Minor Troponin Elevations in Patients With Atrial Fibrill... | NCT03683836

Studies
Minor Troponin Elevations in Patients With Atrial Fibrillation

NCT03683836

Sponsor

University of Turku

Status

Completed

Last Update Posted

May 8, 2024Actual

Enrollment

3,394Actual

Phase

Not provided

Conditions

Atrial Fibrillation
Myocardial Ischemia

Interventions

No 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

May 2024

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

Jun 1, 2016Actual

Primary Completion Date

Oct 30, 2023Actual

Completion Date

Oct 30, 2023Actual

First Submitted Date

Sep 22, 2018

First Submission Date that Met QC Criteria

Sep 22, 2018

First Posted Date

Sep 25, 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

May 7, 2024

Last Update Posted Date

May 8, 2024Actual

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

This study aims at identifying the etiology of troponin-T elevations in patients with atrial fibrillation visiting the emergency department.

Detailed Description

The aim of this study is to identify the factors associated with minor cardiac troponin-T elevations in patients presenting in emergency department (ED) with atrial fibrillation (AF) diagnosis , and the possible implications it has on the patients prognosis. Data on 3394 patients from the Turku university hospital catchment area with diagnosis of AF on admission to ED and minor troponin-T elevation were analyzed. Patients were classified into three groups according to the troponin-T value: troponin <15ng/l, 15-50ng/l and 51-100ng/l. Individual patient records were reviewed.

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

3,394Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group			Diagnostic Test: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Diagnostic Test	No intervention	Study Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause mortality, myocardial infarction, ischemic stroke	Major adverse cardiac or cerebrovascular event within one year	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

two troponin T tests within 72 hours of ED admission
Prior diagnosis of AF or AF at admission

Exclusion Criteria:

Age < 18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with atrial fibrillation admitted to Turku University Hospital emergency department

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation
D017202	Myocardial Ischemia

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided