Postprandial Triglyceride Impact on Coronary Atherosclerosis in Non-Diabetic Patient in Sohag University Hospital

NCT06501287 | Recruiting

• 1 other identifier: Soh-Med-24-04-02Ms
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

INTRODUCTION Cardiovascular diseases, including coronary artery disease (CAD), are the leading cause of mortality worldwide. Despite remarkable advancements in diagnostic and therapeutic approaches, CAD continues to pose formidable challenges. Atherosclerosis, characterized by the deposition of lipids, inflammatory cells, and fibrous tissue within the arterial walls, is the fundamental pathology underpinning CAD. Atherosclerosis development and progression are closely intertwined with lipid metabolism, particularly elevated levels of low-density lipoprotein cholesterol (LDL-C) and reduced levels of high-density lipoprotein cholesterol (HDL-C) \*1+. However, emerging evidence suggests that postprandial triglyceride levels, the transient increase in triglycerides following a meal, may play a pivotal role in atherosclerotic processes \*2+. Postprandial hypertriglyceridemia has been linked to various cardiovascular risk factors, including inflammation, endothelial dysfunction, oxidative stress, and altered hemostasis \*3+. cardiovascular disease (CVD) causes death for 4 million subjects in Europe every year. It causes death for women \*2.2 million (55%)+ than men \*1.8 million (45%)+, and cardiovascular (CV) deaths under 65 years more prevalent in men (490 000 versus 193 000) \*4+. Endothelial dysfunction was the main cause of vascular atherosclerosis. The damage of Endothelium cause lipids and macrophages accumulation (mostly lowdensity lipoprotein) in vessel injury site \*5+. Lipids considered the major cause of atherosclerosis \*6+. The increase of blood cholesterol (especially LDL) considered the main cause of the disease. High levels of triglycerides could be independent risk factor for coronary artery disease (CAD), particularly in women. Although, it was suggested that high level of density lipoproteins (HDLs) can prohibit these risk factors. Extensive examinations showed that lipid decrease the prevention of CAD in primary and secondary cases \*7+. The level \> 90% of total glyceride and/or LDL and level \> 10% of HDL confirm dyslipidemia \*8+

Conditions

Coronary Atheroscleroses

Outcome Measures

Primary Outcomes (1)

• impact of postprandial triglyceride level on coronary atherosclerosis in non diabetic patients

  impact of postprandial triglyceride concentration measured by chemistry analyzer on coronary atherosclerosis (assassed by plaque volume and luminal narrowing in coronary angiography )in non-diabetic patients

  7 months

Study Arms (3)

Group I (control group):

patients with normal coronary angiography and normal postprandial triglycerides

Diagnostic Test: Postprandial triglyceride

Group II

: patients with abnormal coronary angiography and high level of postprandial triglycerides more than 200mg/dl. They will be divided into subgroups according to severity of coronary artery disease (mild, moderate and severe) according to (Syntax score)

Diagnostic Test: Postprandial triglyceride

Group III

: patients with abnormal coronary angiography and normal postprandial triglycerides.

Diagnostic Test: Postprandial triglyceride

Interventions

Postprandial triglyceride DIAGNOSTIC_TEST

impact of postprandial triglyceride level on coronary atherosclerosis

Group I (control group):; Group II; Group III

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

includes CAD based on coronary angiography, laboratory and ECG evidence.

You may not qualify if:

• Patients with other co-morbidities diseases, such as liver and kidney disorders and thyroid diseases. Diabetic patients.

Sponsors & Collaborators

• Fatma Madhy Eissa: lead

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

• Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1082-e1143. doi: 10.1161/CIR.0000000000000625. Epub 2018 Nov 10.

  PMID: 30586774 BACKGROUND

• Nordestgaard BG, Benn M, Schnohr P, Tybjaerg-Hansen A. Nonfasting triglycerides and risk of myocardial infarction, ischemic heart disease, and death in men and women. JAMA. 2007 Jul 18;298(3):299-308. doi: 10.1001/jama.298.3.299.

  PMID: 17635890 BACKGROUND

• Tushuizen ME, Nieuwland R, Scheffer PG, Sturk A, Heine RJ, Diamant M. Two consecutive high-fat meals affect endothelial-dependent vasodilation, oxidative stress and cellular microparticles in healthy men. J Thromb Haemost. 2006 May;4(5):1003-10. doi: 10.1111/j.1538-7836.2006.01914.x.

  PMID: 16689751 BACKGROUND

• Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, Hoes AW, Jennings CS, Landmesser U, Pedersen TR, Reiner Z, Riccardi G, Taskinen MR, Tokgozoglu L, Verschuren WMM, Vlachopoulos C, Wood DA, Zamorano JL, Cooney MT; ESC Scientific Document Group. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. Eur Heart J. 2016 Oct 14;37(39):2999-3058. doi: 10.1093/eurheartj/ehw272. Epub 2016 Aug 27. No abstract available.

  PMID: 27567407 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Fatma M Eissa, resident

CONTACT

01150754924; fatma_mdhy_post@med.sohag.edu.eg

Ali M kassem, professor

CONTACT

01003459738

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: resident internal medecine

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: July 15, 2024
• Study Start: May 1, 2024
• Primary Completion: December 25, 2024
• Study Completion: December 25, 2024
• Last Updated: July 15, 2024

Record last verified: 2024-07

Locations

EG (1)