Myocardial InfarctionNCT05479838
Evaluation of the Predictive Effect of Inflammatory Markers in MI Patients
An observational study of Myocardial Infarction, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2022to 15 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Those diagnosed with STEMI
Who cannot join
- Under 18 years of age
- With other clinical diagnoses in ED
- Pregnancy
- Acute or chronic kidney failure
- Malignancy
- Active infection
Show all 9Show fewer
- Rheumatoid Diseases
- If patient want leave study
- Mortality in 28 days
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant Izzet University faculty of Medicine Department of Emercengy Medicine
Bolu, Merkez, 14010
Muhammed Nur ÖĞÜN, M.D., +905072329466, drmogun@gmail.com
Mustafa Enes DEMİREL, M.D.
About this study
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.
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.
Read more
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.
- Conditions
- Myocardial Infarction
- Being tested
- Percutaneous coronary intervention
- Keywords
- Myocardial Infarction, Nephropathy, Inflammation Mediators
- Medical subject headings
- Myocardial Infarction, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionProcedure or surgery
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 .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start15 Oct 2022 (estimated)
- Primary completion15 Aug 2023 (estimated)
- Study completion15 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Enes DEMİREL, Abant Izzet Baysal University
- Investigators
- Mustafa Enes DEMİREL, M.D., Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479838
- Sponsor's protocol ID
- BAIBU-EM-MED-1
- Status last verified
- Sep 2022
- First submitted
- 27 Jul 2022
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05479838
- Acronym / sponsor ID
- BAIBU-EM-MED-1
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial Infarction, Nephropathy, Inflammation Mediators
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (estimated)
- Primary completion
- 15 Aug 2023 (estimated)
- Study completion
- 15 Sep 2023 (estimated)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ST Elevation MI | – | Procedure: Percutaneous coronary interventionST-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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Those diagnosed with STEMI
Key exclusion criteria (9 listed)
- Under 18 years of age
- With other clinical diagnoses in ED
- Pregnancy
- Acute or chronic kidney failure
- Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary interventionCoronary 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 . | Procedure or surgery | ST Elevation MI |
Primary outcome
Nuclear factor erythroid 2-related factor 2 levels
Time frame: 30 minutes
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
1 secondary outcome
Troponin
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustafa Enes DEMİREL, M.D. principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ramazan Kurul, Ph.D (+905436414731, ramazankurul2@otmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nuclear factor erythroid 2-related factor 2 levels (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.