Myocardial InfarctionNCT04243876
Decrease in Paraoxonase Enzyme Level and Myocardial İnfarction
An observational study of Myocardial Infarction and High-Density Lipoid Deficiency, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Myocardial infarction is a polygenic disease that may occur due to various environmental risk factors. Mortality risk of the disease; sex, age, smoking, systolic blood pressure, total cholesterol, and high-density lipoprotein levels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction, High-Density Lipoid Deficiency
- What is being tested?
- paraoxanase enzyme level
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2019to 27 May 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients admitted to the emergency department over the age of 18
Who may be able to join
- Those over the age of 18
- All acute coronary syndrome patients
Who cannot join
- Patients with normal angiography
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem vakif university
Istanbul, Eyalet/Yerleşke, 34093
About this study
Official title: Comparison of the Relationship Between Age and Serum Paraoxonase /Arylesterase Activity of Patients With Acute Coronary Syndrome Presenting to the Emergency Department''
Myocardial infarction is a polygenic disease that may occur due to various environmental risk factors. Mortality risk of the disease; sex, age, smoking, systolic blood pressure, total cholesterol, and high-density lipoprotein levels. The paraoxonase-1 phenotype is expressed as the paraoxonase/arylesterase ratio and is closely related to high-density lipoprotein, acting as an endogenous defense mechanism against vascular oxidative stress, thus contributing to the prevention of atherosclerosis. Serum concentration and activity depend on environmental factors as well as genetic polymorphism. This decrease in enzyme concentration causes changes in gene expression (1). Numerous data on Paraoxonase-1 levels have been found in studies, especially with decreasing serum paraoxonase and arylesterase activities with age, associated with increased risk of systemic oxidative stress and atherosclerosis in humans. Many studies have shown that serum Paraoxonase-1 activity is significantly reduced in people with myocardial infarction, dyslipidemia, atherosclerosis, and chronic kidney disease. The most important risk factor for these and similar diseases is aging. Diversity of conditions such as genetic predisposition, malnutrition, stress, and smoking, which increases vascular dysfunction due to oxidative stress, classify individuals with acute myocardial infarction according to age groups and investigate whether there is a relationship between serum Paraoxonase-1 activity and severity of coronary artery disease in young patients. The paraoxonase-1 enzyme, which is known to decrease blood levels with age, is found to be significantly lower in patients with myocardial infarction at a young age compared to the healthy control group.
Read the detailed description
High-density lipoprotein (HDL), known as good cholesterol, is named because of its protective effects on the cardiovascular system. in order to summarize the mechanism of the event, cholesterol is transported from the liver to the cells and from the cells back to the liver via blood. Cholesterol and other fats are carried in packets called lipoprotein to dissolve in the blood. Those with these are two kinds of cholesterol, these low-density lipoproteins and good cholesterol can help to lower the cholesterol as well. LDL cholesterol is the main package that carries cholesterol in the blood. When the blood is high, it sticks to the inside of the veins and forms plaques around here. With the addition of cholesterol, a blood clot that formed in cracks that occur on these plaques grow the arteries and clogs them. If the blockage occurs in the heart vessels, it can cause a heart attack and stroke. Cholesterol in the blood is a part of a package called HDL-cholesterol is carried in. HDL-cholesterol prevents the accumulation of cholesterol in the veins.
It collects the cholesterol circulating in the blood and brings it to the liver to get rid of it from the body. Thus, it reduces the exposure of blood vessels to the harmful effects of cholesterol. All these effects of HDL cholesterol in the paraoxonase enzyme owes. This may be the reason why Dolat may even use another nomenclature instead of HDL in future years. A paraoxonase-1 enzyme, which is known to decrease blood level with age, is found to be significantly lower in patients with myocardial infarction at a young age compared with the healthy control group in this study, and the measurement of this enzyme level can be used as a screening test in people with risk factors.
- Being tested
- paraoxanase enzyme level
- Keywords
- Myocardial infarction, Paraoxonase
- Medical subject headings
- Myocardial Infarction, Hypoalphalipoproteinemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paraoxanase enzyme levelDiagnostic test
Also called troponin level, HDL level
presence of paraoxonase enzyme deficiency and associated troponin elevation
| Study group | Role | What they receive |
|---|---|---|
| paraoxanase | Enzyme level Receives: Diagnostic Test: paraoxanase enzyme level | |
| Myocardial infarction | RESULTS OF ANGIOGRAPHY Receives: Diagnostic Test: paraoxanase enzyme level |
What is being measured
The primary outcome is the main question the study is designed to answer.
early diagnosis
paraoxonase enzyme measurement
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start30 Dec 2019
- Primary completion27 May 2022
- Study completion27 May 2022
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.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahadir Taslidere, Bezmialem Vakif University
- Investigators
- bahadir taslidere, Principal investigator, BEZMİALEM VAKİF UNİVERSİTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243876
- Sponsor's protocol ID
- 20/9
- Status last verified
- May 2022
- First submitted
- 31 Dec 2019
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: nope
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Relationship Between Age and Serum Paraoxonase /Arylesterase Activity of Patients With Acute Coronary Syndrome Presenting to the Emergency Department''
- ClinicalTrials.gov ID
- NCT04243876
- Acronym / sponsor ID
- 20/9
- Keywords
- Myocardial infarction, Paraoxonase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 28 Jan 2020 (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.
Myocardial infarction is a polygenic disease that may occur due to various environmental risk factors. Mortality risk of the disease; sex, age, smoking, systolic blood pressure, total cholesterol, and high-density lipoprotein levels. The paraoxonase-1 phenotype is expressed as the paraoxonase/arylesterase ratio and is closely related to high-density lipoprotein, acting as an endogenous defense mechanism against vascular oxidative stress, thus contributing to the prevention of atherosclerosis. Serum concentration and activity depend on environmental factors as well as genetic polymorphism. This decrease in enzyme concentration causes changes in gene expression (1). Numerous data on Paraoxonase-1 levels have been found in studies, especially with decreasing serum paraoxonase and arylesterase activities with age, associated with increased risk of systemic oxidative stress and atherosclerosis in humans. Many studies have shown that serum Paraoxonase-1 activity is significantly reduced in people with myocardial infarction, dyslipidemia, atherosclerosis, and chronic kidney disease. The most important risk factor for these and similar diseases is aging. Diversity of conditions such as genetic predisposition, malnutrition, stress, and smoking, which increases vascular dysfunction due to oxidative stress, classify individuals with acute myocardial infarction according to age groups and investigate whether there is a relationship between serum Paraoxonase-1 activity and severity of coronary artery disease in young patients. The paraoxonase-1 enzyme, which is known to decrease blood levels with age, is found to be significantly lower in patients with myocardial infarction at a young age compared to the healthy control group.
Detailed description
High-density lipoprotein (HDL), known as good cholesterol, is named because of its protective effects on the cardiovascular system. in order to summarize the mechanism of the event, cholesterol is transported from the liver to the cells and from the cells back to the liver via blood. Cholesterol and other fats are carried in packets called lipoprotein to dissolve in the blood. Those with these are two kinds of cholesterol, these low-density lipoproteins and good cholesterol can help to lower the cholesterol as well. LDL cholesterol is the main package that carries cholesterol in the blood. When the blood is high, it sticks to the inside of the veins and forms plaques around here. With the addition of cholesterol, a blood clot that formed in cracks that occur on these plaques grow the arteries and clogs them. If the blockage occurs in the heart vessels, it can cause a heart attack and stroke. Cholesterol in the blood is a part of a package called HDL-cholesterol is carried in. HDL-cholesterol prevents the accumulation of cholesterol in the veins.
It collects the cholesterol circulating in the blood and brings it to the liver to get rid of it from the body. Thus, it reduces the exposure of blood vessels to the harmful effects of cholesterol. All these effects of HDL cholesterol in the paraoxonase enzyme owes. This may be the reason why Dolat may even use another nomenclature instead of HDL in future years. A paraoxonase-1 enzyme, which is known to decrease blood level with age, is found to be significantly lower in patients with myocardial infarction at a young age compared with the healthy control group in this study, and the measurement of this enzyme level can be used as a screening test in people with risk factors.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paraoxanase | – | Diagnostic Test: paraoxanase enzyme levelEnzyme level |
| Myocardial infarction | – | Diagnostic Test: paraoxanase enzyme levelRESULTS OF ANGIOGRAPHY |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the emergency department over the age of 18
Key inclusion criteria (2 listed)
- Those over the age of 18
- All acute coronary syndrome patients
Key exclusion criteria (1 listed)
- Patients with normal angiography
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 |
|---|---|---|
| paraoxanase enzyme levelAlso: troponin level, HDL levelpresence of paraoxonase enzyme deficiency and associated troponin elevation | Diagnostic test | Myocardial infarction, paraoxanase |
Primary outcome
early diagnosis
Time frame: one year
paraoxonase enzyme measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Individual participant dataSharing planned: No. nope
Related trials for Myocardial Infarction
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ST-Elevation Myocardial Infarction (STEMI)
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Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
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Cardiogenic Shock Working Group Registry
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Breisgau PHENO-HEART MI
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Not yet recruitingPhase 2
Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
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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.
bahadir taslidere principal investigator
BEZMİALEM VAKİF UNİVERSİTY
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 and High-Density Lipoid Deficiency, run by Bezmialem Vakif 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 31 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early diagnosis (time frame: one year). 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 31 May 2022.