Effect of Significant Ischemic Mitral Regurgitation on the Outcome of ST Segment Elevation Myocardial Infarction Patients Treated With Primary Percutaneous Coronary Intervention

January 17, 2020 updated by: Fady Usama Amin Kostandy, Assiut University
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

Study Overview

Status

Not yet recruiting

Conditions

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

Study Type

Observational

Enrollment (Anticipated)

134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with STEMI undergoing PPCI

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Rheumatic mitral regurge
  2. Valvular mitral regurge
  3. IMR Grade (II/IV)
  4. Cardiomyopathies
  5. Associated other valvular heart diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2020

Primary Completion (Anticipated)

September 20, 2022

Study Completion (Anticipated)

September 20, 2023

Study Registration Dates

First Submitted

September 25, 2019

First Submitted That Met QC Criteria

September 25, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 17, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ischemic mitral regurgitation

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Pubmed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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