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

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ClinicalTrials.gov Identifier: NCT03627455
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : August 14, 2018
Sponsor:
Collaborator:
Association for the Promotion of Research in Atherosclerosis, Thrombosis and Vascular Biology
Information provided by (Responsible Party):
Maximilian Tscharre, MD, Wilhelminenspital Vienna

Brief 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).


Condition or disease Intervention/treatment
Coronary Artery Disease Diabetes Mellitus Other: Percutaneous coronary intervention

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Study Type : Observational
Actual Enrollment : 818 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 1, 2003
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Group/Cohort Intervention/treatment
Male, with DM Other: Percutaneous coronary intervention
Percutaneous coronary intervention

Male, without DM Other: Percutaneous coronary intervention
Percutaneous coronary intervention

Female, with DM Other: Percutaneous coronary intervention
Percutaneous coronary intervention

Female, without DM Other: Percutaneous coronary intervention
Percutaneous coronary intervention




Primary Outcome Measures :
  1. MACE [ Time Frame: 8 years ]
    All-cause death, non-fatal myocardial infarction, non-fatal stroke



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patients undergoing percutaneous coronary intervention at the department of cardiology at the Wihelminenspital
Criteria

Inclusion Criteria:

  • Percutaneous coronary intervention

Exclusion Criteria:

  • unsuccessful percutaneous coronary intervention
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Responsible Party: Maximilian Tscharre, MD, Principal Investigator, Wilhelminenspital Vienna
ClinicalTrials.gov Identifier: NCT03627455    
Other Study ID Numbers: TROPDM2GENDER
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases