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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04034940
Acronym
OxiSTEMIhFABP
Enrollment
200
Registered
2019-07-29
Start date
2019-08-31
Completion date
2020-08-31
Last updated
2019-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERDosing Oxidative stress biomarkers & hFABP in STEMI pPCI patients

Dosing oxidative stress biomarkers and hFABP in STEMI pPCI

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Oxidative Stress status in Acute Myocardial Infarction Patients undergoing primary PCI1 yearAssessment 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 yearAssessment of cardiac necrosis by measuring Heart Fatty Acid Binding Protein (H-FABP), TnI, CK, CK-MB, LDH and AST

Secondary

MeasureTime frameDescription
Hydation Status in Acute Myocardial Infarction Patients undergoing primary PCI.1 yearAssessment of hydration status through body composition monitoring BCM.

Countries

Romania

Contacts

Primary ContactRazan Al Namat, MD, PhD stud
dr.razan_romania@yahoo.com0040757205114

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026