Long Term Follow Up and Outcome of Left Ventricular Remodeling in ST Segment Myocardial Infarction Patients After pPCI

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03888781
Collaborator
(none)
127
13

Study Details

Study Description

Brief Summary

  • To detect long-term effects of left ventricular remodeling in STEMI patients undergoing PPCI.

  • And to evaluate outcome.

Condition or Disease Intervention/Treatment Phase
  • Device: Echocardiography

Detailed Description

Acute myocardial infarction (AMI) with its accompanying adverse sequelae remains one of the most common causes of morbidity and mortality in the world .

Reperfusion therapy is by far the most important therapy for the treatment of acute MI. Reperfusion of the ischemic myocardium reduces the infarct size and improves left ventricular function, both of which contribute to an improved clinical outcome in patients with acute MI .

Using primary PCI has reduced the mortality of patients with acute MI . However, the increased survival rate resulted in the increased incidence of cardio vascular events mainly due to LV remodeling and congestive heart failure .

Post-infarct ventricular remodeling develops in about 30% of patients with a history of myocardial infarction. Ventricular remodeling is a predictor of heart failure and for this reason it assumes a negative prognostic value .

Left ventricular remodeling after ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention is a major determinant for the short-term and long-term clinical outcomes . Adverse left ventricular remodeling refers to alterations in ventricular architecture involving both the infarcted and non-infarcted zones leading to progressive increase in systolic and diastolic left ventricular volumes.

Left ventricular remodeling following a ST-segment elevated myocardial infarction (STEMI) is an adaptive response to maintain the cardiac output despite myocardial tissue loss. Limited studies have evaluated long term ventricular function after STEMI.

Left Ventricular remodeling, both positive and negative, is an ongoing process and continues at least up to 2 years after STEMI, involving the infarct zone and remote zones. Long-term left ventricular ejection fraction (LVEF) deterioration is characterized by an increase in end-systolic volume and less wall thickening in the remote zones. Patients with long-term LVEF improvement exhibit an increase in left ventricular wall thickening both in the transmural infarct and remote zones. For elucidation of long term effects of left ventricular remodeling, the current study is conducted.

Study Design

Study Type:
Observational
Anticipated Enrollment :
127 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Long Term Follow Up and Outcome of Left Ventricular Remodeling in ST Segment Myocardial Infarction Patients After Primary Percutaneous Coronary Intervention
Anticipated Study Start Date :
May 1, 2019
Anticipated Primary Completion Date :
May 1, 2020
Anticipated Study Completion Date :
Jun 1, 2020

Arms and Interventions

Arm Intervention/Treatment
With Left Ventricular Remodeling

By Echocardiography

Device: Echocardiography
An echocardiogram (also called an echo) is a type of ultrasound test that uses high-pitched sound waves that are sent through a device called a transducer. The device picks up echoes of the sound waves as they bounce off the different parts of your heart. These echoes are turned into moving pictures of your heart that can be seen on a video screen.

Without Left Ventricular Remodeling

By Echocardiography

Device: Echocardiography
An echocardiogram (also called an echo) is a type of ultrasound test that uses high-pitched sound waves that are sent through a device called a transducer. The device picks up echoes of the sound waves as they bounce off the different parts of your heart. These echoes are turned into moving pictures of your heart that can be seen on a video screen.

Outcome Measures

Primary Outcome Measures

  1. Long term effect of primary percutaneous coronary intervention on left ventricular remodeling, as measured by change in left ventricular ejection fraction (LVEF) at one year [one year]

    Left ventricular remodeling follow up to 127 of acute STEMI patients to whom PPCI were done by 2D Echocardiography measurement to left ventricular ejection fraction change by modified simpthon method

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • All patients were treated successfully by primary PCI more than 2 years ago within 12 hours of onset of chest pain or up to 24 hour of onset of chest pain if there was ongoing ischemia at Assiut University Cardiac Hospital Cath. lab.
Exclusion Criteria:
  • Patients with clinical manifestations of acute heart failure or cardiogenic shock at presentation.

  • Significant Mitral regurgitation or valve disease.

  • Patients with permanent pacemaker insertion.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yara Amir Adly Eskander, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT03888781
Other Study ID Numbers:
  • Long Term LV Remodeling
First Posted:
Mar 25, 2019
Last Update Posted:
Mar 25, 2019
Last Verified:
Mar 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 25, 2019