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

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