NCT02938767

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
Last Updated

October 20, 2016

Status Verified

October 1, 2016

Enrollment Period

3 years

First QC Date

October 17, 2016

Last Update Submit

October 19, 2016

Conditions

Keywords

peritoneal dialysiscarotid intima-media thicknesscoronary flow reservecardiovascular mortality

Outcome Measures

Primary Outcomes (1)

  • Diseases morbidity

    10-15 years

Secondary Outcomes (1)

  • Patient Survival

    10-15 years

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine

Istanbul, 34093, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

hemogram, serum creatinine, uric asid, calcium, phosphorus and albumin

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Yasar Caliskan, MD

    Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 19, 2016

Study Start

January 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

October 20, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations