- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02310659
Study to Evaluate the Association of Testosterone Levels With Coronary Artery Calcification
Study to Evaluate the Association of Testosterone Levels With Coronary Artery in Patients With Stable Coronary Artery Disease
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Zhejiang
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Hangzhou, Zhejiang, 중국, 310003
- 모병
- 1st Affiliated Hospital, College of Medicine, Zhejiang University
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연락하다:
- Jiangtao Lai, MD
- 전화번호: +8657187236500
- 이메일: ericlaijt1@163.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
lower calcificant score group
patients with coronary artery calcificant score <400
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개입 없음
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higher calcificant score group
patients with coronary artery calcificant score ≥400
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개입 없음
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of participants with severe coronary artery calcification
기간: 10 months
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Number of participants with coronary artery calcification score ≥400
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10 months
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공동 작업자 및 조사자
수사관
- 연구 의자: Junzhu Chen, MD, Zhejiang University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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