Ischemic Heart Disease in Male With Prostate Adenocarcinoma

Ischemic Heart Disease Clinical Trial

Official title:

Ischemic Heart Disease in Male With Prostate Adenocarcinoma: Clinical and Pathogenetic Aspects of Diagnostics, Prognosis and Treatment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03474835
• Other study ID #: 832/18
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 28, 2018
• Last updated: March 21, 2018
• Start date: January 15, 2018
• Est. completion date: January 15, 2019

Study information

• Verified date: March 2018
• Source: Dnipropetrovsk State Medical Academy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: January 15, 2019
• Est. primary completion date: April 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia
• Prostate Adenocarcinoma
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• ISCHEMIC HEART DISEASE diagnostic
ISCHEMIC HEART DISEASE diagnostic

Locations

Country	Name	City	State
Ukraine	SE Dnipropetrovsk medical academy	Dnipro

Sponsors (1)

Lead Sponsor	Collaborator
Dnipropetrovsk State Medical Academy

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiovascular events	cardiovascular events development - myocardial infarction, stroke	1 year