TestosteroneNCT07076771
Serum Testosterone Level on Angiographic Complexity of Coronary Lesions in Premature Ischemic Egyptian Males
An observational study of Testosterone and Angiographic Complexity, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 45 years, men only
- Conditions the study is for
- Testosterone, Angiographic Complexity, Coronary Lesion
- What is being tested?
- Coronary Angiography and Syntax Score
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 45 years
- Men only
- No healthy volunteers
- Child, Adult
Study population: This prospective study will be conducted at Sohag University Hospitals after approval from the institutional ethical committee.
Who may be able to join
- Male patients aged <45 years.
- Diagnosed with premature ischemic heart disease.
- Undergoing elective coronary angiography for suspected coronary artery disease (CAD) .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag, 82511
Remon S Adly, MD, 00201221878986, remonsaleh@yahoo.com
Sherein F Aziz, MD
About this study
Official title: 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.
Read the 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.
- Being tested
- Coronary Angiography, Syntax Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary AngiographyOther
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.
Syntax ScoreOther
The angiographic complexity of coronary artery disease (CAD) will be assessed using the SYNTAX score.
| Study group | Role | What they receive |
|---|---|---|
| Significant coronary artery disease (CAD) group | Patients with significant coronary artery disease Receives: Other: Coronary Angiography; Other: Syntax Score | |
| Non-significant coronary artery disease (CAD) group | Patients with non-significant coronary artery disease Receives: Other: Coronary Angiography; Other: Syntax Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum testosterone level
Serum testosterone level will be measured.
Measured: Immediately after angiography (Up to 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Jan 2025
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TestosteroneStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Remon Saleh Adly, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076771
- Sponsor's protocol ID
- Soh-Med-25-5-9PD
- Status last verified
- Jul 2025
- First submitted
- 12 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Serum Testosterone Level on Angiographic Complexity of Coronary Lesions in Premature Ischemic Egyptian Males
- ClinicalTrials.gov ID
- NCT07076771
- Acronym / sponsor ID
- Soh-Med-25-5-9PD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Significant coronary artery disease (CAD) group | – | Other: Coronary Angiography, Other: Syntax ScorePatients with significant coronary artery disease |
| Non-significant coronary artery disease (CAD) group | – | Other: Coronary Angiography, Other: Syntax ScorePatients with non-significant coronary artery disease |
Who may qualify
- Ages
- Up to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This prospective study will be conducted at Sohag University Hospitals after approval from the institutional ethical committee.
Key inclusion criteria (3 listed)
- Male patients aged <45 years.
- Diagnosed with premature ischemic heart disease.
- Undergoing elective coronary angiography for suspected coronary artery disease (CAD) .
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary AngiographyAll 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 | Non-significant coronary artery disease (CAD) group, Significant coronary artery disease (CAD) group |
| Syntax ScoreThe angiographic complexity of coronary artery disease (CAD) will be assessed using the SYNTAX score. | Other | Non-significant coronary artery disease (CAD) group, Significant coronary artery disease (CAD) group |
Primary outcome
Serum testosterone level
Time frame: Immediately after angiography (Up to 1 hour)
Serum testosterone level will be measured.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Testosterone and Angiographic Complexity, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Remon S Adly, MD (00201221878986, remonsaleh@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum testosterone level (time frame: Immediately after angiography (Up to 1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.