Correlations Between Oxidative Stress Biomarkers, h-FABP and Left Ventricular Dysfunction in Patients With Acute Myocardial Infarction Undergoing Primary PCI (OxiSTEMIhFABP)
Primary Purpose
STEMI, Oxidative Stress, Oxidative Stress Induction
Status
Unknown status
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Dosing Oxidative stress biomarkers & hFABP in STEMI pPCI patients
Sponsored by
About this trial
This is an interventional diagnostic trial for STEMI
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
Sites / Locations
- Cardiovascular Diseases Institute IasiRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
primary PCI STEMI patients
Arm Description
All Patients with AMI refered for primary PCI in single center
Outcomes
Primary Outcome Measures
Oxidative Stress status in Acute Myocardial Infarction Patients undergoing primary PCI
Assessment 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.
Assessment of cardiac necrosis by measuring Heart Fatty Acid Binding Protein (H-FABP), TnI, CK, CK-MB, LDH and AST
Secondary Outcome Measures
Hydation Status in Acute Myocardial Infarction Patients undergoing primary PCI.
Assessment of hydration status through body composition monitoring BCM.
Full Information
NCT ID
NCT04034940
First Posted
July 24, 2019
Last Updated
July 27, 2019
Sponsor
Grigore T. Popa University of Medicine and Pharmacy
Collaborators
Cardiovascular Diseases Institute IASI, Romania
1. Study Identification
Unique Protocol Identification Number
NCT04034940
Brief Title
Correlations Between Oxidative Stress Biomarkers, h-FABP and Left Ventricular Dysfunction in Patients With Acute Myocardial Infarction Undergoing Primary PCI
Acronym
OxiSTEMIhFABP
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
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Grigore T. Popa University of Medicine and Pharmacy
Collaborators
Cardiovascular Diseases Institute IASI, Romania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI, Oxidative Stress, Oxidative Stress Induction, Primary PCI, hFABP, Left Ventricular Dysfunction, BCM
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
primary PCI STEMI patients
Arm Type
Other
Arm Description
All Patients with AMI refered for primary PCI in single center
Intervention Type
Other
Intervention Name(s)
Dosing Oxidative stress biomarkers & hFABP in STEMI pPCI patients
Intervention Description
Dosing oxidative stress biomarkers and hFABP in STEMI pPCI
Primary Outcome Measure Information:
Title
Oxidative Stress status in Acute Myocardial Infarction Patients undergoing primary PCI
Description
Assessment of oxidative stress status by measuring Catalase Activity Assay; Lipid Peroxidation Assay; SOD Assay; Total Antioxidant Capacity Assay; Glutathione Peroxidase.
Time Frame
1 year
Title
2. Cardiac necrosis status in Acute Myocardial Infarction Patients undergoing primary PCI.
Description
Assessment of cardiac necrosis by measuring Heart Fatty Acid Binding Protein (H-FABP), TnI, CK, CK-MB, LDH and AST
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Hydation Status in Acute Myocardial Infarction Patients undergoing primary PCI.
Description
Assessment of hydration status through body composition monitoring BCM.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Razan Al Namat, MD, PhD stud
Phone
0040757205114
Email
dr.razan_romania@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Covic, Professor
Organizational Affiliation
University of Medicine and Pharmacy "Gr. T. Popa" Iasi, Romania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Diseases Institute Iasi
City
Iaşi
State/Province
Iasi
ZIP/Postal Code
700503
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandru Burlacu, MD, PhD
Phone
0040744488580
Email
alburlacu@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.
Learn more about this trial
Correlations Between Oxidative Stress Biomarkers, h-FABP and Left Ventricular Dysfunction in Patients With Acute Myocardial Infarction Undergoing Primary PCI
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