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

Chronic Kidney Disease Clinical Trial

Official title:

Coronary Artery Calcification in Chronic Kidney Disease Using Multidetector Row Spiral Computed Tomography

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00142636
• Other study ID #: CIP #S-03-133
• Secondary ID: CRADA CIP # S-03
• Status: Active, not recruiting
• Phase: N/A
• First received: September 1, 2005
• Last updated: November 21, 2005
• Start date: February 2004
• Est. completion date: September 2005

Study information

• Verified date: August 2005
• Source: United States Naval Medical Center, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
United States	Naval Medical Center San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego	Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dylan Wessman, M.D., Sandra Gilbert, Frank Mullens, M.D., Robin Parker, M.D., John Hammes, M.D., Lou Brenner, M.D. and Amit Sharma, M.D.