Acute Coronary SyndromeNCT04951401
Pattern of Dyslipidemia Among Patients With Acute Coronary Syndrome at Sohag University Hospital
An observational study of Acute Coronary Syndrome, run by Sohag University at 1 site in Egypt.
Trial summary
In this study, I am aime to analyze lipid profile in patients with ACS who presents at sohag university hospital, and its clinical and complications pattern. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- lipid profile and ECG
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 31 Oct 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: about 100 adult patients will be included in this study aged above 18 years old diagnosed acute coronary syndrome
Who may be able to join
- clinical diagnosed Acute coronary syndromes
- -
Who cannot join
- chronic coronary syndrome
Trial locations and contacts
1 site in 1 country.
About this study
In this study, I am aime to analyze lipid profile in patients with ACS who presents at sohag university hospital, and its clinical and complications pattern.
Read the detailed description
Coronary artery disease (CAD) is the most important cause of death in men and women The great majority of ACS patients have at least one major risk factor.
Acute Coronary Syndrome (ACS) is a major reason for Coronary Care Unit ( CCU )sohag university hospital admission The risk of CAD was about 4 and 3 times higher in male and female smokers than nonsmokers respectively (Baba S et. al ; 2006) Dyslipidemia has been identified as one of most important modifiable risk factor for CAD . Treating dyslipidemia has clear benefits in the primary and secondary prevention of coronary heart disease (CHD) in both sexes . This study focused on dyslipidemia as a risk factor of acute coronary syndrome (ACS).
- Conditions
- Acute Coronary Syndrome
- Being tested
- lipid profile, ECG
- 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.
lipid profileOther
lipid profile
ECGOther
ECG
| Study group | Role | What they receive |
|---|---|---|
| Normal & abnormal lipid parameters value | parameters value among normal and abnormal lipid profile Receives: Other: lipid profile; Other: ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
dyslipiemia in acute coronary syndrome
pattern of dyslipidemia among patients with acute coronary syndrome 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 posted6 Jul 2021
- Study start1 Aug 2021
- Primary completion1 Oct 2021
- Study completion31 Oct 2021
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 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
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Mostafa Abdelfattah, Sohag University
- Investigators
- esraa m abdelfatah, resident, Principal investigator, esraa m abdelfatah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951401
- Sponsor's protocol ID
- soh-Med-21-06-06
- Status last verified
- Feb 2022
- First submitted
- 18 Jun 2021
- Last updated
- 16 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: dyslipidemia at acute coronary syndrome
Publications
Graichen C, Tanner C. Diagnosis of Acute Coronary Syndrome. Am Fam Physician. 2018 Aug 1;98(3):Online. No abstract available.
PubMed 30215890Dali B. Clinical Profile, Dyslipidemia and ACS - a Correlation. JNMA J Nepal Med Assoc. 2014 Jul-Sep;52(195):907-13.
PubMed 26982665Ray KK, Ditmarsch M, Kallend D, Niesor EJ, Suchankova G, Upmanyu R, Anzures-Cabrera J, Lehnert V, Pauly-Evers M, Holme I, Stasek J, van Hessen MW, Jones P; dal-ACUTE Investigators. The effect of cholesteryl ester transfer protein inhibition on lipids, lipoproteins, and markers of HDL function after an acute coronary syndrome: the dal-ACUTE randomized trial. Eur Heart J. 2014 Jul 14;35(27):1792-800. doi: 10.1093/eurheartj/ehu105. Epub 2014 Mar 17.
PubMed 24639426Eisen A, Giugliano RP, Braunwald E. Updates on Acute Coronary Syndrome: A Review. JAMA Cardiol. 2016 Sep 1;1(6):718-30. doi: 10.1001/jamacardio.2016.2049.
PubMed 27438381
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Dyslipidemia Among Patients With Acute Coronary Syndrome at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT04951401
- Acronym / sponsor ID
- soh-Med-21-06-06
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 6 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.
In this study, I am aime to analyze lipid profile in patients with ACS who presents at sohag university hospital, and its clinical and complications pattern.
Detailed description
Coronary artery disease (CAD) is the most important cause of death in men and women The great majority of ACS patients have at least one major risk factor.
Acute Coronary Syndrome (ACS) is a major reason for Coronary Care Unit ( CCU )sohag university hospital admission The risk of CAD was about 4 and 3 times higher in male and female smokers than nonsmokers respectively (Baba S et. al ; 2006) Dyslipidemia has been identified as one of most important modifiable risk factor for CAD . Treating dyslipidemia has clear benefits in the primary and secondary prevention of coronary heart disease (CHD) in both sexes . This study focused on dyslipidemia as a risk factor of acute coronary syndrome (ACS).
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal & abnormal lipid parameters value | – | Other: lipid profile, Other: ECGparameters value among normal and abnormal lipid profile |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- about 100 adult patients will be included in this study aged above 18 years old diagnosed acute coronary syndrome
Key inclusion criteria (2 listed)
- clinical diagnosed Acute coronary syndromes
- -
Key exclusion criteria (1 listed)
- chronic coronary syndrome
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 profilelipid profile | Other | Normal & abnormal lipid parameters value |
| ECGECG | Other | Normal & abnormal lipid parameters value |
Primary outcome
dyslipiemia in acute coronary syndrome
Time frame: one year
pattern of dyslipidemia among patients with acute coronary syndrome at sohag university hospital
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 16 Feb 2022.
- Background: PubMed 30215890Graichen C, Tanner C. Diagnosis of Acute Coronary Syndrome. Am Fam Physician. 2018 Aug 1;98(3):Online. No abstract available.
- Background: PubMed 26982665Dali B. Clinical Profile, Dyslipidemia and ACS - a Correlation. JNMA J Nepal Med Assoc. 2014 Jul-Sep;52(195):907-13.
- Results publication: PubMed 24639426Ray KK, Ditmarsch M, Kallend D, Niesor EJ, Suchankova G, Upmanyu R, Anzures-Cabrera J, Lehnert V, Pauly-Evers M, Holme I, Stasek J, van Hessen MW, Jones P; dal-ACUTE Investigators. The effect of cholesteryl ester transfer protein inhibition on lipids, lipoproteins, and markers of HDL function after an acute coronary syndrome: the dal-ACUTE randomized trial. Eur Heart J. 2014 Jul 14;35(27):1792-800. doi: 10.1093/eurheartj/ehu105. Epub 2014 Mar 17.
- Results publication: PubMed 27438381Eisen A, Giugliano RP, Braunwald E. Updates on Acute Coronary Syndrome: A Review. JAMA Cardiol. 2016 Sep 1;1(6):718-30. doi: 10.1001/jamacardio.2016.2049.
- Individual participant dataSharing planned: No. dyslipidemia at acute coronary syndrome
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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.
esraa m abdelfatah, resident principal investigator
esraa m abdelfatah
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 Acute Coronary Syndrome, 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 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 16 Feb 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 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?
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?
dyslipiemia in acute 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 NCT04951401, 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 16 Feb 2022.