Incidence of Paroxysmal Atrial Fibrillation (AF) in Patie... | NCT04679987

Status Module

Record Verification Date

Dec 2020

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

Mar 1, 2019Actual

Primary Completion Date

Oct 1, 2019Actual

Completion Date

Dec 1, 2020Actual

First Submitted Date

Dec 17, 2020

First Submission Date that Met QC Criteria

Dec 17, 2020

First Posted Date

Dec 22, 2020Actual

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

Dec 24, 2020

Last Update Posted Date

Dec 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed Badr Salem, Head of Critical care and emergency medicine, Helwan UniversityPrincipal Investigator

Lead Sponsor

Helwan UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

200 patients presenting with symptoms of acute ischemic stroke or transient ischemic attack were included. All patients free of AF on presentation underwent 48 hours Holter monitoring within one week.

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

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
paroxysmal Af			Diagnostic Test: Holter ECG
no paroxysmal Af			Diagnostic Test: Holter ECG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Holter ECG	Diagnostic Test	all patients will be monitored for paroxysmal Af by holder ECG	no paroxysmal Af paroxysmal Af

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
presence of paroxysmal Af	incidence of paroxysmal Af after TIA	March 2019 -November 2020

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient with acute ischemic stroke or TIAs (within one week of onset)

Exclusion Criteria:

history of persistent AF
initial ECG is AF
primary hemorrhagic stroke
acute large vessel dissection
inability or refusal of consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients diagnosed as acute stroke or TIA in stroke unit and neurology outpatient clinic, neurology Department, faculty of medicine, Misr University for Science and Technology (MUST) University

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Mohamed Badr		Cairo		11461	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D002546	Ischemic Attack, Transient
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D002545	Brain Ischemia
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D004562	Electrocardiography
D006334	Heart Function Tests
D003935	Diagnostic Techniques, Cardiovascular
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D004568	Electrodiagnosis
D018670	Monitoring, Ambulatory
D008991	Monitoring, Physiologic