Correlations Between Oxidative Stress Biomarkers, h-FABP and Left Ventricular Dysfunction in Patients With Acute Myocardial Infarction Undergoing Primary PCI
NCT ID: NCT04034940
Last Updated: 2019-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2019-08-31
2020-08-31
Brief Summary
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The investigators aim to fully characterise these patients through oxidative millieu, hFABP and make correlations with LVEF dysfunction.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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primary PCI STEMI patients
All Patients with AMI refered for primary PCI in single center
Dosing Oxidative stress biomarkers & hFABP in STEMI pPCI patients
Dosing oxidative stress biomarkers and hFABP in STEMI pPCI
Interventions
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Dosing Oxidative stress biomarkers & hFABP in STEMI pPCI patients
Dosing oxidative stress biomarkers and hFABP in STEMI pPCI
Eligibility Criteria
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Inclusion Criteria
* Included in the Romanian National Programme of Primary Percutaneous Revascularisation (for who the Guidelines recommend primary PCI);
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Cardiovascular Diseases Institute IASI, Romania
UNKNOWN
Grigore T. Popa University of Medicine and Pharmacy
OTHER
Responsible Party
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Professor Adrian Covic
Professor, Vice-rector
Principal Investigators
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Adrian Covic, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Medicine and Pharmacy "Gr. T. Popa" Iasi, Romania
Locations
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Cardiovascular Diseases Institute Iasi
Iași, Iaşi, Romania
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OxiSTEMI01
Identifier Type: -
Identifier Source: org_study_id
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