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NCT03627455 Clinical Trial

Troponin I and T and Adverse Outcomes in Patients With and Without Diabetes Mellitus After Coronary Intervention

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03627455
Other study ID # TROPDM2GENDER
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2003
Est. completion date December 31, 2017

Study information
Verified date August 2018
Source Wilhelminenspital Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 818
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Percutaneous coronary intervention

Exclusion Criteria:

- unsuccessful percutaneous coronary intervention

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Percutaneous coronary intervention
Percutaneous coronary intervention

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Wilhelminenspital Vienna Association for the Promotion of Research in Atherosclerosis, Thrombosis and Vascular Biology

Outcome
Type Measure Description Time frame Safety issue
Primary MACE All-cause death, non-fatal myocardial infarction, non-fatal stroke 8 years
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