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

Ischemic Mitral Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04106648
• Other study ID #: Ischemic mitral regurgitation
• Status: Not yet recruiting
• Start date: November 1, 2020
• Est. completion date: September 20, 2023

Study information

• Verified date: January 2020
• Source: Assiut University
• Contact: Fady Usama Kostandy, Msc
• Phone: 1277895809
• Email: f.usama.kostandy[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 134
• Est. completion date: September 20, 2023
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Ischemia
• Ischemic Mitral Regurgitation
• Mitral Valve Insufficiency
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

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