Ischemic Heart DiseaseNCT04977089
Study of Lipid Profile of Patients With Chronic Coronary Syndromes at Sohag University Hospital
An observational study of Ischemic Heart Disease and Dyslipidemias, run by Sohag University at 1 site in Egypt.
Trial summary
Chronic coronary syndrome (CCS) is a newly described classification devised by the European Society of Cardiology (ESC) 2019 to replace the term "Stable Coronary Artery Disease (CAD). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Heart Disease, Dyslipidemias
- What is being tested?
- lipid profile test .
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2020to 1 Aug 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: I examine cross sectional study which classify 100 patients with chronic coronary syndrome into: two main groups : * patient on statin therapy. * patient not on statin therapy. _And determine if patints in sohag university hospital could achive the target lipid profile level of their group according to 2019 ESC/EAS Guidelines for the management of dyslipidaemia. I classify 100 patients with chronic coronary syndrome into: two main groups : * patient on statin therapy. * patient not on statin therapy. _And determine if patints in sohag university hospital could achive the target lipid profile level of their group according to 2019 ESC/EAS Guidelines for the management of dyslipidaemia.
Who may be able to join
- All patients have chronic coronary disease at Sohag University hospital who recieve drugs of anti hyperlipidemia .
Who cannot join
- Patients with first attack of acute coronary syndrome .
- Young patients <18 years .
- Old patients >65 years.
Trial locations and contacts
1 site in 1 country.
Ali M Ahmed, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Osama R ElSherif, professor
About this study
Chronic coronary syndrome (CCS) is a newly described classification devised by the European Society of Cardiology (ESC) 2019 to replace the term "Stable Coronary Artery Disease (CAD).
The main reason for effecting the change is the term is thought to better describe the disease process and encompass a wider spectrum of clinical, pharmacological, and pathophysiological entities.
Read more
Using this new term, the disease atherosclerosis manifests as CAD is categorized into Acute Coronary Syndrome (ACS) and CCS.
The main focus of introducing the concept of CCS is on the fact that CAD is a continuous phenomenon involving intravascular plaque aggregation and progression which has different evolutionary phases.
Dyslipidemia is recognized as a prominent risk factor for cardiovascular (CV) disease.
It is characterized by an elevation of serum total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), or triglycerides (TG) and reduced serum high-density lipoprotein cholesterol (HDL-C) concentration .
Genetically determined and metabolically induced disturbances in lipid metabolism, as manifested in several types of dyslipidemia, have been shown to be causally related to the development of coronary artery disease (CAD).
A diversity of clinical and angiographic studies has been made to evaluate the linkage between plasma lipid-control therapy in the development of recurrent cardiovascular events.
Independent predictors of recurrent CVD events or death include age, smoking, hypertension (HTN), dyslipidemia, diabetes mellitus, chronic kidney disease, and the underutilization of medications recommended by current treatment guidelines.
- Conditions
- Ischemic Heart Disease, Dyslipidemias
- Being tested
- lipid profile test .
- Medical subject headings
- Myocardial Ischemia, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lipid profile test .Diagnostic test
Assesment of lipid profile of patients (cholesterol level ,TG ,VLDL )
| Study group | Role | What they receive |
|---|---|---|
| Ischemic heart disease patients . | Study of lipid profile of patients with chronic coronary syndromes who recieve drugs of anti hyperlipidemia at the cardiology clinic of sohag university hospital. Receives: Diagnostic Test: lipid profile test . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyslipidemia in chronic coronary syndrome
Pattern of dyslipidemia among patients with chronic coronary syndromes at sohag university hospital.
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 posted26 Jul 2021
- Study start1 Aug 2020
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Mohamed Farrag, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977089
- Sponsor's protocol ID
- Soh-Med-21-07-01
- Status last verified
- Jul 2021
- First submitted
- 14 Jul 2021
- Last updated
- 26 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Darroudi S, Saberi-Karimian M, Tayefi M, Arekhi S, Motamedzadeh Torghabeh A, Seyedzadeh Sani SMR, Moohebati M, Heidari-Bakavoli A, Ebrahimi M, Azarpajouh MR, Safarian M, A Ferns G, Esmaeili H, Parizadeh MR, Mokhber N, Mahdizadeh A, Mahmoudi AA, Sahebkar AH, Ghayour-Mobarhan M. Prevalence of combined and noncombined dyslipidemia in an Iranian population. J Clin Lab Anal. 2018 Oct;32(8):e22579. doi: 10.1002/jcla.22579. Epub 2018 Jun 21.
PubMed 29926995Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available.
PubMed 31504439Mortensen MB, Falk E, Li D, Nasir K, Blaha MJ, Sandfort V, Rodriguez CJ, Ouyang P, Budoff M. Statin Trials, Cardiovascular Events, and Coronary Artery Calcification: Implications for a Trial-Based Approach to Statin Therapy in MESA. JACC Cardiovasc Imaging. 2018 Feb;11(2 Pt 1):221-230. doi: 10.1016/j.jcmg.2017.01.029. Epub 2017 Jul 25.
PubMed 28624395
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Lipid Profile of Patients With Chronic Coronary Syndromes at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT04977089
- Acronym / sponsor ID
- Soh-Med-21-07-01
- Conditions
- Ischemic Heart Disease, Dyslipidemias
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 26 Jul 2021 (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.
Chronic coronary syndrome (CCS) is a newly described classification devised by the European Society of Cardiology (ESC) 2019 to replace the term "Stable Coronary Artery Disease (CAD).
The main reason for effecting the change is the term is thought to better describe the disease process and encompass a wider spectrum of clinical, pharmacological, and pathophysiological entities.
Using this new term, the disease atherosclerosis manifests as CAD is categorized into Acute Coronary Syndrome (ACS) and CCS.
The main focus of introducing the concept of CCS is on the fact that CAD is a continuous phenomenon involving intravascular plaque aggregation and progression which has different evolutionary phases.
Dyslipidemia is recognized as a prominent risk factor for cardiovascular (CV) disease.
It is characterized by an elevation of serum total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), or triglycerides (TG) and reduced serum high-density lipoprotein cholesterol (HDL-C) concentration .
Genetically determined and metabolically induced disturbances in lipid metabolism, as manifested in several types of dyslipidemia, have been shown to be causally related to the development of coronary artery disease (CAD).
A diversity of clinical and angiographic studies has been made to evaluate the linkage between plasma lipid-control therapy in the development of recurrent cardiovascular events.
Independent predictors of recurrent CVD events or death include age, smoking, hypertension (HTN), dyslipidemia, diabetes mellitus, chronic kidney disease, and the underutilization of medications recommended by current treatment guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ischemic heart disease patients . | – | Diagnostic Test: lipid profile test .Study of lipid profile of patients with chronic coronary syndromes who recieve drugs of anti hyperlipidemia at the cardiology clinic of sohag university hospital. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- I examine cross sectional study which classify 100 patients with chronic coronary syndrome into: two main groups : * patient on statin therapy. * patient not on statin therapy. _And determine if patints in sohag university hospital could achive the target lipid profile level of their group according to 2019 ESC/EAS Guidelines for the management of dyslipidaemia. I classify 100 patients with chronic coronary syndrome into: two main groups : * patient on statin therapy. * patient not on statin therapy. _And determine if patints in sohag university hospital could achive the target lipid profile level of their group according to 2019 ESC/EAS Guidelines for the management of dyslipidaemia.
Key inclusion criteria (1 listed)
- All patients have chronic coronary disease at Sohag University hospital who recieve drugs of anti hyperlipidemia .
Key exclusion criteria (3 listed)
- Patients with first attack of acute coronary syndrome .
- Young patients <18 years .
- Old patients >65 years.
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 |
|---|---|---|
| lipid profile test .Assesment of lipid profile of patients (cholesterol level ,TG ,VLDL ) | Diagnostic test | Ischemic heart disease patients . |
Primary outcome
Dyslipidemia in chronic coronary syndrome
Time frame: one year
Pattern of dyslipidemia among patients with chronic coronary syndromes at sohag university hospital.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Background: PubMed 29926995Darroudi S, Saberi-Karimian M, Tayefi M, Arekhi S, Motamedzadeh Torghabeh A, Seyedzadeh Sani SMR, Moohebati M, Heidari-Bakavoli A, Ebrahimi M, Azarpajouh MR, Safarian M, A Ferns G, Esmaeili H, Parizadeh MR, Mokhber N, Mahdizadeh A, Mahmoudi AA, Sahebkar AH, Ghayour-Mobarhan M. Prevalence of combined and noncombined dyslipidemia in an Iranian population. J Clin Lab Anal. 2018 Oct;32(8):e22579. doi: 10.1002/jcla.22579. Epub 2018 Jun 21.
- Background: PubMed 31504439Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available.
- Background: PubMed 28624395Mortensen MB, Falk E, Li D, Nasir K, Blaha MJ, Sandfort V, Rodriguez CJ, Ouyang P, Budoff M. Statin Trials, Cardiovascular Events, and Coronary Artery Calcification: Implications for a Trial-Based Approach to Statin Therapy in MESA. JACC Cardiovasc Imaging. 2018 Feb;11(2 Pt 1):221-230. doi: 10.1016/j.jcmg.2017.01.029. Epub 2017 Jul 25.
- Individual participant dataSharing planned: Yes
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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.
Ali M Ahmed, professor contact
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 Ischemic Heart Disease and Dyslipidemias, run by Sohag University at 1 site in Egypt.
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 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 26 Jul 2021. 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 Egypt. 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 Islam M Farrag, resident (01092029333, islam010011@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyslipidemia in chronic coronary syndrome (time frame: one year). 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 NCT04977089, which also lists 3 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 26 Jul 2021.