- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02792868
Biological Phosphocalcic Metabolism and Coronary Artery Calcifications (BIOCAC)
April 6, 2017 updated by: French Cardiology Society
Study a sample of patients in primary prevention, moderate cardiovascular risk (n = 83 patients), with normal, non-diabetic renal function.
The investigators quantify the phophocalcic intake and excretion, realizing a food examination and a urine collection of 24 particular.
The investigators will measure plasma levels of FGF23 serum calcium, phosphatemia, the investigators will calculate the tubular reabsorption of phosphate.
The investigators will conduct a quantitative assessment of coronary calcification by a non-injected CT scan, measuring semi automated way Agatston calcium score.
There will be an analysis of collinearity.
An adjustment will be made for confounding variables in a generalized linear regression model.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
83
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Toulouse, France, 31000
- CHU Rangueil
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patient with cardiovascular risk
Description
Inclusion Criteria:
- Hospitalization for a cardiovascular check in the Detection Centre and the Atherosclerosis Prevention (CHU Rangueil Toulouse)
- In primary prevention of coronary heart disease
- Introducing an intermediate cardiovascular risk according to the European SCORE equation, that is to say, a risk of cardiovascular death at 10 years greater than or equal to 1% and less than 5%
- signed the informed consent,
Exclusion Criteria:
- Chronic renal failure patients with an estimated GFR less than 60 mL / min / 1.73m2, due to alterations in phosphate metabolism,
- Patients receiving glucose-lowering therapy,
- Patients with a fasting blood glucose greater capillary or equal to 1.10 g / l, confirmed by a plasma glucose greater than or equal to 1.10g / l.
- The diuretic therapy patients (due to a change in urinary electrolytes)
- HIV-positive patients for HIV, antiretroviral (due to a change in urinary electrolytes)
- Pregnant women,
- Patients under judicial protection, guardianship or trusteeship.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patient
patient with cardiovascular risk (moderate)
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patient collects urines during 24h
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
plasma levels of FGF23 according to the calcium score, determined by an ELISA method
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jean FERRIERES, CHU Rangueil
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
May 26, 2016
First Submitted That Met QC Criteria
June 2, 2016
First Posted (Estimate)
June 8, 2016
Study Record Updates
Last Update Posted (Actual)
April 7, 2017
Last Update Submitted That Met QC Criteria
April 6, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015.02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.