NCT03474835Unknown不适用
Ischemic Heart Disease in Male With Prostate Adenocarcinoma: Clinical and Pathogenetic Aspects of Diagnostics, Prognosis and Treatment
Dnipropetrovsk State Medical Academy1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年1月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- cardiovascular events
研究概览
简要总结
The purpose of the study: to increase the efficiency of diagnosis, treatment and prediction of the course of coronary heart disease in patients with adenocarcinoma of the prostate gland, depending on the hormonal status by determining the cardiovascular risk factors, factors of angiogenesis, structural and functional state of the heart, coronary vessels, kidney damage and their pharmacological correction.
详细描述
Research methods:
- general-clinical examination
- Laboratory methods:
- estimation of the generally accepted laboratory parameters
- determination of blood lipid profile
- Determination of the level of highly sensitive CRP by the method of immuno-enzyme analysis,
- determination of the level of proteinuria, creatinine by the method of immuno-enzyme analysis with the subsequent calculation of GFR
- determination of the level of insulin by the method of immuno-enzyme analysis with the subsequent calculation of indices of insulin resistance,
- determination of the level of blood testosterone by the method of immuno-enzyme analysis,
- determination of the levels of vascular-endothelial growth factor, angiosetamine by the immuno-enzyme assay,
- Echo-doppler examination of vessels (endothelium-dependent vasodilatation with reactive hyperemia, determination of the thickness of CIM, GPI)
- Ultrasound examination of the main vessels of the head and neck
- ECG
- Daily monitoring of BP
- CT-angiographic examination of coronary vessels with the definition of the index of calcification
- Statistical methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 接受健康志愿者
- 是
入选标准
- •men aged 45-75 years
- •presence of verified diagnosis of adenocarcinoma of the prostate gland,
- •stable antitumor therapy for 6 months, verified diagnosis of CAD,
- •stable cardiological therapy for the past 3 months,
- •voluntary informed consent to participate in the study.
排除标准
- •age older than 75 years,
- •female sex,
- •metastatic lesion,
- •chronic heart failure of the III-IV functional class (FC),
- •arrhythmias that cause hemodynamic impairment and require antiarrhythmic correction (including ventricular arrhythmias of high gradation, atrial flutter , paroxysmal tachycardia, sinus node weakness syndrome, 2-3-degree AV block),
- •AMI, acute cerebrovascular accident,
- •diabetes mellitus (insulin-dependent diabetes mellitus) with a level of NvA1s> 7%, hyperthyroidism and hypothyroidism level of TSH> 10 mD / L, chronic renal failure (GFR <30 ml / min / 1.73 m2),
- •acute cardiac and renal insufficiency,
- •obesity 4 degrees,
- •cachexia.
研究组 & 干预措施
ISCHEMIC HEART DISEASE and PROSTATE ADENOCARCINOMA
Other
干预措施: ISCHEMIC HEART DISEASE diagnostic (Diagnostic Test)
ISCHEMIC HEART DISEASE and PROSTATE hyperplasia
No Intervention
结局指标
主要结局
cardiovascular events
时间窗: 1 year
cardiovascular events development - myocardial infarction, stroke
次要结局
未报告次要终点
研究者
Oksana Sirenko
professor assistant
Dnipropetrovsk State Medical Academy
研究点 (1)
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