Middle East African Registry Women CardioVascular Disease | NCT05869214

Studies
Middle East African Registry Women CardioVascular Disease

NCT05869214

Sponsor

Tunisian Society of Cardiology and Cardiovascular Surgery

Status

Unknown status

Last Update Posted

May 22, 2023Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Heart Failure
Atrial Fibrillation
Valvular Heart Disease
Ischemic Heart Disease

Interventions

Not provided

Countries

Tunisia

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

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 10, 2023Actual

Primary Completion Date

Jul 10, 2023Estimated

Completion Date

Jul 10, 2023Estimated

First Submitted Date

May 11, 2023

First Submission Date that Met QC Criteria

May 11, 2023

First Posted Date

May 22, 2023Actual

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 11, 2023

Last Update Posted Date

May 22, 2023Actual

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 MEA cardiology societies have joined forces to tackle the issue by establishing a tangible real-world data registry in every MEA country. This endeavor has resulted in the development of a multicenter registry called MEA-WCVD, which is being sponsored by each national cardiology society from participating countries. All data gathered will be consolidated into a singular registry for thorough analysis. Country specific analysis will be performed.

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

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiovascular diseases care management in women will be compared to men in MEA countries according to current practice guidelines		2 months

Secondary Outcomes

Measure	Description	Time Frame
Identify inequalities between both genders in terms of: • Healthcare insurance • Incomes • Access to healthcare		2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All incomers in Cardiovascular (CV) diseases in hospital or out hospital facilities with one of the 4 diagnosis (Heart Failure (HF), Atrial fibrillation (AF), Valvular Heart disease (VHD), ischemic heart disease (IHD)
Age over 18 years old
Men and Women
Signature of consent form

Exclusion Criteria:

Patients with diseases other than the 4 previously mentioned in inclusion criteria

Accepts Healthy Volunteers

Not provided

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

All patients having their consultation in the study participating site.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Salem Abdessalem, Dr	Contact			salem.abdesselem@gmail.com
Selma Charfeddine, Dr	Contact			selma_charfeddine@yahoo.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hedi chaker Hospital	Recruiting	Sfax			Tunisia

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
D006333	Heart Failure
D001281	Atrial Fibrillation
D006349	Heart Valve Diseases
D017202	Myocardial Ischemia

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided