NCT01732952

Brief Summary

This cross-sectional, non-interventional, and observational study will assess the lipid profile of patients who have been taking lipid-modifying drugs (i.e., proportion of patients achieving treatment to goal according to national and international lipid management guidelines) during a single visit to their physicians on an outpatient basis in 6 representative geo-economic regions in China: Northeast, North, East, South, Southwest, and Northwest; and within each region, in three tiers of hospitals: tier 3 (primary or teaching hospitals), tier 2 (secondary or city level hospitals), and tier 1 (community hospitals/health centers). The investigators will primarily be cardiologists, endocrinologists, neurologists, gerontologists, internists, or other physicians who are representative of the general population of physicians managing patients with dyslipidemia and/or at high risk for cardiovascular events likely to be treated with lipid-modifying drugs. Demographic data, cardiovascular risk factors, a history of cardiovascular disease and cardiovascular treatments will be documented in a single visit through patient clinical examination and chart review. DYSIS-China is part of a string of epidemiological studies that share the same master protocol, which has been conducted in different countries mainly in Europe and Canada. The analysis of the pooled studies including overall data and cross-country comparisons is the subject of a distinct protocol.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2012

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 26, 2012

Status Verified

November 1, 2012

Enrollment Period

2 months

First QC Date

November 20, 2012

Last Update Submit

November 23, 2012

Conditions

Keywords

the prevalence,lipid abnormalities,CV risks

Outcome Measures

Primary Outcomes (1)

  • the prevalence and types of persistent lipid abnormalities in patients aged > 45 years treated with a lipid-modifying drug

    6 months

Secondary Outcomes (1)

  • assess patient characteristics, including CV risk levels, in the subsets of patients with persistent lipid abnormalities

    6months

Other Outcomes (1)

  • explore a potential relationship between the persistence of lipid abnormalities and the local known (historical) prevalence of CV morbidity/mortality

    6months

Study Arms (1)

regions,hospitals,age, gender, risk levels, comorbidity,

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

1. Patient is an outpatient \> 45 years of age 2. Patient is currently\* treated with a statin 3. Patient has a documented fasting lipid profile (\> 1 lipid parameter within the last 12 months) performed while on lipid-modifying therapy for at least 3 months 4. Patient agrees to participate in the study by giving informed consent. * Patient is already being treated with a lipid-modifying drug just before the visit. Patient for whom a lipid-modifying therapy is initiated at the time of the visit must not be included.

You may qualify if:

  • Patient is an outpatient \> 45 years of age
  • Patient is currently\* treated with a statin
  • Patient has a documented fasting lipid profile (\> 1 lipid parameter within the last 12 months) performed while on lipid-modifying therapy for at least 3 months
  • Patient agrees to participate in the study by giving informed consent.
  • Patient is already being treated with a lipid-modifying drug just before the visit. Patient for whom a lipid-modifying therapy is initiated at the time of the visit must not be included.

You may not qualify if:

  • \. Patient is currently participating in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peiking University People' Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (2)

  • Chen Y, Yin C, Li Q, Yu L, Zhu L, Hu D, Sun Y. Misuse of Aspirin and Associated Factors for the Primary Prevention of Cardiovascular Disease. Front Cardiovasc Med. 2021 Sep 3;8:720113. doi: 10.3389/fcvm.2021.720113. eCollection 2021.

  • Yan X, Li Y, Dong Y, Wu Y, Li J, Bian R, Hu D. Blood pressure and low-density lipoprotein cholesterol control status in Chinese hypertensive dyslipidemia patients during lipid-lowering therapy. Lipids Health Dis. 2019 Jan 29;18(1):32. doi: 10.1186/s12944-019-0974-y.

Study Officials

  • Hu da yi, Dr.

    Chinese Society of Cardiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chinese Society of Cardiology

Study Record Dates

First Submitted

November 20, 2012

First Posted

November 26, 2012

Study Start

February 1, 2012

Primary Completion

April 1, 2012

Study Completion

December 1, 2012

Last Updated

November 26, 2012

Record last verified: 2012-11

Locations