Obesity Paradox in Non Valvular Atrial Fibrillation Regar... | NCT03904329

Studies
Obesity Paradox in Non Valvular Atrial Fibrillation Regarding Outcomes: Fact or Fiction

NCT03904329

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Aug 4, 2022Actual

Enrollment

1Estimated

Phase

Not provided

Conditions

Obesity Paradox

Interventions

Oral Anticoagulant

Countries

Egypt

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

Feb 2022

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

Oct 1, 2020Actual

Primary Completion Date

Aug 1, 2023Estimated

Completion Date

Oct 1, 2023Estimated

First Submitted Date

Mar 25, 2019

First Submission Date that Met QC Criteria

Apr 3, 2019

First Posted Date

Apr 5, 2019Actual

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 3, 2022

Last Update Posted Date

Aug 4, 2022Actual

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

Obesity paradox In patient with non valvular atrial fibrillation

Detailed Description

Study role of obesity in outcomes of anticoagulation in patients with non valvular atrial fibrillation

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

1Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Obese Patients with non valvular AF		Obese Patients with non valvular AF using oral anti coagulants	Drug: Oral Anticoagulant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral Anticoagulant	Drug	Oral tablets of anti coagulations either warfare or NOACs	Obese Patients with non valvular AF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between obesity and outcomes in non valvular atrial fibrillation	To study effect of obesity in outcomes of non valvular atrial fibrillation regarding the effect of obesity in the outcome of anticoagulants	Sixth months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients presented with non valvular AF
patients on oral anticoagulant

Exclusion Criteria:

valvular AF
Mental illness
History of cerebrovascular stroke
history of bleeding tendency
history of Chronic renal failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Obese patients with non valvular atrial fibrillation within one year from 1/6/2019 to 31/5/2020 among patients with non valvular in assuit university hospitals

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christen Henan, Ressident	Contact	01201558854		Christenamir@yahoo.com
Mahmmoed Abd e El saAbour, Assissetant professor	Contact	01001202779		M_abd_elsabour@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kristen amir	Recruiting	Asyut		23123	Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D000925	Anticoagulants

Ancestor Terms

ID	Term
D006401	Hematologic Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

Browse Leaves

Not provided

Browse Branches

Not provided