Evaluation of the Predictive Effect of Inflammatory Markers in MI Patients

Myocardial Infarction Clinical Trial

Official title:

Evaluation of the Predictive Effect of Inflammatory Markers in Predicting the Occurrence of Post-PCI Nephrotoxicity in MI Patients Admitted to the Emergency Department.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05479838
• Other study ID #: BAIBU-EM-MED-1
• Status: Not yet recruiting
• Start date: October 15, 2022
• Est. completion date: September 15, 2023

Study information

• Verified date: September 2022
• Source: Abant Izzet Baysal University
• Contact: Ramazan Kurul, Ph.D
• Phone: +905436414731
• Email: ramazankurul2[@]otmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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 and acute renal failure, which is associated with increased mortality and morbidity in myocardial infarction after coronary interventions. In many studies, markers that are thought to give an idea about the development of contrast-associated nephropathy have been examined. Acute renal failure (ARF) refers to a sudden decrease in glomerular tissue. Glomerular filtration rate (GFR) causes creatinine accumulation in the body and decreased urine output for various reasons, causing serious complications. Apart from dysfunction during the acute phase, there is a significant risk for permanent tissue damage. Therefore, kidney function cannot be restored, leading to the development of chronic renal failure (CKD), a sustained decrease in GFR, and increased long-term mortality. Incomplete recovery can also lead to the onset or further deterioration of chronic renal failure. Clinically, apart from hemodialysis treatment, few effective methods can treat the formation and development of ARF. Therefore, there is still an urgent need for new targets or better treatment options to prevent ARF and promote adaptive repair after ARF occurs. To date, the molecular mechanism of ARF is unclear, but there is increasing evidence that ARF is directly related to oxidative stress. In some studies, there are studies showing the role of Transcription factor nuclear factor erythroid 2-related factor 2 (Nrf2) in the pathogenesis of kidney damage.

There is an increase in mortality and morbidity rates due to nephrotoxicity after percutaneous intervention after MI. Studies showing that Nrf2 level may have a protective effect in contrast media nephropathy in patients with contrast media nephropathy (CIN) are limited in the literature.

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. Although there are studies examining the epidemiological, demographic and clinical characteristics of patients in our country, studies on the importance of inflammatory parameters and the mortality and morbidity of Nrf2 levels are not available in our country.

This study aimed to form the basis of the literature, which is a small number of studies, in later studies.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Those diagnosed with STEMI

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Procedure:
• Percutaneous coronary intervention
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 .

Locations

Country	Name	City	State
Turkey	Bolu Abant Izzet University faculty of Medicine Department of Emercengy Medicine	Bolu	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Troponin	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 Troponin levels will be measured using commercially available kits.	30 minutes