Troponin I and T and Adverse Outcomes in Patients With an... | NCT03627455

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

NCT03627455

Sponsor

Wilhelminenspital Vienna

Status

Completed

Last Update Posted

Aug 14, 2018Actual

Enrollment

818Actual

Phase

Not provided

Conditions

Coronary Artery Disease
Diabetes Mellitus

Interventions

Percutaneous coronary intervention

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2003Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Dec 31, 2017Actual

First Submitted Date

Aug 8, 2018

First Submission Date that Met QC Criteria

Aug 10, 2018

First Posted Date

Aug 13, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2018

Last Update Posted Date

Aug 14, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maximilian Tscharre, MD, Principal Investigator, Wilhelminenspital ViennaPrincipal Investigator

Lead Sponsor

Wilhelminenspital ViennaOTHER

Collaborators

Name	Class
Association for the Promotion of Research in Atherosclerosis, Thrombosis and Vascular Biology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

818Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Percutaneous coronary intervention	Other	Percutaneous coronary intervention	Female, with DM Female, without DM Male, with DM Male, without DM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MACE	All-cause death, non-fatal myocardial infarction, non-fatal stroke	8 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Percutaneous coronary intervention

Exclusion Criteria:

unsuccessful percutaneous coronary intervention

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D062645	Percutaneous Coronary Intervention

Ancestor Terms

ID	Term
D057510	Endovascular Procedures
D014656	Vascular Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided