Chronic Kidney DiseaseNCT00142636
CRICKET Study, Coronary Calcium Scores in Patients With Chronic Kidney Disease
An observational study of Chronic Kidney Disease, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Sep 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Ages <18 or >65 years
- Pregnant subjects
- Subjects with history of severe obstructive pulmonary disease, CHF, stroke, arrythmia.
- Dialysis and kidney transplant patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center San Diego
San Diego, California, 92134
About this study
Official title: Coronary Artery Calcification in Chronic Kidney Disease Using Multidetector Row Spiral Computed Tomography
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.
Read the 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.
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kideny Disease, Hypertension
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startFeb 2004
- Study completionSep 2005
Why it stopped: PI/study contacts no longer at Institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Collaborators
- Genzyme, a Sanofi Company
- Investigators
- Dylan E Wessman, M.D., Principal investigator, Naval Medical Center, San Diego, Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142636
- Sponsor's protocol ID
- CIP #S-03-133
- Other IDs
- CRADA CIP # S-03-133
- Status last verified
- Jul 2025
- First submitted
- 1 Sep 2005
- Last updated
- 1 Aug 2025
- Results posted
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Calcification in Chronic Kidney Disease Using Multidetector Row Spiral Computed Tomography
- ClinicalTrials.gov ID
- NCT00142636
- Acronym / sponsor ID
- CIP #S-03-133
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kideny Disease, Hypertension
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI/study contacts no longer at Institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Feb 2004
- Study completion
- Sep 2005
- First posted
- 2 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Ages <18 or >65 years
- Pregnant subjects
- Subjects with history of severe obstructive pulmonary disease, CHF, stroke, arrythmia.
- Dialysis and kidney transplant patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Results publicationDylan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dylan E Wessman, M.D. principal investigator
Naval Medical Center, San Diego, Department of Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by United States Naval Medical Center, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00142636, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.