Ischemic Heart Disease in Male With Prostate Adenocarcinoma
Primary Purpose
Ischemic Heart Disease, Prostate Adenocarcinoma
Status
Unknown status
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
ISCHEMIC HEART DISEASE diagnostic
Sponsored by
About this trial
This is an interventional diagnostic trial for Ischemic Heart Disease focused on measuring atherosclerosis, angiogenesis, cardiooncology
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.
Sites / Locations
- SE Dnipropetrovsk medical academy
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
ISCHEMIC HEART DISEASE and PROSTATE ADENOCARCINOMA
ISCHEMIC HEART DISEASE and PROSTATE hyperplasia
Arm Description
Outcomes
Primary Outcome Measures
cardiovascular events
cardiovascular events development - myocardial infarction, stroke
Secondary Outcome Measures
Full Information
NCT ID
NCT03474835
First Posted
February 28, 2018
Last Updated
March 21, 2018
Sponsor
Dnipropetrovsk State Medical Academy
1. Study Identification
Unique Protocol Identification Number
NCT03474835
Brief Title
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
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
April 15, 2018 (Anticipated)
Study Completion Date
January 15, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dnipropetrovsk State Medical Academy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Prostate Adenocarcinoma
Keywords
atherosclerosis, angiogenesis, cardiooncology
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ISCHEMIC HEART DISEASE and PROSTATE ADENOCARCINOMA
Arm Type
Other
Arm Title
ISCHEMIC HEART DISEASE and PROSTATE hyperplasia
Arm Type
No Intervention
Intervention Type
Diagnostic Test
Intervention Name(s)
ISCHEMIC HEART DISEASE diagnostic
Intervention Description
ISCHEMIC HEART DISEASE diagnostic
Primary Outcome Measure Information:
Title
cardiovascular events
Description
cardiovascular events development - myocardial infarction, stroke
Time Frame
1 year
10. Eligibility
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
SE Dnipropetrovsk medical academy
City
Dnipro
Country
Ukraine
12. IPD Sharing Statement
Learn more about this trial
Ischemic Heart Disease in Male With Prostate Adenocarcinoma
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