- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina, 310003
- Rekrytering
- 1st Affiliated Hospital, College of Medicine, Zhejiang University
-
Kontakt:
- Jiangtao Lai, MD
- Telefonnummer: +8657187236500
- E-post: ericlaijt1@163.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
lower calcificant score group
patients with coronary artery calcificant score <400
|
Inget ingripande
|
higher calcificant score group
patients with coronary artery calcificant score ≥400
|
Inget ingripande
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of participants with severe coronary artery calcification
Tidsram: 10 months
|
Number of participants with coronary artery calcification score ≥400
|
10 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Junzhu Chen, MD, Zhejiang University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20090206 (The Danish National Committee on Biomedical Research Ethics)
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