NCT03627455

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
818

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2018

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

15 years

First QC Date

August 8, 2018

Last Update Submit

August 11, 2018

Conditions

Coronary Artery DiseaseDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • MACE

    All-cause death, non-fatal myocardial infarction, non-fatal stroke

    8 years

Study Arms (4)

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

Interventions

Percutaneous coronary interventionOTHER

Percutaneous coronary intervention

Female, with DMFemale, without DMMale, with DMMale, without DM

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients undergoing percutaneous coronary intervention at the department of cardiology at the Wihelminenspital

You may qualify if:

  • Percutaneous coronary intervention

You may not qualify if:

  • unsuccessful percutaneous coronary intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery DiseaseDiabetes Mellitus

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 8, 2018

First Posted

August 13, 2018

Study Start

January 1, 2003

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

August 14, 2018

Record last verified: 2018-08