Coronary Artery DiseaseNCT02765061
Hyponatremia and Hypoalbuminemia is Morbimortality Predictors in Coronary Artery Bypass Graft Surgery
An observational study of Coronary Artery Disease and Hyponatremia, run by Ankara University.
Trial summary
Coronary artery disease is a common medical disease in many populations. The pathogenesis of this disease is very complex. Surgery is one of the treatment choices. Assessing the risk factors will improve the surgical outcome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Hyponatremia, Hypoalbuminemia
- How many people
- 1,157 participants
- Where
- No sites listed yet
- Study dates
- May 2013to May 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary artery disease
Who may be able to join
- Patients who underwent coronary artery bypass graft surgery
- Elective surgery
Who cannot join
- Pediatric patients
- Off-pump surgery
- Emergent surgery
About this study
Official title: Hyponatremia and Hypoalbuminemia is Morbimortality Predictors in Coronary Artery Bypass
Coronary artery disease is a common medical disease in many populations. The pathogenesis of this disease is very complex. Surgery is one of the treatment choices. Assessing the risk factors will improve the surgical outcome. In this study some biochemical parameters were evaluated to find out the relationship between these parameters (electrolytes and albumin vs)
- Conditions
- Coronary Artery Disease, Hyponatremia, Hypoalbuminemia
- Medical subject headings
- Coronary Artery Disease, Hyponatremia, Hypoalbuminemia
What is being measured
The primary outcome is the main question the study is designed to answer.
myocardial infarction
Increase in cardiac enzymes( >0,1 µg/L )
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startMay 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 1,157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CIGDEM YILDIRIM GUCLU, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765061
- Sponsor's protocol ID
- TYİH
- Status last verified
- May 2015
- First submitted
- 5 May 2016
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyponatremia and Hypoalbuminemia is Morbimortality Predictors in Coronary Artery Bypass
- ClinicalTrials.gov ID
- NCT02765061
- Acronym / sponsor ID
- TYİH
- Conditions
- Coronary Artery Disease, Hyponatremia, Hypoalbuminemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,157 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 6 May 2016 (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.
Coronary artery disease is a common medical disease in many populations. The pathogenesis of this disease is very complex. Surgery is one of the treatment choices. Assessing the risk factors will improve the surgical outcome. In this study some biochemical parameters were evaluated to find out the relationship between these parameters (electrolytes and albumin vs)
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease
Key inclusion criteria (2 listed)
- Patients who underwent coronary artery bypass graft surgery
- Elective surgery
Key exclusion criteria (3 listed)
- Pediatric patients
- Off-pump surgery
- Emergent surgery
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
myocardial infarction
Time frame: One month
Increase in cardiac enzymes( >0,1 µg/L )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Hyponatremia, run by Ankara University.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
myocardial infarction (time frame: One month). 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 9 May 2016.