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

NCT04034940 | Unknown

• 1 other identifier: OxiSTEMI01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  1 year

• 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

  1 year

Secondary Outcomes (1)

• Hydation Status in Acute Myocardial Infarction Patients undergoing primary PCI.

  1 year

Study Arms (1)

primary PCI STEMI patients

OTHER

All Patients with AMI refered for primary PCI in single center

Other: Dosing Oxidative stress biomarkers & hFABP in STEMI pPCI patients

Interventions

Dosing Oxidative stress biomarkers & hFABP in STEMI pPCI patients OTHER

Dosing oxidative stress biomarkers and hFABP in STEMI pPCI

primary PCI STEMI patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• Patients who do not sign informed consent for primary PCI

Sponsors & Collaborators

• Grigore T. Popa University of Medicine and Pharmacy: lead
• Cardiovascular Diseases Institute IASI, Romania: collaborator

Study Sites (1)

Cardiovascular Diseases Institute Iasi

Iași, Iaşi, 700503, Romania

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Ventricular Dysfunction, Left

Interventions

Fatty Acid Binding Protein 3

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Ventricular Dysfunction

Intervention Hierarchy (Ancestors)

Fatty Acid-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Adrian Covic, Professor

  University of Medicine and Pharmacy "Gr. T. Popa" Iasi, Romania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Razan Al Namat, MD, PhD stud

CONTACT

0040757205114; dr.razan_romania@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Vice-rector

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 29, 2019
• Study Start: August 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: August 1, 2020
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)