Irisin Expression and Gene Polymorphism With Peripartum C... | NCT04927715

Studies
Irisin Expression and Gene Polymorphism With Peripartum Cardiomyopathy.

NCT04927715

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Jan 19, 2022Actual

Enrollment

45Estimated

Phase

Not provided

Conditions

Peripartum Cardiomyopathy

Interventions

Not provided

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

Jan 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

Feb 20, 2021Actual

Primary Completion Date

Jan 30, 2022Estimated

Completion Date

Feb 28, 2022Estimated

First Submitted Date

Jun 9, 2021

First Submission Date that Met QC Criteria

Jun 15, 2021

First Posted Date

Jun 16, 2021Actual

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

Jan 17, 2022

Last Update Posted Date

Jan 19, 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

this is an observertional study aimed at Study the association between the level of irisin expression and (Fibronectin Type III Domain Containing 5 (FDNC5) gene polymorphism in female patients with peripartum cardiomyopathy.

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

Retention

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diseased		Females with peripartum cardiomyopathy
Control		Healthy females

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Irisin level	detect the serum level of irisin hormone by ELIZA in nanogram/decilitre(ng/dl)	4 months
FNDC5 Genotyping	whether homogenetic or heterogenetic	4 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

This study will include females aged between 18 and 45 years old who have been diagnosed and treated clinically for peripartum cardiomyopathy

Exclusion Criteria:

Age less than 18 or more than 45 year old
females with dilated cardiomyopathy due to other etiology or outside the time frame of occurrence of peripartum cardiomyopathy

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

the studied disease peripartum cardiomyopathy is female specific

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

females who have been diagnosed and treated clinically for peripartum cardiomyopathy in our center in sohag university hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ali mo Altaher, lecturer	Contact	01003376529	+20	dr.ali.altaher30@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag uniersity hosoital	Recruiting	Sohag			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000099088	Peripartum Cardiomyopathy

Ancestor Terms

ID	Term
D011249	Pregnancy Complications, Cardiovascular
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided