Effect of PPCI on Diastolic Function & Levels of Galactin-3 in Patients With STEMI

October 25, 2021 updated by: Mariam Bady Adly Hanna, Assiut University
  • 2D Echocardiography with color Doppler assessment: It will be done within 24 h after PPCI
  • Peripheral blood samples were obtained within 48 hours after acute MI, and the serum will be frozen at -70°C until tested for Galactin-3 level.
  • Follow up 2D Doppler echocardiography:

will be repeated at 40 days of the event.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

2D Echocardiography with color Doppler assessment:

It will be done within 24 h after PPCI. Measurements will be as following:

  1. Pulsed wave (PW) Doppler will be performed in the apical 4chamber view within a 3 mm sample volume at the tip of the mitral leaflets to obtain mitral inflow velocities to assess LV filling.
  2. E (early diastolic)/A (late diastolic) - Using PW Doppler, the peak E and A velocities were recorded, then the ratio of E/A will be calculated.
  3. IVRT (isovolumic relaxation time) - derived by placing the cursor of Continuous wave (CW) Doppler in the LV outflow tract to simultaneously display the end of aortic ejection and the onset of mitral inflow.
  4. Deceleration time (DT) - from the peak of E wave to baseline.
  5. E/e'- PW tissue Doppler imaging (TDI) was performed in the apical views to acquire mitral annular velocities. The sample volume will be positioned at or 1 cm within the mitral leaflet's septal and lateral insertion sites.
  6. Left atrial volume and left atrial volume index (LAVI) - The maximal left atrial (LA) volume measured from the apical four-chamber view using the modified Simpson method in end-systole before mitral valve opening. The LAVI obtained for all patients by dividing the LA volume by the body surface area.

Biochemical measurements:

Peripheral blood samples were obtained within 48 hours after acute MI, and the serum will be frozen at -70°C until tested for Galactin-3 level.

Follow up 2D Doppler echocardiography:

All previous echocardiographic measurements will be repeated at 40 days of the event.

Study Type

Observational

Enrollment (Anticipated)

80

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

Study Contact Backup

Study Locations

  • Egypt
    • Asyut
      • Assiut, Asyut, Egypt
        • Recruiting
        • Faculty of Medicine Assiut University
        • Contact:
          • Mariam Hanna

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients with age > 18 years who will present in the emergency department within 12 h (hrs) of the onset of ischemic chest pain & fulfill the diagnostic criteria of acute STEMI as defined by the universal definition of Myocardial Infarction (9) and are eligible for primary PCI will be included in this study.

Description

Inclusion Criteria:

  • All patients of sample size admitted to the cardiology department of Assiut university hospital with:

    1. Acute typical chest pain
    2. Positive cardiac enzymes.
    3. ECG shows ST-segment elevation MI
    4. Documented occlusion of CA then treatment by PPCI

Exclusion Criteria:

  • 1. Patients with well-known factors of left ventricular diastolic dysfunctions, including high blood pressure (over 140/90 mmHg), hypertrophic cardiomyopathy, left ventricular hypertrophy, bundle branch block, ventricular fibrillation, ventricular arrhythmia, severe valvular disease, complete heart block, and previous CABG.

    2. Patients with the end-stage renal disease usually have markedly increased galactin-3 levels 3. Prior use of thrombolytic agents 4. Refusal of PPCI due to social or religious concerns 5. ST elevation on ECG without obvious coronary artery diseases such as acute myocarditis, early repolarization, or Takotsubo cardiomyopathy 6. Atrial fibrillation at the time of echocardiography examination.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
STEMI patients who underwent PPCI

2D Echocardiography with color Doppler assessment will be done within 24 h after PPCI

Biochemical measurements:

Peripheral blood samples were obtained within 48 hours after acute MI, and the serum will be frozen at -70°C until tested for Galactin-3 level.

Follow up 2D Doppler echocardiography will be repeated at 40 days of the event.
Diagnostic test: 2D Echocardiography with color Doppler assessment & Galactin-3 level in blood

  • Measurements will be

    1. Pulsed wave (PW) Doppler
    2. E (early diastolic)/A (late diastolic) - Using PW Doppler
    3. IVRT (isovolumic relaxation time)
    4. Deceleration time (DT) - from the peak of E wave to baseline.
    5. E/e'- PW tissue Doppler imaging (TDI)
    6. Left atrial volume and left atrial volume index (LAVI)
  • Peripheral blood samples will be obtained within 48 hours after acute MI, and the serum will be frozen at -70°C until tested for Galactin-3 level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute effect of PPCI in STEMI patients on diastolic function and Galactin-3 level
Time Frame: 48 hrs
Determine the acute effect of PPCI in STEMI patients on the level of Galectin 3 and diastolic function within 48 hrs of the event.
48 hrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation to patients' outcomes especially in those with initial high serum Galactin-3
Time Frame: 40 days
Correlating effect of PPCI on patients outcomes and impact on diastolic function, with consideration to those with initial high serum galectin levels at 40 days of the procedure.
40 days

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Hatem Helmy, Professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2021

Primary Completion (ANTICIPATED)

January 1, 2023

Study Completion (ANTICIPATED)

May 1, 2023

Study Registration Dates

First Submitted

October 25, 2021

First Submitted That Met QC Criteria

October 25, 2021

First Posted (ACTUAL)

November 4, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 25, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPCI in STEMI patients

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on STEMI - ST Elevation Myocardial Infarction

Clinical Trials on 2D Echocardiography with color Doppler assessment & Galactin-3 level in blood

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe