- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04572191
Ceramide Level as Apredictor of Outcomes in Patients of Anterior Myocardial Infarction Undergoing Primary Coronary Intervention (STEMI)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: esraa RESIDENT sayed
- Phone Number: 01060558484
- Email: esraa.sayed3369@gmail.com
Study Contact Backup
- Name: salwa Rushdy, professor
- Phone Number: 01223971267
- Email: Salwademitry@yahoo.com
Study Locations
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Assiut, Egypt, 23123
- Esraa Sayed Hamed
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Contact:
- salwa Rushdy, professor
- Phone Number: 01223971267
- Email: Salwademitry@yahoo.com
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Contact:
- mohamed abdel - ghani, professor
- Phone Number: 01025880990
- Email: m-koriem2004@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 1- Subjects with anterior STEMI according to ESC guidelines 2017 . 2. Subjects undergoing PPCI
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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BASELINE
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: mohamed abdel - ghani, professor, Assiut University
Publications and helpful links
General 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.
- Pan 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.
- Mantovani 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.
- Tu 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- anterior STEMI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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