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Assessment of Compliance With European and French Guidelines for the Management of Dyslipidaemias (OBDYSLIP)

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ClinicalTrials.gov Identifier: NCT03449784
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Tracking Information
First Submitted Date February 22, 2018
First Posted Date February 28, 2018
Last Update Posted Date August 6, 2019
Actual Study Start Date May 1, 2012
Estimated Primary Completion Date November 1, 2040   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 22, 2018)
number with dyslipidemia [ Time Frame: 1 day ]
number of patient with dyslipidemia
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03449784 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 22, 2018)
number of patient not achieving LDL-C target according to cardiovascular risk [ Time Frame: 1 day ]
number of patient not achieving LDL-C target according to cardiovascular risk
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of Compliance With European and French Guidelines for the Management of Dyslipidaemias
Official Title Observatory of Patients With Dyslipidemia Hospitalized in Endocrinology-Diabetology-Nutrition Unit: Observational Study
Brief Summary

Cardiovascular disease (CVD) due to atherosclerosis of the arterial vessel wall and to thrombosis is the foremost cause of premature mortality and of disability-adjusted life years in Europe, and is also increasingly common in developing countries. In the European Union, the economic cost of CVD represents annually €192 billion in direct and indirect healthcare costs. The main clinical entities are coronary artery disease (CAD), ischaemic stroke, and peripheral arterial disease (PAD). The causes of these CVDs are multifactorial. Some of these factors relate to lifestyles, such as tobacco smoking, lack of physical activity, and dietary habits, and are thus modifiable. Other risk factors are also modifiable, such as elevated blood pressure, type 2 diabetes, and dyslipidaemias, or non-modifiable, such as age and male gender. LDL-cholesterol (LDL-C) is one of the major risk factors for CVD, through its role in the development of atherosclerosis. The efficacy of statins has been demonstrated by a considerable amount of literature not only in lowering LDL cholesterol levels but also in reducing cardiovascular events, both in diabetes and non-diabetes patients. Guidelines for the management of dyslipidemia have emerged from different countries. Thereby, in 2016 the French Society of Endocrinology (SFE) and the New French Society of Atherosclerosis (NSFA) published a consensus statement on the management of dyslipidemias integrating features from European recommendations and in 2017 the Haute Autorité de Santé updated the French guidelines. However, LDL-C goal attainment has rarely been assessed specifically in diabetes population, in which CVD is of particular importance. This study aimed to assess the rate of dyslipidaemias in a population of patient hospitalized in Endocrinology-Diabetology-Nutrition unit.

This observational study was carried in the Diabetes-Nutrition unit of the University Hospital of Montpellier - France. All consecutive patients admitted to that unit during the study period were assessed for eligibility. Data on age, sex, tobacco smoking, body mass index, hypertension (treatment of previously diagnosed hypertension or blood values > 140/90 mmHg), presence and type of CVD (coronary artery disease, stroke and transient ischemic attack, peripheral arterial disease), were collected at admission. LDL-C, HDL-C and triglycerides levels calculated with the Friedewald formula, and glomerular filtration rate calculated according to the CKD-EPI formula were obtained from blood samples taken within 24 hours of hospitalization admission. Information on the name and daily dose of lipid lowering drugs (statins, fibrate, ezetimibe …) at admission was documented. Cardiovascular risk level and LDL-C target values were defined according to 2011 and 2016 ESC guidelines and 2017 French guidelines.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Study population was composed of patient hospitalized in Diabetes-Nutrition unit of Montpellier University hospital.
Condition Patient With Dyslipidemia
Intervention Other: Detection of patients with dyslipidemia
Detection of patients with dyslipidemia
Study Groups/Cohorts
  • patients with dyslipidemia non achieving LDL-C target
    patients with dyslipidemia non achieving LDL-C target
    Intervention: Other: Detection of patients with dyslipidemia
  • patients with dyslipidemia achieving LDL-C target
    patients with dyslipidemia achieving LDL-C target
    Intervention: Other: Detection of patients with dyslipidemia
Publications * Breuker C, Clement F, Mura T, Macioce V, Castet-Nicolas A, Audurier Y, Boegner C, Morcrette E, Jalabert A, Villiet M, Avignon A, Sultan A. Non-achievement of LDL-cholesterol targets in patients with diabetes at very-high cardiovascular risk receiving statin treatment: Incidence and risk factors. Int J Cardiol. 2018 Oct 1;268:195-199. doi: 10.1016/j.ijcard.2018.04.068.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 22, 2018)
977
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 1, 2041
Estimated Primary Completion Date November 1, 2040   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria:

- Patients aged above 18 years old, admitted to the department during the study period and hospitalized for at least 24 hours, blood samples taken within 24 hours of hospitalization admission (LDL-C, triglycerides)

Exclusion criteria:

- Patients with elevated triglycerides (>4.5 mmol/L or >400 mg/dL)

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Cyril BREUKER, PharmD,Phd 467337121 ext 33 c-breuker@chu-montpellier.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03449784
Other Study ID Numbers RECHMPL18_0104
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: NC
Responsible Party University Hospital, Montpellier
Study Sponsor University Hospital, Montpellier
Collaborators Not Provided
Investigators
Principal Investigator: Cyril BREUKER University Hospital, Montpellier
PRS Account University Hospital, Montpellier
Verification Date April 2019