Atrial Fibrillation Registry in Jordan | NCT02680483

Studies
Atrial Fibrillation Registry in Jordan

NCT02680483

Sponsor

Jordan Collaborating Cardiology Group

Status

Terminated

Last Update Posted

May 25, 2023Actual

Enrollment

2,000Actual

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Not provided

Countries

Jordan

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 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No interested parties agreed to enroll. Poor enrolling rate. In March 2018, the study was terminated.

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Aug 2017Actual

Completion Date

Mar 2018Actual

First Submitted Date

Feb 8, 2016

First Submission Date that Met QC Criteria

Feb 10, 2016

First Posted Date

Feb 11, 2016Estimated

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 24, 2023

Last Update Posted Date

May 25, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ayman J Hammoudeh, MD, FACC, Co- investigator with Munir Zaqqa, MD, FACC, Jordan Collaborating Cardiology GroupPrincipal Investigator

Lead Sponsor

Jordan Collaborating Cardiology GroupOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Prospective registry of all new comers with Atrial fibrillation

Detailed Description

12 tertiary care centers will enroll all AF comers. Details of baseline clinical, EKG, echo, and lab data will be documented for all patients. Management is according to the physicians discretion. Patients will be followed up for 1 year for clinical endpoints including cardiovascular death, stroke, heart failure, systemic embolization and bleeding.. Anticoagulants and other cardiovascular medications will also be documented.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Actual

Label	Type	Description	Intervention Names
AF cohort		AF consecutive patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of stroke and systemic embolization and cardiovascular death	all ischemic and hemorrhagic strokes and embolization to any arterial bed during follow up period	1 year

Secondary Outcomes

Measure	Description	Time Frame
Number of readmission for atrial fibrillation	readmission for atrial fibrillation related problem other than primary such as palpitations, hypotension, syncope, or near syncope.	1 year
Number of readmission for other cardiovascular events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Admission with atrial fibrillation
developing atrial fibrillation during hospitalization for mon AF reason.
age 18 or more years.
patients welling to participate in the registry.

Exclusion Criteria:

age less than 18 years.
patients not welling to participate.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

All new admissions with atrial fibrillation above the age of 18 or those who develop atrial fibrillation during hospitalization for non AF reason.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Munir Zaqqa, MD FACC	Istishari Hospital	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Istishari hospital		Amman		11954	Jordan

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

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