Study to Evaluate the Association of Testosterone Levels With Coronary Artery Calcification

Coronary Artery Disease Clinical Trial

Official title:

Study to Evaluate the Association of Testosterone Levels With Coronary Artery in Patients With Stable Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02310659
• Other study ID #: 20090206
• Status: Recruiting
• Phase: N/A
• First received: December 1, 2014
• Last updated: December 3, 2014
• Start date: March 2009
• Est. completion date: April 2015

Study information

• Verified date: December 2014
• Source: Zhejiang University
• Contact: Jiangtao Lai, MD
• Phone: +8657187236502
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Coronary artery calcification (CAC) is a pandemic condition in elderly patients with coronary artery disease (CAD) and associated with worse prognosis. Although available data shows association between testosterone levels in men and CAD, the association between testosterone and CAC in old-aged male patients with CAD remains unknown. In this study, the relationship of serum testosterone levels with CAC score in elderly male patients with CAD was evaluated.

Description:

Coronary artery calcification (CAC) is associated with worse outcomes in patients with coronary artery disease (CAD), especially in old-aged population. Extensive CAC also increases the risk of procedure associated complications, such as stent migration, coronary artery perforation, dissection and thrombosis. The pathogenesis of CAC has not been fully explained. Recent evidence suggests that CAC share common pathways with bone formation. So, it can be presumed that risk factors contributing to bone formation and resorption activity also affect the development of CAC. Sex hormones is known to play an important role in bone development and in bone quality maintenance. Available data shows that androgens may affect differentiation, proliferation, and apoptosis of osteocytes, osteoclasts, and osteoblasts. Androgen receptor expression has been detected on different types of cells which contributing to the bone formation, such as osteoblastes, osteocytes and condrocytes, and androgen deprivation therapy results negative effects on bone mineral density in patients with metastatic prostate cancer. Osteoporosis, a systemic disease characterized by bone tissue loss, is more prevalent in oler men with low testosterone levels. In CAC, pathophysiological researches show that several vascular cell types, such as vascular smooth muscle cells, adventitial myofibroblasts and microvascular pericytes, have the potential to produce mineralized matrix and differentiate into osteoblasts. So, it can be postulated that androgens may play a similar role in the development of CAC.

Up to date, only limited data is available about the association between testosterone and CAC. A single-center study with relatively small sample revealed an inverse association between testosterone and CAC in non-obese men. The aim of this study was to investigate the association between testosterone and CAC measured as CAC score in old-aged male patients with CAD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Elderly male patients (age = 65 years old) with stable angina and proven coronary artery disease

Exclusion Criteria:

• Less than 65 years old

• Acute coronary syndrome

• History of PCI or coronary artery bypass grafting

• History of myocardial infarction

• Renal dysfunction defined by glomerular filtration rate < 30 mL/min

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	1st Affiliated Hospital, College of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with severe coronary artery calcification	Number of participants with coronary artery calcification score =400	10 months	No