Clinical trial NCT04106648: Effect of Significant Ischemic Mitral Regurgitation on the Outcome of ST Segment Elevation Myocardial Infarction Patients Treated With Primary Percutaneous Coronary Intervention
Official title: Effect of Significant Ischemic Mitral Regurgitation on the Outcome of ST Segment Elevation Myocardial Infarction Patients Treated With Primary Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Mitral Regurgitation
Keywords: Ischemic Mitral Regurgitation
primary percutaneous coronary intervention
STEMI
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 134
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with STEMI undergoing PPCI

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

Eligibility criteria: 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

Primary outcomes:
measure: effect of ischemic mitral regurgitation on the outcome of STEMI patients treated with successful primary PCI
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Fady Usama Kostandy, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Hatem Abd El Rahman, Professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Magdy Ibrahim Eldesowky, Lecturer
role: STUDY_DIRECTOR
References: