Clinical trial NCT02310659: Study to Evaluate the Association of Testosterone Levels With Coronary Artery Calcification
Official title: Study to Evaluate the Association of Testosterone Levels With Coronary Artery in Patients With Stable Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 200
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly male patients (age ≥ 65 years old) with stable angina and proven coronary artery disease

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with severe coronary artery calcification
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 1st Affiliated Hospital, College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Junzhu Chen, MD
role: STUDY_CHAIR
References: