Evaluation of the Predictive Effect of Inflammatory Markers in MI Patients

NCT05479838 | Unknown

• 1 other identifier: BAIBU-EM-MED-1
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Acute myocardial infarction (AMI), triggered by myocardial ischemia and reperfusion injury, is a disease with high morbidity and mortality, and there is a tendency for its incidence to increase at younger ages. One of the most worrisome complications of primary percutaneous surgery is contrast-induced nephropathy, which is associated with increased mortality and morbidity in myocardial infarction after coronary interventions. In many studies, inflammatory markers, which are thought to give an idea about the development of contrast-related nephropathy, have been examined. The transcription factor nuclear factor erythroid 2-related factor 2 (Nrf2) is a master regulator of cytoprotective protein expression driven by antioxidant response agents (AREs) and plays a decisive role in the regulation of oxidative defense and redox homeostasis in cells. There are studies showing the role of Nrf2 in the pathogenesis of kidney damage in some studies. Studies on the effect of Nrf2 level on contrast media nephropathy in patients with contrast media nephropathy (CIN) are limited in the literature. This study also aimed to form a basis for the literature, which is a small number of studies, in later studies.

Conditions

Myocardial Infarction

Keywords

Myocardial Infarction; Nephropathy; Inflammation Mediators

Outcome Measures

Primary Outcomes (1)

• Nuclear factor erythroid 2-related factor 2 levels

  The blood taken from the patients into biochemistry tubes at the time of application will be centrifuged at 1500 g for 10 minutes after the clotting process is completed, and their serum will be separated and stored at -80 C until the working day. On the working day, samples will be thawed and Nrf2 levels will be measured using commercially available kits. Nuclear Factor Erythroid 2-Related Factor 2 (BtLab) Product Summary Size: 96T Sensitivity: 0.11ng/ml Detection range: 0.2-60ng/ml Sample type: Serum, plasma, cell culture supernates Reactive with: Human https://www.bt-laboratory.com/index.php/Shop/Index/productShijiheDetail/p\_id/987/cate/kit.html

  30 minutes

Secondary Outcomes (1)

• Troponin

  30 minutes

Study Arms (1)

ST Elevation MI

ST-segment in adjacent ≥2 leads Elevation ( ≥2 mm in precordial leads, ≥1 mm in extremity leads) or left bundle branch block, ischemic type chest pain lasting longer than 30 minutes, and two or more elevations of serum creatine kinase myocardial band and troponin levels will be used as diagnostic criteria for STEMI. Patients with ST-elevation on the ECG will be referred to as STEMI, non -STEMI with twice the troponin level despite the absence of ST elevation. Patients who do not have ST elevation on ECG and whose troponin values do not exceed the reference range, but who are diagnosed as USAP presenting with typical chest pain and undergoing coronary angiography will be included in the study.

Procedure: Percutaneous coronary intervention

Interventions

Percutaneous coronary intervention PROCEDURE

Coronary angiography will be performed via the femoral or radial artery, and primary PCI will be performed using standard guide catheters, guide wires, balloon catheters, and stents according to current guidelines. All PCI interventions performed by invasive cardiologists. The primary PCI type and contrast amount will be decided by the medical team. All patients will be treated by administering non-ionic, monomeric, low-osmolar iodinated iohexol as an intravascular contrast agent .

ST Elevation MI

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients included in the study will be followed up after the percutaneous intervention with routine controls. CIN identification; Renal dysfunction (a 0.3 mg/dl increase in absolute serum creatinine or at least 1.5-fold increase in basal creatinine) within 7 days of intravenous contrast administration and contrast nephropathy as recommended by the Journal of the American College of Cardiology will be defined. Diagnosis, treatment, follow-up and discharge of patients will proceed according to routine medical procedures. In this study, a different procedure related to diagnosis, treatment, follow-up and discharge will not be used.

You may qualify if:

• Those diagnosed with STEMI

You may not qualify if:

• Under 18 years of age
• With other clinical diagnoses in ED
• Pregnancy
• Acute or chronic kidney failure
• Malignancy
• Active infection
• Rheumatoid Diseases
• If patient want leave study
• Mortality in 28 days

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant Izzet University faculty of Medicine Department of Emercengy Medicine

Bolu, Merkez, 14010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myocardial Infarction; Kidney Diseases

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Mustafa Enes DEMİREL, M.D.

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramazan Kurul, Ph.D

CONTACT

+905436414731; ramazankurul2@otmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: July 29, 2022
• Study Start: October 15, 2022
• Primary Completion: August 15, 2023
• Study Completion: September 15, 2023
• Last Updated: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)