Vascular Calcification, Inflammation and Coronary Flow Velocity in Hemodialysis Patients

NCT00921089 | Completed

• 1 other identifier: 1926
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this cross-sectional study is to determine the correlation of coronary artery calcification as measured by electron-beam computerized tomography and coronary flow reserve measured by trans-thoracic Doppler echocardiography in hemodialysis patients. The investigators also assessed the carotid artery parameters by measuring intima media thickness that can accurately describe the process of arterial wall changes due to atherosclerosis. Possible association of coronary flow reserve with inflammation and arterial calcification in hemodialysis patients was also evaluated.

Conditions

Renal Dialysis; Cardiovascular Diseases; Atherosclerosis; Inflammation

Keywords

Atherosclerosis; Cardiovascular disease; Hemodialysis; Inflammation; Vascular calcification

Outcome Measures

Primary Outcomes (1)

• Comparison of coronary artery calcium scores measured by electron-beam computerized tomography and coronary flow reserve.

  3 months

Secondary Outcomes (1)

• Relationship between coronary artery calcium scores, coronary flow reserve and inflammatory parameters (IL-6,TNF-alpha, hs-CRP).

  3 months

Study Arms (2)

Hemodialysis group

End stage renal disease patients aged lower than 70 years, treated for more than 6 months with hemodialysis

Control group

Normotensive healthy controls

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

End stage renal disease patients and normotensive healthy controls were studied for the assessment of coronary artery calcification score by electron-beam computerized tomography and coronary flow reserve trans-thoracic Doppler harmonic echocardiographyby.

You may qualify if:

• Subject must be 18 years of age or older and able to give informed consent
• End stage renal disease patients treated for more than 6 months with hemodialysis

You may not qualify if:

• Valvular heart disease
• Prior myocardial infarction
• Any prior coronary intervention
• Dilated or hypertrophic cardiomyopathy
• Congestive heart failure
• Cardiac arrhythmia
• Active infection or non-infectious overt inflammation
• Patients whose LAD could not visualized adequately

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

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

Istanbul, 34390, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Atherosclerosis; Inflammation; Vascular Calcification

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alaattin Yildiz, MD

  Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University

  STUDY DIRECTOR

• Yasar Caliskan, MD

  Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 15, 2009
• First Posted: June 16, 2009
• Study Start: April 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 17, 2009

Record last verified: 2009-06

Locations

TU (1)