NCT01076023

Brief Summary

This study is designed to assess the incidence of cardiovascular events occurred within an 12 month follow up period in type 2 diabetic patients with either high risk of cardiovascular disease (CVD) or history of coronary artery disease (CAD) or stroke.

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
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Typical duration 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, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2010

Enrollment Period

2.7 years

First QC Date

February 24, 2010

Last Update Submit

February 13, 2013

Conditions

Type 2 Diabetes

Keywords

DiabetesCardiovascular diseaseObservational studyChina

Outcome Measures

Primary Outcomes (1)

  • Incidence of cardiovascular events, including fatal and non-fatal acute coronary syndromes (acute myocardial infarction [AMI] or unstable angina), fatal or non-fatal stroke, and other cardiovascular death.

    12 months

Secondary Outcomes (1)

  • Outcomes of current anti-diabetic treatment

    12 months

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Out patients of Tier 3 hospitals

You may qualify if:

  • Patients who are 40 years of age or older
  • Patients with confirmed diagnosis of type II diabetes
  • Patients with 3 or more CVD risk factors or with confirmed/history of CAD or history of ischemic stroke
  • Patients who have lab data within 30 days of baseline visit
  • Patients who are willing to return for all follow up visits

You may not qualify if:

  • Patients who are not willing or not able to return to the same hospital within 12 months after enrollment
  • Patients who have life threatening or terminal disease, or are physically unable to make follow up visits every 6 months after enrollment
  • Patients have severe heart failure (New York Heart Association \[NYHA\] Class 3-4)
  • Patients with severe renal deficiency (creatinine clearance less than 30 ml/min)
  • Patients who are not willing to sign informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weiqing Wang

Shanghai, Shanghai Municipality, 200025, China

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusCardiovascular Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Guang Ning, MD

    Shanghai JiaoTong University RuiJing Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2010

First Posted

February 25, 2010

Study Start

February 1, 2010

Primary Completion

October 1, 2012

Study Completion

March 1, 2013

Last Updated

February 15, 2013

Record last verified: 2010-02

Locations

CN(1)