Effect of Significant Ischemic Mitral Regurgitation on th... | NCT04106648

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2020Estimated

Primary Completion Date

Sep 20, 2022Estimated

Completion Date

Sep 20, 2023Estimated

First Submitted Date

Sep 25, 2019

First Submission Date that Met QC Criteria

Sep 25, 2019

First Posted Date

Sep 27, 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

Jan 17, 2020

Last Update Posted Date

Jan 22, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fady Usama Amin Kostandy, Principal investigator, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

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 goal of the study is to correlate the effect of ischemic mitral regurgitation on the outcome of STEMI patients treated with successful primary PCI using clinical data and echocardiography on presentation and during short term follow up after 3 months

Detailed Description

IMR is defined as mitral regurgitation (MR) caused by chronic changes of LV structure and function due to ischemic heart disease. It is not a valve disease but represents the valvular consequences of increased tethering forces and reduced closing forces. It is reported in approximately one-fifth of patients following acute myocardial infarction (MI) and one-half of those with congestive heart failure. IMR is a frequent complication of coronary artery disease and it worsens the prognosis.
It is important to distinguish between primary MR due to organic disease of one or more components of the mitral valve apparatus and secondary MR which is not a valve disease, but represents LV disease. Secondary MR is defined as functional MR, due to LV remodeling by cardiomyopathy or coronary artery disease. In the latter clinical setting, secondary functional MR is called IMR. There are some limitations in this definition of functional IMR. Recent studies have revealed evidence of structural changes in the mitral leaflets in response to tethering on them by LV pathological remodeling. The leaflet adaptation includes enlargement and increased stiffness.
Aim of the work :

To correlate the effect of ischemic mitral regurgitation on the outcome of STEMI patients treated with successful primary PCI using clinical data and echocardiography on presentation and during short term follow up after 3 months

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

134Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
effect of ischemic mitral regurgitation on the outcome of STEMI patients treated with successful primary PCI	clinical data and echocardiography	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with first presentation
Subjects with Acute STEMI
Subjects undergoing Primary PCI with Successful reperfusion
Subjects with significant IMR Grade (III/IV) to (IV/IV)
Subjects with acute STEMI with no or non-significant MR undergoing Primary PCI undergoing primary PCI with successful reperfusion (as control)

Exclusion Criteria:

Rheumatic mitral regurge
Valvular mitral regurge
IMR Grade (II/IV)
Cardiomyopathies
Associated other valvular heart diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with STEMI undergoing PPCI

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fady Usama Kostandy, Msc	Contact	1277895809	+20	f.usama.kostandy@gmail.com

Overall Officials

Name	Affiliation	Role
Fady Usama Kostandy, Msc	Assiut University	Principal Investigator
Hatem Abd El Rahman, Professor	Assiut University	Study Director
Magdy Ibrahim Eldesowky, Lecturer

Locations

Not provided

ID	Type	URL	Comment
	Pubmed	View IPD

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

No data available

No data is available for this block.

ID	Term
D000072657	ST Elevation Myocardial Infarction

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis