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

STEMI - ST Elevation Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05107076
• Other study ID #: PPCI in STEMI patients
• Status: Recruiting
• Start date: November 2021
• Est. completion date: May 2023

Study information

• Verified date: October 2021
• Source: Assiut University
• Contact: Mariam Hanna, Resident
• Phone: +201069862210
• Email: mariam.abdelmalak[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

• 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI - ST Elevation Myocardial Infarction

Intervention

Diagnostic Test:
• 2D Echocardiography with color Doppler assessment & Galactin-3 level in blood
Measurements will be Pulsed wave (PW) Doppler E (early diastolic)/A (late diastolic) - Using PW Doppler IVRT (isovolumic relaxation time) Deceleration time (DT) - from the peak of E wave to baseline. E/e'- PW tissue Doppler imaging (TDI) 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.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Assiut University	Assiut	Asyut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Karaye KM, Sani MU. Factors associated with poor prognosis among patients admitted with heart failure in a Nigerian tertiary medical centre: a cross-sectional study. BMC Cardiovasc Disord. 2008 Jul 22;8:16. doi: 10.1186/1471-2261-8-16. — View Citation

McManus DD, Chinali M, Saczynski JS, Gore JM, Yarzebski J, Spencer FA, Lessard D, Goldberg RJ. 30-year trends in heart failure in patients hospitalized with acute myocardial infarction. Am J Cardiol. 2011 Feb 1;107(3):353-9. doi: 10.1016/j.amjcard.2010.09.026. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute effect of PPCI in STEMI patients on diastolic function and Galactin-3 level	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	Correlation to patients' outcomes especially in those with initial high serum Galactin-3	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