Ischemic Heart Disease in Male With Prostate Adenocarcinoma

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

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.

Study Overview

• Status: Unknown
• Conditions: Ischemic Heart Disease; Prostate Adenocarcinoma
• Intervention / Treatment: Diagnostic test: ISCHEMIC HEART DISEASE diagnostic

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ukraine
  • Dnipro, Ukraine
    • SE Dnipropetrovsk Medical Academy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ISCHEMIC HEART DISEASE and PROSTATE ADENOCARCINOMA	Diagnostic test: ISCHEMIC HEART DISEASE diagnostic; ISCHEMIC HEART DISEASE diagnostic
No Intervention: ISCHEMIC HEART DISEASE and PROSTATE hyperplasia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiovascular events	cardiovascular events development - myocardial infarction, stroke	1 year

Collaborators and Investigators

• Sponsor: Dnipropetrovsk State Medical Academy

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Anticipated): April 15, 2018
• Study Completion (Anticipated): January 15, 2019

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: March 21, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 23, 2018
• Last Update Submitted That Met QC Criteria: March 21, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: atherosclerosis; angiogenesis; cardiooncology
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Male; Prostatic Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Prostatic Neoplasms; Ischemia; Adenocarcinoma
• Other Study ID Numbers: 832/18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No