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

Not Applicable

• Conditions: STEMI; Primary PCI; BCM; Oxidative Stress; Oxidative Stress Induction; hFABP; Left Ventricular Dysfunction
• Interventions: Other: Dosing Oxidative stress biomarkers & hFABP in STEMI pPCI patients

• Registration Number: NCT04034940
• Lead Sponsor: Grigore T. Popa University of Medicine and Pharmacy

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-24
• Study First Submitted QC: 2019-07-24
• Last Update Submitted: 2019-07-27
• Study First Posted: 2019-07-29
• Last Update Posted: 2019-07-30
• Study Start: 2019-08
• Primary Completion: 2020-07
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
primary PCI STEMI patients	Dosing Oxidative stress biomarkers & hFABP in STEMI pPCI patients	All Patients with AMI refered for primary PCI in single center

Primary Outcome Measures

Name	Time	Method
Oxidative Stress status in Acute Myocardial Infarction Patients undergoing primary PCI	1 year	Assessment of oxidative stress status by measuring Catalase Activity Assay; Lipid Peroxidation Assay; SOD Assay; Total Antioxidant Capacity Assay; Glutathione Peroxidase.
2. Cardiac necrosis status in Acute Myocardial Infarction Patients undergoing primary PCI.	1 year	Assessment of cardiac necrosis by measuring Heart Fatty Acid Binding Protein (H-FABP), TnI, CK, CK-MB, LDH and AST

Secondary Outcome Measures

Name	Time	Method
Hydation Status in Acute Myocardial Infarction Patients undergoing primary PCI.	1 year	Assessment of hydration status through body composition monitoring BCM.

Trial Locations

Locations (1)

Cardiovascular Diseases Institute Iasi; 🇷🇴 Iaşi, Iasi, Romania