Anterior STEMISTEMINCT04572191
Ceramide Level as Apredictor of Outcomes in Patients of Anterior Myocardial Infarction Undergoing Primary Coronary Intervention
An observational study of Anterior STEMI, run by Assiut University at 1 site in Egypt.
Trial summary
Ceramide level as a predictor of outcomes in patients of anterior myocardial infarction undergoing primary Coronary intervention Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anterior STEMI
- What is being tested?
- CERAMIDE LEVEL IN BLOOD
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2020to 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ALL PATIENTS COMPLAING OF ANTERIOR STEMI \& UNDERENTPRIMARY PCI
Who may be able to join
- 1- Subjects with anterior STEMI according to ESC guidelines 2017 . 2. Subjects undergoing PPCI
Who cannot join
- Patients with previous PCI. Patients with previous CABG. Patients with TIMI flow less than II. Patients with residual stenosis more than 70 % in major artery. Cardiogenic shock.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Esraa Sayed Hamed
Asyut, 23123
salwa Rushdy, professor, 01223971267, Salwademitry@yahoo.com
mohamed abdel - ghani, professor, 01025880990, m-koriem2004@yahoo.com
About this study
Ceramide level as a predictor of outcomes in patients of anterior myocardial infarction undergoing primary Coronary intervention
Read the detailed description
Ceramides are a family of lipid molecules that are found in high concentrations within cell membranes and play a key role in a variety of physiological functions including apoptosis, cell growth, cell adhesion and plasma membrane integrity maintenance.(1)
All tissues can synthesize ceramides de novo from saturated fats and sphingosine.(2) the ( LDL ) Present in atherosclerotic plaque is rich in ceramide and contain 10 - 50 fold higher content of ceramide when compared with plasma LDL .(3)
Ceramide (d18:1/16:0) is associated with the fraction of necrotic core tissue and lipid core burden in coronary atherosclerosis.(4) Previous clinical research found that circulating ceramides are elevated in patients with hypertension,(5) obesity (6 - 7) and type II diabetes mellitus.
Previous clinical research found that elevated ceramide plasma concentrations are associated with coronary plaque vulnerability evaluated by intravascular ultrasound .
virtual Recent studies showed targeted profiling of ceramides predicted short-term and long-term major adverse cardiac events.
Plasma ceramide level is also positively associated with the levels of total cholesterol. [8 - 9] The plasma ceramides that have been studied as high-risk factors are Cer (d18:1/16:0), Cer (d18:1/18:0) and Cer (d18:1/24:1) and the ratios of these ceramides to Cer (d18:1/24:0) [10 - 11].
However, it is tempting to speculate that ceramides are associated with plaque vulnerability as they are known to fuel many central atherosclerosis processes including lipoprotein aggregation and uptake, inflammation, superoxide anion production, andapoptosis 12 - 13 - 14
- Conditions
- Anterior STEMI
- Being tested
- CERAMIDE LEVEL IN BLOOD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CERAMIDE LEVEL IN BLOODDiagnostic test
BY ELISA ASSAY TO DETECT CERAMIDE LEVEL IN BLOOD IN ANTERIOR STEMI PATIENTS
What is being measured
The primary outcome is the main question the study is designed to answer.
to detect early & mid -term MACE complication in anterior STEMI patients undergoing PPCI & their relation with ceramide level in these patients
to detect early \& mid -term MACE complication in anterior STEMI patients undergoing PPCI \& their relation with ceramide level in these patients
Measured: BASELINE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study startSep 2020 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionOct 2021 (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 Anterior STEMIStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, esraa sayed hamed Ahmed, Assiut University
- Investigators
- mohamed abdel - ghani, professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572191
- Sponsor's protocol ID
- anterior STEMI
- Acronym
- STEMI
- Status last verified
- Sep 2020
- First submitted
- 27 Sep 2020
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tu C, Xie L, Wang Z, Zhang L, Wu H, Ni W, Li C, Li L, Zeng Y. Association between ceramides and coronary artery stenosis in patients with coronary artery disease. Lipids Health Dis. 2020 Jun 25;19(1):151. doi: 10.1186/s12944-020-01329-0.
PubMed 32586390Pan W, Li L, Sun M, Wang C, Fang S, Yu B. Plasma ceramides are associated with coronary atherosclerotic burden in patients with ST-segment elevation myocardial infarction. Int J Cardiol. 2020 Dec 1;320:155-160. doi: 10.1016/j.ijcard.2020.08.010. Epub 2020 Aug 12.
PubMed 32800902Mantovani A, Bonapace S, Lunardi G, Canali G, Dugo C, Vinco G, Calabria S, Barbieri E, Laaksonen R, Bonnet F, Byrne CD, Targher G. Associations between specific plasma ceramides and severity of coronary-artery stenosis assessed by coronary angiography. Diabetes Metab. 2020 Apr;46(2):150-157. doi: 10.1016/j.diabet.2019.07.006. Epub 2019 Aug 3.
PubMed 31386900Tu CC, Wan BY, Zhao XL, Li CX, Wu HM, Zhang LL, Li L, Zeng Y. [Value of ceramide in the diagnosis and risk prediction of coronary artery disease]. Zhonghua Yi Xue Za Zhi. 2019 Oct 22;99(39):3089-3092. doi: 10.3760/cma.j.issn.0376-2491.2019.39.010. Chinese.
PubMed 31648453
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ceramide Level as Apredictor of Outcomes in Patients of Anterior Myocardial Infarction Undergoing Primary Coronary Intervention
- ClinicalTrials.gov ID
- NCT04572191
- Acronym / sponsor ID
- STEMI / anterior STEMI
- Conditions
- Anterior STEMI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 1 Oct 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.
Ceramide level as a predictor of outcomes in patients of anterior myocardial infarction undergoing primary Coronary intervention
Detailed description
Ceramides are a family of lipid molecules that are found in high concentrations within cell membranes and play a key role in a variety of physiological functions including apoptosis, cell growth, cell adhesion and plasma membrane integrity maintenance.(1)
All tissues can synthesize ceramides de novo from saturated fats and sphingosine.(2) the ( LDL ) Present in atherosclerotic plaque is rich in ceramide and contain 10 - 50 fold higher content of ceramide when compared with plasma LDL .(3)
Ceramide (d18:1/16:0) is associated with the fraction of necrotic core tissue and lipid core burden in coronary atherosclerosis.(4) Previous clinical research found that circulating ceramides are elevated in patients with hypertension,(5) obesity (6 - 7) and type II diabetes mellitus.
Previous clinical research found that elevated ceramide plasma concentrations are associated with coronary plaque vulnerability evaluated by intravascular ultrasound .
virtual Recent studies showed targeted profiling of ceramides predicted short-term and long-term major adverse cardiac events.
Plasma ceramide level is also positively associated with the levels of total cholesterol. [8 - 9] The plasma ceramides that have been studied as high-risk factors are Cer (d18:1/16:0), Cer (d18:1/18:0) and Cer (d18:1/24:1) and the ratios of these ceramides to Cer (d18:1/24:0) [10 - 11].
However, it is tempting to speculate that ceramides are associated with plaque vulnerability as they are known to fuel many central atherosclerosis processes including lipoprotein aggregation and uptake, inflammation, superoxide anion production, andapoptosis 12 - 13 - 14
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ALL PATIENTS COMPLAING OF ANTERIOR STEMI \& UNDERENTPRIMARY PCI
Key inclusion criteria (1 listed)
- 1- Subjects with anterior STEMI according to ESC guidelines 2017 . 2. Subjects undergoing PPCI
Key exclusion criteria (1 listed)
- Patients with previous PCI. Patients with previous CABG. Patients with TIMI flow less than II. Patients with residual stenosis more than 70 % in major artery. Cardiogenic shock.
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 |
|---|---|---|
| CERAMIDE LEVEL IN BLOODBY ELISA ASSAY TO DETECT CERAMIDE LEVEL IN BLOOD IN ANTERIOR STEMI PATIENTS | Diagnostic test | – |
Primary outcome
to detect early & mid -term MACE complication in anterior STEMI patients undergoing PPCI & their relation with ceramide level in these patients
Time frame: BASELINE
to detect early \& mid -term MACE complication in anterior STEMI patients undergoing PPCI \& their relation with ceramide level in these patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Background: PubMed 32586390Tu C, Xie L, Wang Z, Zhang L, Wu H, Ni W, Li C, Li L, Zeng Y. Association between ceramides and coronary artery stenosis in patients with coronary artery disease. Lipids Health Dis. 2020 Jun 25;19(1):151. doi: 10.1186/s12944-020-01329-0.
- Background: PubMed 32800902Pan W, Li L, Sun M, Wang C, Fang S, Yu B. Plasma ceramides are associated with coronary atherosclerotic burden in patients with ST-segment elevation myocardial infarction. Int J Cardiol. 2020 Dec 1;320:155-160. doi: 10.1016/j.ijcard.2020.08.010. Epub 2020 Aug 12.
- Background: PubMed 31386900Mantovani A, Bonapace S, Lunardi G, Canali G, Dugo C, Vinco G, Calabria S, Barbieri E, Laaksonen R, Bonnet F, Byrne CD, Targher G. Associations between specific plasma ceramides and severity of coronary-artery stenosis assessed by coronary angiography. Diabetes Metab. 2020 Apr;46(2):150-157. doi: 10.1016/j.diabet.2019.07.006. Epub 2019 Aug 3.
- Background: PubMed 31648453Tu CC, Wan BY, Zhao XL, Li CX, Wu HM, Zhang LL, Li L, Zeng Y. [Value of ceramide in the diagnosis and risk prediction of coronary artery disease]. Zhonghua Yi Xue Za Zhi. 2019 Oct 22;99(39):3089-3092. doi: 10.3760/cma.j.issn.0376-2491.2019.39.010. Chinese.
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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.
mohamed abdel - ghani, professor principal investigator
Assiut 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 Anterior STEMI, run by Assiut 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 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: status not confirmed, as of the sponsor's last update on 1 Oct 2020. 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 esraa RESIDENT sayed (01060558484, esraa.sayed3369@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to detect early & mid -term MACE complication in anterior STEMI patients undergoing PPCI & their relation with ceramide level in these patients (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 NCT04572191, 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 1 Oct 2020.