
- Sponsor's protocol ID
- TROPDM2GENDER
- Status last verified
- Aug 2018
- First submitted
- 8 Aug 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sex-specific Analysis of the Predictive Value of Troponin I and T in Patients With and Without Diabetes Mellitus After Successful Coronary Intervention
- ClinicalTrials.gov ID
- NCT03627455
- Acronym / sponsor ID
- TROPDM2GENDER
- Conditions
- Coronary Artery Disease, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 818 participants (actual)
- Lead sponsor
- Wilhelminenspital ViennaUniversity, hospital or other
- Collaborators
- Association for the Promotion of Research in Atherosclerosis, Thrombosis and Vascular Biology
- Study start
- 1 Jan 2003 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 13 Aug 2018 (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.
Elevated levels of troponin are associated with future MACE. Data on the prognostic value of high sensitive troponin T (hs-TnT) as compared to high sensitive troponin I (hs-TnI) in diabetic and non-diabetic patients are sparse.
We aimed to assess the risk for MACE according to gender and diabetes status and to compare the prognostic value of hs-TnT and hs-TnI with regards to clinical outcomes in diabetic and non-diabetic patients undergoing percutaneous coronary intervention (PCI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Male, with DM | – | Other: Percutaneous coronary intervention |
| Male, without DM | – | Other: Percutaneous coronary intervention |
| Female, with DM | – | Other: Percutaneous coronary intervention |
| Female, without DM | – | Other: Percutaneous coronary intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients undergoing percutaneous coronary intervention at the department of cardiology at the Wihelminenspital
Key inclusion criteria (1 listed)
- Percutaneous coronary intervention
Key exclusion criteria (1 listed)
- unsuccessful percutaneous coronary 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 |
|---|---|---|
| Percutaneous coronary interventionPercutaneous coronary intervention | Other | Female, with DM, Female, without DM, Male, with DM, Male, without DM |
Primary outcome
MACE
Time frame: 8 years
All-cause death, non-fatal myocardial infarction, non-fatal stroke
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 14 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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 Coronary Artery Disease and Diabetes Mellitus, run by Wilhelminenspital Vienna.
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 14 Aug 2018. 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?
MACE (time frame: 8 years). 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 14 Aug 2018.