Biological Phosphocalcic Metabolism and Coronary Artery Calcifications

Cardiovascular Disease Clinical Trial

— BIOCAC  

Official title:

Biological Phosphocalcic Metabolism and Coronary Artery Calcifications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02792868
• Other study ID #: 2015.02
• Status: Completed
• Phase: N/A
• First received: May 26, 2016
• Last updated: April 6, 2017
• Start date: April 2016
• Est. completion date: March 2017

Study information

• Verified date: April 2017
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Calcinosis
• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Disease

Intervention

Other:
• 24 h urines analyses
patient collects urines during 24h

Locations

Country	Name	City	State
France	Chu Rangueil	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
French Cardiology Society

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma levels of FGF23 according to the calcium score, determined by an ELISA method		1 day