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

September 27, 2020 updated by: esraa sayed hamed Ahmed, Assiut University
Ceramide level as a predictor of outcomes in patients of anterior myocardial infarction undergoing primary Coronary intervention

Study Overview

Status

Unknown

Conditions

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

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

ALL PATIENTS COMPLAING OF ANTERIOR STEMI & UNDERENTPRIMARY PCI

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
BASELINE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: mohamed abdel - ghani, professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2020

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

September 27, 2020

First Submitted That Met QC Criteria

September 27, 2020

First Posted (Actual)

October 1, 2020

Study Record Updates

Last Update Posted (Actual)

October 1, 2020

Last Update Submitted That Met QC Criteria

September 27, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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