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

NCT ID: NCT02310659

Last Updated: 2014-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2015-04-30

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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lower calcificant score group

patients with coronary artery calcificant score \<400

No intervention

Intervention Type OTHER

No intervention

higher calcificant score group

patients with coronary artery calcificant score ≥400

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Jiangtao Lai

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Junzhu Chen, MD

Role: STUDY_CHAIR

Zhejiang University

Locations

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1st Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiangtao Lai, MD

Role: CONTACT

Phone: +8657187236502

Facility Contacts

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Jiangtao Lai, MD

Role: primary

Other Identifiers

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20090206

Identifier Type: -

Identifier Source: org_study_id