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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by United States Naval Medical Center, San Diego.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by:
United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier:
NCT00142636
First received: September 1, 2005
Last updated: November 21, 2005
Last verified: August 2005
  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
Official Title: Coronary Artery Calcification in Chronic Kidney Disease Using Multidetector Row Spiral Computed Tomography

Resource links provided by NLM:


Further study details as provided by United States Naval Medical Center, San Diego:

Estimated Enrollment: 200
Study Start Date: February 2004
Estimated Study Completion Date: September 2005
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142636

Locations
United States, California
Naval Medical Center San Diego
San Diego, California, United States, 92134
Sponsors and Collaborators
United States Naval Medical Center, San Diego
Genzyme, a Sanofi Company
Investigators
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:
Renal Insufficiency, Chronic
Kidney Diseases
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on October 19, 2014