Serum Testosterone Level on Angiographic Complexity of Co... | NCT07076771

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

NCT07076771

Sponsor

Sohag University

Status

Recruiting

Last Update Posted

Jul 22, 2025Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Testosterone
Angiographic Complexity
Coronary Lesion
Premature Ischemia
Males

Interventions

Coronary Angiography
Syntax Score

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2025Actual

Primary Completion Date

Aug 1, 2025Estimated

Completion Date

Aug 1, 2025Estimated

First Submitted Date

Jul 12, 2025

First Submission Date that Met QC Criteria

Jul 12, 2025

First Posted Date

Jul 22, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2025

Last Update Posted Date

Jul 22, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Remon Saleh Adly, Lecturer of Cardiovascular, Faculty of Medicine, Sohag University, Sohag, Egypt., Sohag UniversityPrincipal Investigator

Lead Sponsor

Sohag UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Male patients diagnosed with premature ischemic heart disease.

Minimum Age

Not provided

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Remon S Adly, MD	Contact	00201221878986		remonsaleh@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag University	Recruiting	Sohag		82511	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

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.

URL

Not provided