Acute Coronary SyndromeNCT03830138
Oxidized LDL With Oxygen Therapy in Acute Coronary Syndrome.
An observational study of Acute Coronary Syndrome, run by Assiut University.
Trial summary
Coronary artery disease (CAD) is increasing rapidly in Egyptian people and manifesting a younger age. Higher plasma low-density lipoprotein cholesterol (LDL-C), is a major predictor for the development of CAD. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Oxidized-LDL gene polymorphism
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2019to 1 May 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Acute coronary syndrome patients
Who may be able to join
- Patients were included irrespective of concomitant risk factors for atherosclerosis such as smoking, arterial hypertension and diabetes mellitus.
- Participants were both sexes.
Who cannot join
- Congenital heart disease.
- Dilated, hypertrophic or restrictive cardiomyopathy.
- acute and chronic liver disorders.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Oxidized LDL, Oxidized LDL Receptor 1 (OLR1) Gene Polymorphism With Oxygen Therapy in Acute Myocardial Infarction.
Coronary artery disease (CAD) is increasing rapidly in Egyptian people and manifesting a younger age. Higher plasma low-density lipoprotein cholesterol (LDL-C), is a major predictor for the development of CAD. However, whether oxidized-LDL (ox-LDL) can be used as a risk factor for myocardial infarction (MI) has not been fully investigated. Therefore, the aim of the present study was to examine the role of ox-LDL as a risk factor for the presence and clinical outcomes in patients with MI.
Read the detailed description
Cardiovascular disease, which is multifactorial and caused by complex interactions of genetic and environmental factors, represents the main cause of death all over the world. Traditional risk factors for coronary atherosclerosis include age, smoking, male gender, hypertension and diabetes. Newly defined risk factors such as hyper-homocysteine, elevated plasma levels of OxLDL and oxidative stress are also emerging.
Lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1) is the major receptor of oxidized low-density lipoproteins which regulates the growth of a variety of cells and is important in inflammation, atherosclerosis, oxidative stress, and tissue remodeling. LOX-1 is expressed in various cells, including endothelial cells, macrophages, and chondrocytes, and its expression is enhanced by proinflammatory cytokines. The LOX1 gene, also known as OLR1, is located on the chromosome 12p13.1-p12.3. The LOX1 protein is synthesized as a 40-kDa precursor protein and is composed of four domains: an extracellular lectin-like domain at the C-terminal, a connecting neck domain, a transmembrane domain, and an N-terminal cytoplasmic domain. Three single nucleotide polymorphism (SNPs), namely, intron 4 (G→A), intron 5(T→G), and 3' UTR (T→C) in the LOX1 gene, have been previously reported. These polymorphisms have also been associated with CAD.
Oxygen is a lifesaving drug. Giving oxygen to a patient with an impending clinical emergency has become knee-jerk reflex reaction of the clinician. Patient with AMI has compromised myocardial perfusion and event arises due to myocardial hypoxia. It appears quite logical and biologically plausible to give oxygen in such situations to improve the oxygenation of the ischemic myocardial tissue and decrease ischemic pain. On the other side, oxygen may be harmful with a mechanism such as the paradoxical effect of oxygen in decreasing coronary artery blood flow and increasing coronary vascular resistance due to increased oxygen free radicals. The investigators aimed to examine the association of the OLR1 gene with AMI or CAD in a novel, well-phenotyped, and homogenous, population and its correlation with oxygen therapy in these patients.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Oxidized-LDL gene polymorphism
- Keywords
- Oxidized-LDL, OLR1 gene, Single nucleotide polymorphism, Oxygen therapy
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxidized-LDL gene polymorphismGenetic
Oxidized-LDL gene polymorphism will be measured by RFLP. In addition, Oxidized-LDL will be measured in the plasma by ELISA
| Study group | Role | What they receive |
|---|---|---|
| Acute coronary syndrome patients: | One hundred patients with acute coronary syndrome. Receives: Genetic: Oxidized-LDL gene polymorphism | |
| Controls: | Fifty healthy control Receives: Genetic: Oxidized-LDL gene polymorphism |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean difference of oxidized-LDL gene polymorphism between patients and controls
The mean difference of oxidized-LDL gene polymorphism will be assessed by RFLP. The change of single nucleotide polymorphism of oxidized-LDL from healthy controls at baseline
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start20 Feb 2019 (estimated)
- Primary completion1 Apr 2019 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham I El-mahdy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830138
- Sponsor's protocol ID
- Acute coronary syndrome
- Status last verified
- Feb 2019
- First submitted
- 1 Feb 2019
- Last updated
- 5 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ehara S, Ueda M, Naruko T, Haze K, Itoh A, Otsuka M, Komatsu R, Matsuo T, Itabe H, Takano T, Tsukamoto Y, Yoshiyama M, Takeuchi K, Yoshikawa J, Becker AE. Elevated levels of oxidized low density lipoprotein show a positive relationship with the severity of acute coronary syndromes. Circulation. 2001 Apr 17;103(15):1955-60. doi: 10.1161/01.cir.103.15.1955.
PubMed 11306523Trabetti E, Biscuola M, Cavallari U, Malerba G, Girelli D, Olivieri O, Martinelli N, Corrocher R, Pignatti PF. On the association of the oxidised LDL receptor 1 (OLR1) gene in patients with acute myocardial infarction or coronary artery disease. Eur J Hum Genet. 2006 Jan;14(1):127-30. doi: 10.1038/sj.ejhg.5201513.
PubMed 16251892Zhao X, Zhang HW, Xu RX, Guo YL, Zhu CG, Wu NQ, Gao Y, Li JJ. Oxidized-LDL is a useful marker for predicting the very early coronary artery disease and cardiovascular outcomes. Per Med. 2018 Nov;15(6):521-529. doi: 10.2217/pme-2018-0046. Epub 2018 Oct 26.
PubMed 30362886Raut MS, Maheshwari A. Oxygen supplementation in acute myocardial infarction: To be or not to be? Ann Card Anaesth. 2016 Apr-Jun;19(2):342-4. doi: 10.4103/0971-9784.179594. No abstract available.
PubMed 27052081
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidized LDL, Oxidized LDL Receptor 1 (OLR1) Gene Polymorphism With Oxygen Therapy in Acute Myocardial Infarction.
- ClinicalTrials.gov ID
- NCT03830138
- Acronym / sponsor ID
- Acute coronary syndrome
- Conditions
- Acute Coronary Syndrome
- Keywords
- Oxidized-LDL, OLR1 gene, Single nucleotide polymorphism, Oxygen therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Feb 2019 (estimated)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 5 Feb 2019 (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.
Coronary artery disease (CAD) is increasing rapidly in Egyptian people and manifesting a younger age. Higher plasma low-density lipoprotein cholesterol (LDL-C), is a major predictor for the development of CAD. However, whether oxidized-LDL (ox-LDL) can be used as a risk factor for myocardial infarction (MI) has not been fully investigated. Therefore, the aim of the present study was to examine the role of ox-LDL as a risk factor for the presence and clinical outcomes in patients with MI.
Detailed description
Cardiovascular disease, which is multifactorial and caused by complex interactions of genetic and environmental factors, represents the main cause of death all over the world. Traditional risk factors for coronary atherosclerosis include age, smoking, male gender, hypertension and diabetes. Newly defined risk factors such as hyper-homocysteine, elevated plasma levels of OxLDL and oxidative stress are also emerging.
Lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1) is the major receptor of oxidized low-density lipoproteins which regulates the growth of a variety of cells and is important in inflammation, atherosclerosis, oxidative stress, and tissue remodeling. LOX-1 is expressed in various cells, including endothelial cells, macrophages, and chondrocytes, and its expression is enhanced by proinflammatory cytokines. The LOX1 gene, also known as OLR1, is located on the chromosome 12p13.1-p12.3. The LOX1 protein is synthesized as a 40-kDa precursor protein and is composed of four domains: an extracellular lectin-like domain at the C-terminal, a connecting neck domain, a transmembrane domain, and an N-terminal cytoplasmic domain. Three single nucleotide polymorphism (SNPs), namely, intron 4 (G→A), intron 5(T→G), and 3' UTR (T→C) in the LOX1 gene, have been previously reported. These polymorphisms have also been associated with CAD.
Oxygen is a lifesaving drug. Giving oxygen to a patient with an impending clinical emergency has become knee-jerk reflex reaction of the clinician. Patient with AMI has compromised myocardial perfusion and event arises due to myocardial hypoxia. It appears quite logical and biologically plausible to give oxygen in such situations to improve the oxygenation of the ischemic myocardial tissue and decrease ischemic pain. On the other side, oxygen may be harmful with a mechanism such as the paradoxical effect of oxygen in decreasing coronary artery blood flow and increasing coronary vascular resistance due to increased oxygen free radicals. The investigators aimed to examine the association of the OLR1 gene with AMI or CAD in a novel, well-phenotyped, and homogenous, population and its correlation with oxygen therapy in these patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute coronary syndrome patients: | – | Genetic: Oxidized-LDL gene polymorphismOne hundred patients with acute coronary syndrome. |
| Controls: | – | Genetic: Oxidized-LDL gene polymorphismFifty healthy control |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Acute coronary syndrome patients
Key inclusion criteria (2 listed)
- Patients were included irrespective of concomitant risk factors for atherosclerosis such as smoking, arterial hypertension and diabetes mellitus.
- Participants were both sexes.
Key exclusion criteria (3 listed)
- Congenital heart disease.
- Dilated, hypertrophic or restrictive cardiomyopathy.
- acute and chronic liver disorders.
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 |
|---|---|---|
| Oxidized-LDL gene polymorphismOxidized-LDL gene polymorphism will be measured by RFLP. In addition, Oxidized-LDL will be measured in the plasma by ELISA | Genetic | Acute coronary syndrome patients:, Controls: |
Primary outcome
The mean difference of oxidized-LDL gene polymorphism between patients and controls
Time frame: Baseline
The mean difference of oxidized-LDL gene polymorphism will be assessed by RFLP. The change of single nucleotide polymorphism of oxidized-LDL from healthy controls at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Background: PubMed 11306523Ehara S, Ueda M, Naruko T, Haze K, Itoh A, Otsuka M, Komatsu R, Matsuo T, Itabe H, Takano T, Tsukamoto Y, Yoshiyama M, Takeuchi K, Yoshikawa J, Becker AE. Elevated levels of oxidized low density lipoprotein show a positive relationship with the severity of acute coronary syndromes. Circulation. 2001 Apr 17;103(15):1955-60. doi: 10.1161/01.cir.103.15.1955.
- Background: PubMed 16251892Trabetti E, Biscuola M, Cavallari U, Malerba G, Girelli D, Olivieri O, Martinelli N, Corrocher R, Pignatti PF. On the association of the oxidised LDL receptor 1 (OLR1) gene in patients with acute myocardial infarction or coronary artery disease. Eur J Hum Genet. 2006 Jan;14(1):127-30. doi: 10.1038/sj.ejhg.5201513.
- Background: PubMed 30362886Zhao X, Zhang HW, Xu RX, Guo YL, Zhu CG, Wu NQ, Gao Y, Li JJ. Oxidized-LDL is a useful marker for predicting the very early coronary artery disease and cardiovascular outcomes. Per Med. 2018 Nov;15(6):521-529. doi: 10.2217/pme-2018-0046. Epub 2018 Oct 26.
- Background: PubMed 27052081Raut MS, Maheshwari A. Oxygen supplementation in acute myocardial infarction: To be or not to be? Ann Card Anaesth. 2016 Apr-Jun;19(2):342-4. doi: 10.4103/0971-9784.179594. No abstract available.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Assiut University.
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 3 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 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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 reham elmahdy (+201002714637, reham.elmahdy@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean difference of oxidized-LDL gene polymorphism between patients and controls (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03830138, which also lists 4 linked publications.
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 5 Feb 2019.