Ischemic Heart Disease in Male With Prostate Adenocarcinoma

NCT ID: NCT03474835

Last Updated: 2018-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-15
• Study Completion Date: 2019-01-15

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

Conditions

Ischemic Heart Disease; Prostate Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

ISCHEMIC HEART DISEASE and PROSTATE ADENOCARCINOMA

Group Type: OTHER

ISCHEMIC HEART DISEASE diagnostic

Intervention Type: DIAGNOSTIC_TEST

ISCHEMIC HEART DISEASE diagnostic

ISCHEMIC HEART DISEASE and PROSTATE hyperplasia

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ISCHEMIC HEART DISEASE diagnostic

ISCHEMIC HEART DISEASE diagnostic

Intervention Type: DIAGNOSTIC_TEST

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.

• Accepts Healthy Volunteers: Yes

Sponsors

Dnipropetrovsk State Medical Academy

OTHER

Sponsor Role: lead

Responsible Party

Oksana Sirenko

professor assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

SE Dnipropetrovsk medical academy

Dnipro, , Ukraine

Countries

Ukraine

Other Identifiers

832/18

Identifier Type: -

Identifier Source: org_study_id