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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02938767
Other study ID # 3221
Secondary ID
Status Completed
Phase N/A
First received October 17, 2016
Last updated October 19, 2016
Start date January 2012
Est. completion date January 2015

Study information

Verified date October 2016
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diseases morbidity 10-15 years Yes
Secondary Patient Survival 10-15 years Yes
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