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

NCT07076771 | Recruiting

• 1 other identifier: Soh-Med-25-5-9PD
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Testosterone; Angiographic Complexity; Coronary Lesion; Premature Ischemia; Males

Outcome Measures

Primary Outcomes (1)

• Serum testosterone level

  Serum testosterone level will be measured.

  Immediately after angiography (Up to 1 hour)

Study Arms (2)

Significant coronary artery disease (CAD) group

Patients with significant coronary artery disease

Other: Coronary Angiography; Other: Syntax Score

Non-significant coronary artery disease (CAD) group

Patients with non-significant coronary artery disease

Other: Coronary Angiography; Other: Syntax Score

Interventions

Coronary Angiography OTHER

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.

Non-significant coronary artery disease (CAD) group; Significant coronary artery disease (CAD) group

Syntax Score OTHER

The angiographic complexity of coronary artery disease (CAD) will be assessed using the SYNTAX score.

Non-significant coronary artery disease (CAD) group; Significant coronary artery disease (CAD) group

Eligibility Criteria

• Age: Up to 45 Years
• Gender Eligibility Details: Male patients diagnosed with premature ischemic heart disease.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, 82511, Egypt

RECRUITING

Central Study Contacts

Remon S Adly, MD

CONTACT

00201221878986; remonsaleh@yahoo.com

Study Design

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

Study Record Dates

• First Submitted: July 12, 2025
• First Posted: July 22, 2025
• Study Start: January 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• 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

EG (1)