Correlations Between Oxidative Stress Biomarkers, h-FABP and Left Ventricular Dysfunction in Patients With Acute Myocardial Infarction Undergoing Primary PCI

Oxidative Stress Clinical Trial

— OxiSTEMIhFABP  

Official title:

Correlations Between Oxidative Stress Biomarkers, h-FABP and Left Ventricular Dysfunction in Patients With Acute Myocardial Infarction Undergoing Primary PCI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04034940
• Other study ID #: OxiSTEMI01
• Status: Recruiting
• Phase: N/A
• Start date: August 2019
• Est. completion date: August 2020

Study information

• Verified date: July 2019
• Source: Grigore T. Popa University of Medicine and Pharmacy
• Contact: Razan Al Namat, MD, PhD stud
• Phone: 0040757205114
• Email: dr.razan_romania[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators intend to evaluate Oxidative Stress biomarkers through a. Catalase Activity Assay; b. Lipid Peroxidation Assay; c. SOD Assay; d. Total Antioxidant Capacity Assay; e. Glutathione Peroxidase at patients with acute myocardial infarction STEMI referred for primary PCI; The investigators also aim to evaluate cardiac necrosis by measuring Heart Fatty Acid Binding Protein (H-FABP), TnI, CK, CK-MB, LDH and AST in these patients with acute myocardial infarction referred for primary PCI; Also, the investigators intend to evaluate body composition through bioimpedance spectroscopy (BCM - Fresenius Care) at the moment of admission.

The investigators aim to fully characterise these patients through oxidative millieu, hFABP and make correlations with LVEF dysfunction.

Description:

Gathered data:

• Descriptive general demographic data;

• Previous pathologies (ischemic heart disease, peripheral arterial disease, stroke, heart failure, previous percutaneous coronary interventions, coronary artery bypass grafting - CABG, known renal disease);

• Cardiovascular risk factors (age, weight, height, abdominal perimeter, body mass index, smoking, sedentariness, diabetes, hypertension, dyslipidaemia);

• Oxidative Stress biomarkers: Catalase Activity Assay; Lipid Peroxidation Assay; SOD Assay; Total Antioxidant Capacity Assay; Glutathione ;

• Cardiac necrosis markers: Heart Fatty Acid Binding Protein (H-FABP), TnI, CK, CK-MB, LDH and OGT;

• Routine biological data;

• Metabolic data (obtained from two body composition monitoring evaluations - before and 12 hours after coronary intervention) - body water, body fat tissue;

• Information regarding primary PCI (less than 12 hours of ischemic symptoms);

• Coronarographic details, type of used stent, periprocedural specific complications, final TIMI - thrombolysis in myocardial infarction - flow);

• Echocardiography at admission (LVEF);

• Measurement of arterial stiffness through Sphigmocore pulsed-wave-velocity (24 hrs post-procedural, 2 velocities: carotid - femoral and carotid - radial);

• Calculating of cardiovascular risk scores: Syntax Score, Framingham score, ASSIGN score, QRISK2 score, PROCAM score, CRUSADE score, GRACE score, CHADS VASc score, MESA score, ASCVD score, Hamilton Depression Rating Scale (HAM-D), Hamilton Rating Scale for Anxiety;

• In-hospital and one month follow-up MACE.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults with ST elevation Myocardial Infarction (<12h) diagnostic confirmed;

• Included in the Romanian National Programme of Primary Percutaneous Revascularisation (for who the Guidelines recommend primary PCI);

Exclusion Criteria:

• Patients who do not sign informed consent for primary PCI

Related Conditions & MeSH terms

• BCM
• hFABP
• Infarction
• Left Ventricular Dysfunction
• Myocardial Infarction
• Oxidative Stress
• Oxidative Stress Induction
• Primary PCI
• STEMI
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Other:
• Dosing Oxidative stress biomarkers & hFABP in STEMI pPCI patients
Dosing oxidative stress biomarkers and hFABP in STEMI pPCI

Locations

Country	Name	City	State
Romania	Cardiovascular Diseases Institute Iasi	Iasi	Iasi

Sponsors (2)

Lead Sponsor	Collaborator
Grigore T. Popa University of Medicine and Pharmacy	Cardiovascular Diseases Institute IASI, Romania

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxidative Stress status in Acute Myocardial Infarction Patients undergoing primary PCI	Assessment of oxidative stress status by measuring Catalase Activity Assay; Lipid Peroxidation Assay; SOD Assay; Total Antioxidant Capacity Assay; Glutathione Peroxidase.	1 year
Primary	2. Cardiac necrosis status in Acute Myocardial Infarction Patients undergoing primary PCI.	Assessment of cardiac necrosis by measuring Heart Fatty Acid Binding Protein (H-FABP), TnI, CK, CK-MB, LDH and AST	1 year
Secondary	Hydation Status in Acute Myocardial Infarction Patients undergoing primary PCI.	Assessment of hydration status through body composition monitoring BCM.	1 year