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

G

Grigore T. Popa University of Medicine and Pharmacy

Status

Unknown

Conditions

BCM
hFABP
Oxidative Stress Induction
Oxidative Stress
Left Ventricular Dysfunction
STEMI
Primary PCI

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04034940
OxiSTEMI01

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

200 participants in 1 patient group

primary PCI STEMI patients
Other group
Description:
All Patients with AMI refered for primary PCI in single center
Treatment:
Other: Dosing Oxidative stress biomarkers & hFABP in STEMI pPCI patients

Trial contacts and locations

1

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Central trial contact

Razan Al Namat, MD, PhD stud

Data sourced from clinicaltrials.gov

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