Myocardial InfarctionNCT02938767
Carotid Intima-media Thickness as Cardiovascular Mortality Predictor in Peritoneal Dialysis Patients
An observational study of Myocardial Infarction, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Cardiovascular (CV) disease is the main cause of death in patients on dialysis. The aim of this study is the long-term prognostic values of carotid intima-media thickness and coronary flow reserve in cardiovascular mortality of peritoneal dialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Myocardial Infarction
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2012to Jan 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients were treated by peritoneal dialysis or followed up as kidney transplant recipient at the Istanbul Medical Faculty from October 1994 to October 2011. Two groups were established for trial as peritoneal dialysis patients and renal transplant recipients. Patients had follow up shorter than six months and missing data not included in the trial
Who may be able to join
- Peritoneal dialysis patients whose followed up at least six months from October 1994 to October 2011 (for study group)
- Kidney transplant recipients whose followed up at least six months from October 1994 to October 2011 (for control group)
Who cannot join
- diabetes mellitus
- valvular heart disease,
- any prior coronary intervention and congestive heart failure
- Patients whose left anterior descending coronary artery (LAD) could not be visualized adequately by Doppler echocardiography were also excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
Istanbul, 34093
About this study
Official title: Carotid Intima-media Thickness and Coronary Flow Reserve as Cardiovascular Event and Mortality Predictors in Peritoneal Dialysis Patients: Results of Seven-year Follow-up From a Single Center
Cardiovascular (CV) disease is the main cause of death in patients on dialysis. The aim of this study is the long-term prognostic values of carotid intima-media thickness and coronary flow reserve in cardiovascular mortality of peritoneal dialysis patients.
Read the detailed description
Endothelial dysfunction (ED) is a precursor and cause of cardiovascular diseases. Defining of endothelial thickness and coronary microvascular function could be useful for detecting ED. Endothelial dysfunction could be assessed by coronary flow reserve (CFR), carotid intima media thickness (IMT). Repeating measurement of IMT and CFR could be predictor of cardiovascular events and mortality in peritoneal dialysis patients.
- Conditions
- Myocardial Infarction
- Keywords
- peritoneal dialysis, carotid intima-media thickness, coronary flow reserve, cardiovascular mortality
- Medical subject headings
- Myocardial Infarction
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 |
|---|---|---|
| peritoneal dialysis patients | 37 peritoneal dialysis patients followed at the Istanbul Medical Faculty from October 1994 to October 2011 | |
| renal transplant recipients | 20 renal transplant recipients followed at the Istanbul Medical Faculty from October 1994 to October 2011 setted as the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diseases morbidity
Measured: 10-15 years
Secondary outcomes (1)
Patient Survival
Measured: 10-15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startJan 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Istanbul 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-control
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasar Caliskan, Istanbul University
- Investigators
- Yasar Caliskan, MD, Principal investigator, Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938767
- Sponsor's protocol ID
- 3221
- Status last verified
- Oct 2016
- First submitted
- 17 Oct 2016
- Last updated
- 20 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Intima-media Thickness and Coronary Flow Reserve as Cardiovascular Event and Mortality Predictors in Peritoneal Dialysis Patients: Results of Seven-year Follow-up From a Single Center
- ClinicalTrials.gov ID
- NCT02938767
- Acronym / sponsor ID
- 3221
- Conditions
- Myocardial Infarction
- Keywords
- peritoneal dialysis, carotid intima-media thickness, coronary flow reserve, cardiovascular mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 19 Oct 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.
Cardiovascular (CV) disease is the main cause of death in patients on dialysis. The aim of this study is the long-term prognostic values of carotid intima-media thickness and coronary flow reserve in cardiovascular mortality of peritoneal dialysis patients.
Detailed description
Endothelial dysfunction (ED) is a precursor and cause of cardiovascular diseases. Defining of endothelial thickness and coronary microvascular function could be useful for detecting ED. Endothelial dysfunction could be assessed by coronary flow reserve (CFR), carotid intima media thickness (IMT). Repeating measurement of IMT and CFR could be predictor of cardiovascular events and mortality in peritoneal dialysis patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| peritoneal dialysis patients | – | –37 peritoneal dialysis patients followed at the Istanbul Medical Faculty from October 1994 to October 2011 |
| renal transplant recipients | – | –20 renal transplant recipients followed at the Istanbul Medical Faculty from October 1994 to October 2011 setted as the control group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients were treated by peritoneal dialysis or followed up as kidney transplant recipient at the Istanbul Medical Faculty from October 1994 to October 2011. Two groups were established for trial as peritoneal dialysis patients and renal transplant recipients. Patients had follow up shorter than six months and missing data not included in the trial
Key inclusion criteria (2 listed)
- Peritoneal dialysis patients whose followed up at least six months from October 1994 to October 2011 (for study group)
- Kidney transplant recipients whose followed up at least six months from October 1994 to October 2011 (for control group)
Key exclusion criteria (4 listed)
- diabetes mellitus
- valvular heart disease,
- any prior coronary intervention and congestive heart failure
- Patients whose left anterior descending coronary artery (LAD) could not be visualized adequately by Doppler echocardiography were also excluded.
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
Diseases morbidity
Time frame: 10-15 years
1 secondary outcome
Patient Survival
Time frame: 10-15 years
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 20 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Yasar Caliskan, MD principal investigator
Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
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 Myocardial Infarction, run by Istanbul University at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 20 Oct 2016. 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 Turkey (Türkiye). 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 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?
Diseases morbidity (time frame: 10-15 years). 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 20 Oct 2016; AzTrials last refreshed its copy on 7 Nov 2026.