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

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.

Study Overview

• Status: Unknown
• Conditions: Oxidative Stress; STEMI; Left Ventricular Dysfunction; Oxidative Stress Induction; Primary PCI; hFABP; BCM
• Intervention / Treatment: Other: Dosing Oxidative stress biomarkers & hFABP in STEMI pPCI patients

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Razan Al Namat, MD, PhD stud; Phone Number: 0040757205114; Email: dr.razan_romania@yahoo.com

Study Locations

• Romania
  • Iasi
    • Iaşi, Iasi, Romania, 700503
      • Recruiting
      • Cardiovascular Diseases Institute Iasi
      • Contact: Alexandru Burlacu, MD, PhD; Phone Number: 0040744488580; Email: alburlacu@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: primary PCI STEMI patients; All Patients with AMI refered for primary PCI in single center	Other: Dosing Oxidative stress biomarkers & hFABP in STEMI pPCI patients; Dosing oxidative stress biomarkers and hFABP in STEMI pPCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hydation Status in Acute Myocardial Infarction Patients undergoing primary PCI.	Assessment of hydration status through body composition monitoring BCM.	1 year

Collaborators and Investigators

• Sponsor: Grigore T. Popa University of Medicine and Pharmacy
• Collaborators: Cardiovascular Diseases Institute IASI, Romania
• Investigators: Principal Investigator: Adrian Covic, Professor, University of Medicine and Pharmacy "Gr. T. Popa" Iasi, Romania

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: July 24, 2019
• First Posted (Actual): July 29, 2019

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 27, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ventricular Dysfunction; Ventricular Dysfunction, Left
• Other Study ID Numbers: OxiSTEMI01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No