CClinicalTrials.gg
Status unknownNCT05479838Updated Oct 3, 2022

Evaluation of the Predictive Effect of Inflammatory Markers in MI Patients

An observational study in Myocardial Infarction, sponsored by Abant Izzet Baysal University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-10-03.

Sponsored by Abant Izzet Baysal University · Observational

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Myocardial Infarction

Keywords

  • Myocardial Infarction
  • Nephropathy
  • Inflammation Mediators
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's planned enrollment of 60 is below the median of 500 across 983 observational studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Abant Izzet Baysal University is the lead sponsor of 242 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • Those diagnosed with STEMI

Exclusion criteria

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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedurePercutaneous 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 .

06

What researchers measure

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

    Time frame: 30 minutes

Secondary outcomes

  1. 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.

    Time frame: 30 minutes

07

Study locations

1 site
  • Bolu Abant Izzet University faculty of Medicine Department of Emercengy Medicine
    Bolu, Merkez 14010, Turkey
    • Muhammed Nur ÖĞÜN, M.D. · Contact · drmogun@gmail.com · +905072329466
    • Mustafa Enes DEMİREL, M.D. · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05479838
Lead sponsor
Abant Izzet Baysal University
Responsible party
Mustafa Enes DEMİREL (Assist. Prof., Abant Izzet Baysal University) — Principal investigator
First posted
Jul 29, 2022
Start date
Oct 15, 2022 (estimated)
Primary completion
Aug 15, 2023 (estimated)
Completion
Sep 15, 2023 (estimated)
Last update
Oct 3, 2022

Study contacts

Ramazan Kurul, Ph.D
Contact
ramazankurul2@otmail.com
+905436414731
Mustafa Enes DEMİREL, M.D.
principal investigator · Abant Izzet Baysal University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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