Clinical trial NCT00142636: CRICKET Study, Coronary Calcium Scores in Patients With Chronic Kidney Disease
Official title: Coronary Artery Calcification in Chronic Kidney Disease Using Multidetector Row Spiral Computed Tomography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Disease
Keywords: Chronic Kideny Disease
Hypertension
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2005-09-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
Study officials:
affiliation: Naval Medical Center, San Diego, Department of Internal Medicine
name: Dylan E Wessman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.