- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02394405
Myocardial and Renal Dysfunction by Oxidative Stress Caused by Cardiac Surgery
August 13, 2019 updated by: Valery V. Likhvantsev, Professor, Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
Assessment of the severity of oxidative stress caused by the on-pump and off-pump cardiac surgery using mtDNA, nDNA, carbonilated proteins, nitrotyrosine, oxy-LDL, S100b-protein.
Study Overview
Status
Terminated
Conditions
Study Type
Observational
Enrollment (Actual)
21
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Moscow, Russian Federation, 129110
- Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
primary care clinic
Description
Inclusion Criteria:
- shedduled CABG
Exclusion Criteria:
- stroke befor surgery
- miocardial infarction 6 monthes befor surgery
- dementia
- liver cirrhosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
---|
valve surgery
valve plasty/replacement surgery
|
off-pump CABG
|
CPB-CABG
CABG with CardioPulmonal Bypass
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assay of mtDNA
Time Frame: from baseline whithin 72 hours
|
from baseline whithin 72 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assay of nDNA
Time Frame: from baseline whithin 72 hours
|
from baseline whithin 72 hours
|
Assay of carbonilated proteins
Time Frame: from baseline whithin 72 hours
|
from baseline whithin 72 hours
|
Assay of nitrotyrosine
Time Frame: from baseline whithin 72 hours
|
from baseline whithin 72 hours
|
Assay of oxy-LDL
Time Frame: from baseline whithin 72 hours
|
from baseline whithin 72 hours
|
Assay of S100b-protein
Time Frame: from baseline whithin 72 hours
|
from baseline whithin 72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
March 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
February 12, 2015
First Submitted That Met QC Criteria
March 16, 2015
First Posted (Estimate)
March 20, 2015
Study Record Updates
Last Update Posted (Actual)
August 15, 2019
Last Update Submitted That Met QC Criteria
August 13, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OD-CABG-2015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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