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

NCT05107076 | Unknown

• 1 other identifier: PPCI in STEMI patients
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

STEMI - ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation to patients' outcomes especially in those with initial high serum Galactin-3

  40 days

Study Arms (1)

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

Interventions

2D Echocardiography with color Doppler assessment & Galactin-3 level in blood DIAGNOSTIC_TEST

* 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.

STEMI patients who underwent PPCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All patients of sample size admitted to the cardiology department of Assiut university hospital with:
• Acute typical chest pain
• Positive cardiac enzymes.
• ECG shows ST-segment elevation MI
• Documented occlusion of CA then treatment by PPCI

You may not qualify if:

• \. 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.
• \. 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine Assiut University

Asyut, Asyut Governorate, Egypt

RECRUITING

Related 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.

  PMID: 18644161 BACKGROUND

• 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.

  PMID: 21256998 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Echocardiography; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Hatem Helmy, Professor

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariam Hanna, Resident

CONTACT

+201069862210; mariam.abdelmalak@yahoo.com

Yousra Ghazally, Lecturer

CONTACT

+201003314748; Yousraghzally@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mariam Bady Adly Hanna

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 4, 2021
• Study Start: November 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: May 1, 2023
• Last Updated: November 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)