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Clinical Trials/NCT02310659
NCT02310659
Unknown
Not Applicable

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

Zhejiang University1 site in 1 country200 target enrollmentMarch 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Zhejiang University
Enrollment
200
Locations
1
Primary Endpoint
Number of participants with severe coronary artery calcification
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
April 2015
Last Updated
11 years ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
Zhejiang University
Responsible Party
Principal Investigator
Principal Investigator

Jiangtao Lai

MD

Zhejiang University

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

Outcomes

Primary Outcomes

Number of participants with severe coronary artery calcification

Time Frame: 10 months

Number of participants with coronary artery calcification score ≥400

Study Sites (1)

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