Serum Testosterone Level on Angiographic Complexity of Coronary Lesions in Premature Ischemic Egyptian Males

Impact of Serum Testosterone Level on Angiographic Complexity of Coronary Lesions in Premature Ischemic Egyptian Males

This study aims to investigate the association between serum testosterone levels and the angiographic complexity of coronary artery lesions in male patients under 45 years of age presenting with premature ischemic heart disease.

Study Overview

• Status: Recruiting
• Conditions: Males; Testosterone; Angiographic Complexity; Coronary Lesion; Premature Ischemia
• Intervention / Treatment: Other: Coronary Angiography; Other: Syntax Score

Detailed Description

Coronary artery disease (CAD) remains a leading cause of morbidity and mortality worldwide. While traditionally associated with older populations, there is a growing incidence of premature CAD.

Testosterone, the primary male sex hormone, exerts various physiological effects beyond its role in reproductive function. It influences muscle mass, fat distribution, insulin sensitivity, and vascular tone. Low testosterone levels have been associated with adverse metabolic profiles, including increased adiposity, dyslipidemia, and insulin resistance, all of which are established risk factors for atherosclerosis. Furthermore, testosterone deficiency has been linked to endothelial dysfunction, a critical early event in the development of atherosclerotic plaques.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Remon S Adly, MD; Phone Number: 00201221878986; Email: remonsaleh@yahoo.com

Study Locations

• Egypt
  • Sohag, Egypt, 82511
    • Recruiting
    • Sohag University
    • Contact: Remon S Adly, MD; Phone Number: 00201221878986; Email: remonsaleh@yahoo.com
    • Principal Investigator: Sherein F Aziz, MD
    • Principal Investigator: Ahmed I Bedier, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This prospective study will be conducted at Sohag University Hospitals after approval from the institutional ethical committee.

Description

Inclusion Criteria:

• Male patients aged <45 years.
• Diagnosed with premature ischemic heart disease.
• Undergoing elective coronary angiography for suspected coronary artery disease (CAD) .

Exclusion Criteria:

• History of acute coronary syndrome within the preceding 3 months.
• Prior diagnosis of hypogonadism or history of testosterone replacement therapy or anabolic steroid use.
• Active neoplasm or history of chemotherapy.
• Known hepatic cirrhosis, chronic kidney disease, or end-stage renal disease.
• Use of medications known to affect sex hormone levels (e.g., spironolactone, ketoconazole).
• Endocrine disorders such as sickle cell anemia or celiac disease.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Significant coronary artery disease (CAD) group; Patients with significant coronary artery disease	Other: Coronary Angiography; All angiographic procedures will be performed. Coronary artery disease will be defined as >70% stenosis in at least one major epicardial artery or >50% the left main coronary artery.; Other: Syntax Score; The angiographic complexity of coronary artery disease (CAD) will be assessed using the SYNTAX score.
Non-significant coronary artery disease (CAD) group; Patients with non-significant coronary artery disease	Other: Coronary Angiography; All angiographic procedures will be performed. Coronary artery disease will be defined as >70% stenosis in at least one major epicardial artery or >50% the left main coronary artery.; Other: Syntax Score; The angiographic complexity of coronary artery disease (CAD) will be assessed using the SYNTAX score.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum testosterone level	Serum testosterone level will be measured.	Immediately after angiography (Up to 1 hour)

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: July 12, 2025
• First Submitted That Met QC Criteria: July 12, 2025
• First Posted (Actual): July 22, 2025

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 12, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: Soh-Med-25-5-9PD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No