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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-31

Study Completion Date

2020-08-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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primary PCI STEMI patients

All Patients with AMI refered for primary PCI in single center

Group Type OTHER

Dosing Oxidative stress biomarkers & hFABP in STEMI pPCI patients

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiovascular Diseases Institute IASI, Romania

UNKNOWN

Sponsor Role collaborator

Grigore T. Popa University of Medicine and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Professor Adrian Covic

Professor, Vice-rector

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Romania

Central Contacts

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Razan Al Namat, MD, PhD stud

Role: CONTACT

0040757205114

Facility Contacts

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Alexandru Burlacu, MD, PhD

Role: primary

0040744488580

Other Identifiers

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OxiSTEMI01

Identifier Type: -

Identifier Source: org_study_id

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