Clinical trial NCT04034940: Correlations Between Oxidative Stress Biomarkers, h-FABP and Left Ventricular Dysfunction in Patients With Acute Myocardial Infarction Undergoing Primary PCI
Official title: Correlations Between Oxidative Stress Biomarkers, h-FABP and Left Ventricular Dysfunction in Patients With Acute Myocardial Infarction Undergoing Primary PCI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: STEMI
Oxidative Stress
Oxidative Stress Induction
Primary PCI
hFABP
Left Ventricular Dysfunction
BCM
Lead sponsor: Grigore T. Popa University of Medicine and Pharmacy
Sponsor class: OTHER
Collaborators: name: Cardiovascular Diseases Institute IASI, Romania
First posted: 2019-07-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oxidative Stress status in Acute Myocardial Infarction Patients undergoing primary PCI
timeFrame: 1 year
measure: 2. Cardiac necrosis status in Acute Myocardial Infarction Patients undergoing primary PCI.
timeFrame: 1 year
Secondary outcomes:
measure: Hydation Status in Acute Myocardial Infarction Patients undergoing primary PCI.
timeFrame: 1 year
Other outcomes:
Locations:
city: Iaşi
country: Romania
facility: Cardiovascular Diseases Institute Iasi
state: Iasi
Study officials:
affiliation: University of Medicine and Pharmacy "Gr. T. Popa" Iasi, Romania
name: Adrian Covic, Professor
role: PRINCIPAL_INVESTIGATOR
References: