CRICKET Study, Coronary Calcium Scores in Patients With Chronic Kidney Disease
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition |
|---|
|
Chronic Kidney Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Defined Population Primary Purpose: Screening Time Perspective: Longitudinal Time Perspective: Prospective |
| Official Title: | Coronary Artery Calcification in Chronic Kidney Disease Using Multidetector Row Spiral Computed Tomography |
| Estimated Enrollment: | 200 |
| Study Start Date: | February 2004 |
| Estimated Study Completion Date: | September 2005 |
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| United States, California | |
| Naval Medical Center San Diego | |
| San Diego, California, United States, 92134 | |
| Principal Investigator: | Dylan E Wessman, M.D. | Naval Medical Center, San Diego, Department of Internal Medicine |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00142636 History of Changes |
| Other Study ID Numbers: | CIP #S-03-133, CRADA CIP # S-03-133 |
| Study First Received: | September 1, 2005 |
| Last Updated: | November 21, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by United States Naval Medical Center, San Diego:
|
Chronic Kideny Disease Hypertension |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on May 19, 2013