hsTnT in Patients Admitted to the ED With Atrial Fibrilla... | NCT03344237

Studies
hsTnT in Patients Admitted to the ED With Atrial Fibrillation in the Era of NOACs - Heidelberg Registry of Atrial Fibrillation

NCT03344237

Sponsor

University Hospital Heidelberg

Status

Unknown status

Last Update Posted

Sep 27, 2019Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Not provided

Countries

Germany

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

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 14, 2017Actual

Primary Completion Date

Nov 1, 2019Estimated

Completion Date

Mar 2020Estimated

First Submitted Date

Nov 11, 2017

First Submission Date that Met QC Criteria

Nov 11, 2017

First Posted Date

Nov 17, 2017Actual

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

Sep 26, 2019

Last Update Posted Date

Sep 27, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr.med. Dr.med.univ. Mehrshad VAFAIE, Cardiologist, University Hospital HeidelbergPrincipal Investigator

Lead Sponsor

University Hospital HeidelbergOTHER

Collaborators

Not provided

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

The purpose of the Heidelberg Registry of Atrial Fibrillation (HERA-FIB) is to collect data on the prevalence and clinical significance of elevated cardiac troponin in a large registry of unselected patients with atrial fibrillation presenting to an emergency department in the era of novel oral anticoagulants (NOACs).

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

5,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vascular and non-vascular death		Follow up after at least 6 months
Nonfatal myocardial infarction		Follow up after at least 6 months
Stroke/systemic embolism		Follow up after at least 6 months

Secondary Outcomes

Measure	Description	Time Frame
Stroke, systemic embolism, myocardial infarction, vascular death, non-vascular death, composite endpoint of vascular and non-vascular death, nonfatal MI, stroke/systemic embolism		Follow up after at least 6 months

Other Outcomes

Measure	Description	Time Frame
Major bleeding by definition of International Society on Thrombosis and Haemostasis (ISTH)		Follow up after at least 6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

documented atrial fibrillation
availability of at least one hsTnT measurement

Exclusion Criteria:

none

Accepts Healthy Volunteers

Not provided

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

A cohort of approximately 5000 consecutive patients with atrial fibrillation presenting to the emergency department of the Heidelberg University Hospital between March 2013 and June 2017

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mehrshad Vafaie, Dr.med.Dr.med.univ.	Contact	00496221/56-8676		mehrshad.vafaie@med.uni-heidelberg.de

Overall Officials

Name	Affiliation	Role
Mehrshad Vafaie, Dr.med.Dr.med.univ.	University Hospital Heidelberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiology, Angiology and Pneumology, Heidelberg University Hospital	Recruiting	Heidelberg	Baden-Wurttemberg	69120	Germany

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided