CRICKET Study, Coronary Calcium Scores in Patients With Chronic Kidney Disease

• Conditions: Chronic Kidney Disease

• Registration Number: NCT00142636
• Lead Sponsor: United States Naval Medical Center, San Diego

Brief Summary

Patients with Chronic Kidney Disease (CKD) have been shown to have high coronary calcium scores (CAC), but the temporal association between Glomerular Filtration Rate, CVD risk factors and CAC has not been described. This is a single-center, longitudinal, observational study. Subjects included adults aged 18 years to 65 years old without preexisting coronary artery disease (CAD). The CKD subjects (GFR \< 60 ml/min) and the control subjects (GFR \>/=60ml/min) were recruited. Laboratory measurements and MDCT scan were performed at baseline and after 12 months. Baseline CAC and average intact parathyroid hormone (iPTH) level were significantly greater in the CKD group. Baseline CAC scores of the CKD group were twice the value of the control group; however, CAC scores over one year were unchanged from baseline.

Detailed Description

Patients with Chronic Kidney Disease (CKD) have been shown to have high coronary calcium scores (CAC), but the temporal association between Glomerular Filtration Rate, CVD risk factors and CAC has not been described. This is a single-center, longitudinal, observational study. Subjects included adults aged 18 years to 65 years old without preexisting coronary artery disease (CAD). The CKD subjects (GFR \< 60 ml/min) were recruited from the Nephrology Clinic, and the control subjects (GFR \>/=60ml/min) were recruited from the Internal Medicine Clinic. Laboratory measurements and MDCT scan were performed at baseline and after 12 months. Baseline CAC and average intact parathyroid hormone (iPTH) level were significantly greater in the CKD group. Baseline CAC scores of the CKD group were twice the value of the control group; however, CAC scores over one year were unchanged from baseline. These observations suggest that CAC begins in earlier stages of CKD. Moreover, novel CVD risk factors including iPTH may accelerate CAD progression in CKD.

Study Timeline

• Study Start: 2004-02
• Status Verified: 2005-08
• Study Completion: 2005-09
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-02
• Last Update Submitted: 2005-11-21
• Last Update Posted: 2005-11-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Male and Female ages 18 to 65 years
• Chronic Kidney disease patients, GFR <60mL/min as defined by MDRD (Levey) formula.
• Healthy volunteer controls, GFR >/= 60 mL/min
• Signed, written informed consent

Exclusion Criteria

• Ages <18 or >65 years
• Pregnant subjects
• Subjects with history of severe obstructive pulmonary disease, CHF, stroke, arrythmia.
• Dialysis and kidney transplant patients.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Naval Medical Center San Diego; 🇺🇸 San Diego, California, United States