Clinical Trial: CRICKET Study, Coronary Calcium Scores in Patients with Chronic Kidney Disease
This study is no longer recruiting patients.
| Sponsors and Collaborators: | United States Naval Medical Center, San Diego Genzyme | | Information provided by: | United States Naval Medical Center, San Diego | | ClinicalTrials.gov Identifier: | NCT00142636 | |
Purpose
Patients with
Chronic Kidney Disease (CKD) have been shown to have high coronary
calcium scores (CAC), but the temporal assocition between Glomerulr Filtration Rate, CVD risk factors and CAC has not been described. This is a single-center, longitutidnal, 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.
| Condition |
Chronic Kidney Disease
|
MedlinePlus related topics: Kidney Diseases
Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Prospective Study
Official Title: Coronary Artery Calcification in Chronic Kidney Disease Using Multidetector Row Spiral Computed Tomography
Further Study Details:
Expected Total Enrollment: 200
Study start: February 2004; Study completion: September 2005
Last follow-up: September 2005; Data entry closure: September 2005
Patients with
Chronic Kidney Disease (CKD) have been shown to have high coronary
calcium scores (CAC), but the temporal assocition between Glomerulr Filtration Rate, CVD risk factors and CAC has not been described. This is a single-center, longitutidnal, 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
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
Accepts Healthy Volunteers
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.
Location Information
California Naval Medical Center San Diego, San Diego, California, 92134, United States
Study chairs or principal investigators
Dylan E Wessman, M.D., Principal Investigator, Naval Medical Center, San Diego, Department of Internal Medicine
More Information
Study ID Numbers: CIP #S-03-133; CRADA CIP # S-03-133
Last Updated: September 1, 2005
Record first received: September 1, 2005
ClinicalTrials.gov Identifier: NCT00142636
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13
Source: ClinicalTrials.gov
Cache Date: September 14, 2005