Reperfusion InjuryNCT02394405
Myocardial and Renal Dysfunction by Oxidative Stress Caused by Cardiac Surgery
An observational study of Reperfusion Injury, run by Moscow Regional Research and Clinical Institute (MONIKI) at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Reperfusion Injury
- How many people
- 21 participants
- Where
- 1 siteRussia
- Study dates
- Mar 2015to Dec 2018
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- shedduled CABG
Who cannot join
- stroke befor surgery
- miocardial infarction 6 monthes befor surgery
- dementia
- liver cirrhosis
Trial locations and contacts
1 site in 1 country.
Russia1 site
Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
Moscow, 129110
About this study
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.
- Conditions
- Reperfusion Injury
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| valve surgery | valve plasty/replacement surgery | |
| off-pump CABG | off-pump CABG | |
| CPB-CABG | CABG with CardioPulmonal Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assay of mtDNA
Measured: from baseline whithin 72 hours
Secondary outcomes (5)
Assay of nDNA
Measured: from baseline whithin 72 hours
Assay of carbonilated proteins
Measured: from baseline whithin 72 hours
Assay of nitrotyrosine
Measured: from baseline whithin 72 hours
Assay of oxy-LDL
Measured: from baseline whithin 72 hours
Assay of S100b-protein
Measured: from baseline whithin 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reperfusion InjuryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Valery V. Likhvantsev, Professor, Moscow Regional Research and Clinical Institute (MONIKI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394405
- Sponsor's protocol ID
- OD-CABG-2015
- Status last verified
- Aug 2019
- First submitted
- 12 Feb 2015
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial and Renal Dysfunction by Oxidative Stress Caused by Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02394405
- Acronym / sponsor ID
- OD-CABG-2015
- Conditions
- Reperfusion Injury
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)Other government
- Study start
- Mar 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 20 Mar 2015 (estimated)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| valve surgery | – | –valve plasty/replacement surgery |
| off-pump CABG | – | –off-pump CABG |
| CPB-CABG | – | –CABG with CardioPulmonal Bypass |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- shedduled CABG
Key exclusion criteria (4 listed)
- stroke befor surgery
- miocardial infarction 6 monthes befor surgery
- dementia
- liver cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assay of mtDNA
Time frame: from baseline whithin 72 hours
5 secondary outcomes
Assay of nDNA
Time frame: from baseline whithin 72 hours
Assay of carbonilated proteins
Time frame: from baseline whithin 72 hours
Assay of nitrotyrosine
Time frame: from baseline whithin 72 hours
Assay of oxy-LDL
Time frame: from baseline whithin 72 hours
Assay of S100b-protein
Time frame: from baseline whithin 72 hours
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
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The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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Recruiting
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Liver Transplantation (LT), Ischemia-Reperfusion Injury
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?
An observational study of Reperfusion Injury, run by Moscow Regional Research and Clinical Institute (MONIKI) at 1 site in Russia.
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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 15 Aug 2019. 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 Russia. 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?
The study was stopped early. 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?
Assay of mtDNA (time frame: from baseline whithin 72 hours). 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 15 Aug 2019.