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Carotid Intima-media Thickness as Cardiovascular Mortality Predictor in Peritoneal Dialysis Patients

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ClinicalTrials.gov Identifier: NCT02938767
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : October 20, 2016
Sponsor:
Information provided by (Responsible Party):
Yasar Caliskan, Istanbul University

Brief 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.

Condition or disease
Myocardial Infarction

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.

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Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Case Control
Time Perspective: Prospective
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
Study Start Date : January 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Group/Cohort
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



Primary Outcome Measures :
  1. Diseases morbidity [ Time Frame: 10-15 years ]

Secondary Outcome Measures :
  1. Patient Survival [ Time Frame: 10-15 years ]

Biospecimen Retention:   Samples Without DNA
hemogram, serum creatinine, uric asid, calcium, phosphorus and albumin


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938767


Locations
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Turkey
Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
Istanbul, Turkey, 34093
Sponsors and Collaborators
Istanbul University
Investigators
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Principal Investigator: Yasar Caliskan, MD Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine

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Responsible Party: Yasar Caliskan, MD Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University
ClinicalTrials.gov Identifier: NCT02938767     History of Changes
Other Study ID Numbers: 3221
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: October 20, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Yasar Caliskan, Istanbul University:
peritoneal dialysis
carotid intima-media thickness
coronary flow reserve
cardiovascular mortality

Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases