Biological Phosphocalcic Metabolism and Coronary Artery Calcifications

NCT02792868 | Completed

• 1 other identifier: 2015.02
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• plasma levels of FGF23 according to the calcium score, determined by an ELISA method

  1 day

Study Arms (1)

patient

patient with cardiovascular risk (moderate)

Other: 24 h urines analyses

Interventions

24 h urines analyses OTHER

patient collects urines during 24h

patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patient with cardiovascular risk

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• French Cardiology Society: lead

Study Sites (1)

Chu Rangueil

Toulouse, 31000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood 24h urines

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Jean FERRIERES

  CHU RANGUEIL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 8, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 7, 2017

Record last verified: 2017-04

Locations

FR (1)