NCT07154186

Brief Summary

This study aims to evaluate the impact of the triglyceride-glucose (TyG) index on the angiographic profiling of non-diabetic patients with premature coronary artery disease (CAD).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 4, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

September 4, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

September 5, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

August 27, 2025

Last Update Submit

September 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of ischemia- driven revascularization

    Incidence of ischemia- driven revascularization will be recorded.

    6 months post-procedure

Secondary Outcomes (4)

  • Association between triglyceride-glucose index and single-vessel disease

    6 months post-procedure

  • Association between triglyceride-glucose index and two-vessel disease

    6 months post-procedure

  • Association between triglyceride-glucose index and three-vessel disease

    6 months post-procedure

  • Correlation of the triglyceride-glucose index with traditional cardiovascular risk factor

    6 months post-procedure

Study Arms (2)

Group L

Patients with a low triglyceride-glucose (TyG) index tertile.

Other: Coronary Angiographic Assessment

Group H

Patients with a high triglyceride-glucose (TyG) index tertile.

Other: Coronary Angiographic Assessment

Interventions

Coronary angiographic assessment will be performed for all patients.

Group HGroup L

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This cross-sectional study will be conducted at Sohag University Hospitals, following approval from the institutional ethics committee.

You may qualify if:

  • Age ≥18 years old.
  • Both sexes.
  • Non-diabetic patients \[no history of diabetes, hemoglobin A1C (HbA1C) \< 6.5%, fasting glucose \< 126 mg/dL\].
  • Confirmed diagnosis of coronary artery disease (CAD) by coronary angiography.

You may not qualify if:

  • Known diabetes mellitus (type 1 or type 2).
  • Previous history of coronary revascularization.
  • Severe hepatic or renal dysfunction \[alanine transaminase (ALT)/aspartate aminotransferase (AST) ≥ 5× upper limit of normal (ULN), estimated glomerular filtration rate (eGFR)\< 30 mL/min/1.73 m²\].
  • Malignant disease, autoimmune disease, or systemic inflammatory disorders.
  • Current use of triglyceride-lowering medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, 82511, Egypt

RECRUITING

MeSH Terms

Conditions

Premature BirthCoronary Artery Disease

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Remon S Adly, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Cardiovascular, Faculty of Medicine, Sohag University, Sohag, Egypt.

Study Record Dates

First Submitted

August 27, 2025

First Posted

September 4, 2025

Study Start

September 4, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

September 5, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations