Ischemic Heart Disease in Male With Prostate Adenocarcinoma
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2018
CompletedFirst Submitted
Initial submission to the registry
February 28, 2018
CompletedFirst Posted
Study publicly available on registry
March 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2019
CompletedMarch 23, 2018
March 1, 2018
3 months
February 28, 2018
March 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cardiovascular events
cardiovascular events development - myocardial infarction, stroke
1 year
Study Arms (2)
ISCHEMIC HEART DISEASE and PROSTATE ADENOCARCINOMA
OTHERISCHEMIC HEART DISEASE and PROSTATE hyperplasia
NO INTERVENTIONInterventions
ISCHEMIC HEART DISEASE diagnostic
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SE Dnipropetrovsk medical academy
Dnipro, Ukraine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor assistant
Study Record Dates
First Submitted
February 28, 2018
First Posted
March 23, 2018
Study Start
January 15, 2018
Primary Completion
April 15, 2018
Study Completion
January 15, 2019
Last Updated
March 23, 2018
Record last verified: 2018-03