Clinical trial NCT05107076: Effect of PPCI on Diastolic Function & Levels of Galactin-3 in Patients With STEMI
Official title: Effect of PPCI on Diastolic Function & Levels of Galactin-3 in Patients With STEMI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: STEMI - ST Elevation Myocardial Infarction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acute effect of PPCI in STEMI patients on diastolic function and Galactin-3 level
timeFrame: 48 hrs
Secondary outcomes:
measure: Correlation to patients' outcomes especially in those with initial high serum Galactin-3
timeFrame: 40 days
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine Assiut University
state: Asyut
Study officials:
affiliation: Assiut University
name: Hatem Helmy, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.