Ischemic Heart DiseaseNCT03474835
Ischemic Heart Disease in Male With Prostate Adenocarcinoma
A study testing ISCHEMIC HEART DISEASE diagnostic in people with Ischemic Heart Disease and Prostate Adenocarcinoma, run by Dnipropetrovsk State Medical Academy at 1 site in Ukraine.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ischemic Heart Disease, Prostate Adenocarcinoma
- What is being tested?
- ISCHEMIC HEART DISEASE diagnostic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUkraine
- Study dates
- 15 Jan 2018to 15 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Ischemic Heart Disease, Prostate Adenocarcinoma
- Being tested
- ISCHEMIC HEART DISEASE diagnostic
- Keywords
- atherosclerosis, angiogenesis, cardiooncology
- Medical subject headings
- Myocardial Ischemia, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISCHEMIC HEART DISEASE diagnosticDiagnostic test
ISCHEMIC HEART DISEASE diagnostic
| Study group | Role | What they receive |
|---|---|---|
| ISCHEMIC HEART DISEASE and PROSTATE ADENOCARCINOMA | Other | Not described Receives: Diagnostic Test: ISCHEMIC HEART DISEASE diagnostic |
| ISCHEMIC HEART DISEASE and PROSTATE hyperplasia | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular events
cardiovascular events development - myocardial infarction, stroke
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start15 Jan 2018
- Primary completion15 Apr 2018 (estimated)
- Study completion15 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dnipropetrovsk State Medical Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oksana Sirenko, Dnipropetrovsk State Medical Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474835
- Sponsor's protocol ID
- 832/18
- Status last verified
- Mar 2018
- First submitted
- 28 Feb 2018
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemic Heart Disease in Male With Prostate Adenocarcinoma: Clinical and Pathogenetic Aspects of Diagnostics, Prognosis and Treatment
- ClinicalTrials.gov ID
- NCT03474835
- Acronym / sponsor ID
- 832/18
- Conditions
- Ischemic Heart Disease, Prostate Adenocarcinoma
- Keywords
- atherosclerosis, angiogenesis, cardiooncology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dnipropetrovsk State Medical AcademyUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 15 Apr 2018 (estimated)
- Study completion
- 15 Jan 2019 (estimated)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ISCHEMIC HEART DISEASE and PROSTATE ADENOCARCINOMA | Other | Diagnostic Test: ISCHEMIC HEART DISEASE diagnostic |
| ISCHEMIC HEART DISEASE and PROSTATE hyperplasia | No intervention | – |
Who may qualify
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISCHEMIC HEART DISEASE diagnosticISCHEMIC HEART DISEASE diagnostic | Diagnostic test | ISCHEMIC HEART DISEASE and PROSTATE ADENOCARCINOMA |
Primary outcome
cardiovascular events
Time frame: 1 year
cardiovascular events development - myocardial infarction, stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ISCHEMIC HEART DISEASE diagnostic in people with Ischemic Heart Disease and Prostate Adenocarcinoma, run by Dnipropetrovsk State Medical Academy at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018.