An EpiDemiological Study Evaluating AbdoMinal AOrta CalcificatioN ScoreS in End STage Renal Disease IndiAn PatienTs New to HEmodialysis (DEMONSTRATE)

Not Applicable

Registration Number: CTRI/2010/091/006131

Lead Sponsor: Dr. Georgi AbrahamMadras Medical Mission4-A, Dr. J. Jayalalitha Nagar,Mogappair, Chennai - 600 037Telephone: +91-44- 26561801 ext: 2800

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 1500

Inclusion Criteria

1. Male and female patient aged > 18 years.
2. Diagnosed with ESRD and on hemodialysis for at least 4 weeks and maximum of 3 months prior to the signing of the informed consent.
3. The patient must be willing and able to provide written informed consent.
4. If female of child-bearing potential, must have a negative urine/serum pregnancy test. Otherwise, females must have been surgically sterile, or postmenopausal (as documented in medical history) for at least 1 year

Exclusion Criteria

1. Pregnant or breast feeding women.
2. Stage I-IV CKD patients.
3. ESRD patients not on hemodialysis
4. Patients on peritoneal dialysis
5. Unable to comply with study requirements.
6. The patient has any clinically significant disease, other than ESRD or other medical conditions, or serious intercurrent illnesses that, in the opinion of the Investigator, may preclude participation in the study.
7. Any other medical/surgical condition, which in the opinion of the investigator and/or radiologist could interfere with conduct of the lateral lumbar X-ray.
8. Patient has previously undergone kidney transplant.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess abdominal aorta calcification (AAC) in End Stage Renal Disease (ESRD) patients new to hemodialysis through Abdominal Aorta Calcification Score (AACS) using lateral abdominal X-RayTimepoint: A period of approximately 12 months is anticipated from the time the first patient is enrolled in the study to the completion of the study (last patient out).<br><br>Each patient?s duration of participation in this epidemiological study is for a maximum of 7 days from the time informed consent is provided by the patient (or discontinuation / withdrawal).<br>

Secondary Outcome Measures