Clinical trial NCT01031277: Centralized Pan-Middle East Survey on the Under-treatment of Hypercholesterolemia, Sub-study for the Gulf States
Official title: Centralized Gulf States Survey on the Undertreatment of Hypercholesterolemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Keywords: Hypercholesterolemia
Update NCEP ATP111
Survey
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Clinart International
First posted: 2009-12-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inhabitants of Gulf States visiting their cardiologist for regular follow-up of their hypercholesterolaemia treatment

Brief summary: The purpose of the study is to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the NCEP ATP III/updated 2004 NCEP ATP III guidelines, overall and by country, to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the NCEP ATP III/updated 2004 NCEP ATP III in the following sub-populations:

* Primary/secondary prevention patients.
* Patients with metabolic syndrome (according to NCEP III definition). And to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Third Joint European Task Force guidelines/national guidelines, in the survey population and in the following sub-populations:

  * Primary/secondary prevention patients.
  * Patients with metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* Race
* On lipid-lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks.
* Subject must sign informed consent

Exclusion Criteria:

* Subjects who are unwilling or unable to provide informed consent.

Primary outcomes:
measure: To establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the NCEP ATP III/updated 2004 NCEP ATP III guidelines, overall and by country.
timeFrame: 6 months- One visit only, no follow up visits.
Secondary outcomes:
measure: Proportion patients on lipid-lowering drugs (LLD) reaching the LDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III in subgroups: Primary/secondary prevention patients; Patients with metabolic syndrome ( NCEP III).
timeFrame: 6 months- One visit only, no follow up visits.
measure: Proportion patients on LLD reaching the LDL-C goals according to the Third Joint European Task Force guidelines/national guidelines, in the survey population and in sub-populations: Primary/secondary prevention patients; Patients with metabolic syndrome.
timeFrame: 6 months- One visit only, no follow up visits.
measure: To identify determinants (e.g. patient and physician characteristics, country-specific guidelines or recommendations) for undertreatment of hypercholesterolemia.
timeFrame: 6 months- One visit only, no follow up visits.
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Research Site
Study officials:
affiliation: Shaikh Khalifa Medical City
name: Prof. Wael Al Mahmeed
role: STUDY_CHAIR
References:
citation: Shehab A, Al-Rasadi K, Arafah M, Al-Hinai AT, Al Mahmeed W, Bhagavathula AS, Al Tamimi O, Al Herz S, Al Anazi F, Al Nemer K, Metwally O, Alkhadra A, Fakhry M, Elghetany H, Medani AR, Yusufali AH, Al Jassim O, Al Hallaq O, Baslaib FOAS, Alawadhi M, Amin H, Al-Hashmi K, Oulhaj A. The Management of Dyslipidaemia in Patients with Type 2 Diabetes Mellitus Receiving Lipid-Lowering Drugs: A Sub-Analysis of the CEPHEUS Findings. Curr Vasc Pharmacol. 2018;16(4):368-375. doi: 10.2174/1570161115666170705153815.