Ceramide Level as Apredictor of Outcomes in Patients of Anterior Myocardial Infarction Undergoing Primary Coronary Intervention

Anterior STEMI Clinical Trial

— STEMI  

Official title:

Ceramide Level as Apredictor of Outcomes in Patients of Anterior Myocardial Infarction Undergoing Primary Coronary Intervention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04572191
• Other study ID #: anterior STEMI
• Status: Not yet recruiting
• Start date: September 2020
• Est. completion date: October 2021

Study information

• Verified date: September 2020
• Source: Assiut University
• Contact: esraa RESIDENT sayed
• Phone: 01060558484
• Email: esraa.sayed3369[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Ceramide level as a predictor of outcomes in patients of anterior myocardial infarction undergoing primary Coronary intervention

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior STEMI
• Anterior Wall Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Diagnostic Test:
• CERAMIDE LEVEL IN BLOOD
BY ELISA ASSAY TO DETECT CERAMIDE LEVEL IN BLOOD IN ANTERIOR STEMI PATIENTS

Locations

Country	Name	City	State
Egypt	Esraa Sayed Hamed	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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 Aug 12. pii: S0167-5273(20)33537-3. doi: 10.1016/j.ijcard.2020.08.010. [Epub ahead of print] — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	BASELINE