Clinical trial NCT03474835: Ischemic Heart Disease in Male With Prostate Adenocarcinoma
Official title: Ischemic Heart Disease in Male With Prostate Adenocarcinoma: Clinical and Pathogenetic Aspects of Diagnostics, Prognosis and Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Heart Disease
Prostate Adenocarcinoma
Keywords: atherosclerosis
angiogenesis
cardiooncology
Lead sponsor: Dnipropetrovsk State Medical Academy
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: Research methods:

1. general-clinical examination
2. 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,
3. Echo-doppler examination of vessels (endothelium-dependent vasodilatation with reactive hyperemia, determination of the thickness of CIM, GPI)
4. Ultrasound examination of the main vessels of the head and neck
5. ECG
6. Daily monitoring of BP
7. CT-angiographic examination of coronary vessels with the definition of the index of calcification
8. Statistical methods

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: cardiovascular events
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dnipro
country: Ukraine
facility: SE Dnipropetrovsk medical academy
Study officials:
References: