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A Comprehensive Longitudinal Cohort Study in Type 2 Diabetes With High Risk of Cardiovascular Diseases in China (CCMR-3B Ext)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
VitalStrategic Research Institute
Gerontological Society of China
Chinese Medical Doctor Association
Information provided by (Responsible Party):
China Cardiometabolic Registries
ClinicalTrials.gov Identifier:
NCT01307410
First received: March 1, 2011
Last updated: February 13, 2013
Last verified: February 2011

March 1, 2011
February 13, 2013
March 2011
May 2014   (final data collection date for primary outcome measure)
Incidence of CVD events [ Time Frame: 3 years ] [ Designated as safety issue: No ]

The CVD event is defined as composite of :

  • Acute myocardial infarction
  • Stroke
  • Cardiovascular death
Same as current
Complete list of historical versions of study NCT01307410 on ClinicalTrials.gov Archive Site
Annual incidence of microvascular complications [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Comprehensive Longitudinal Cohort Study in Type 2 Diabetes With High Risk of Cardiovascular Diseases in China
A Comprehensive Longitudinal Cohort Study in Type 2 Diabetes With High Risk of Cardiovascular Diseases in China - 3B Extension A Study of China Cardiometabolic Registries (CCMR)

In 2010, the sponsor conducted an observational study, entitled as "Nationwide Assessment of Cardiovascular Risk Factors: Blood Pressure, Blood Lipid, and Blood Glucose, in Chinese Patients with Type 2 Diabetes - 3B Study " which was to evaluate the level of cardiovascular diseases (CVD) risk factor control and its regional difference in China. As a continuation, this extension of the 3B Study is designed to assess the incidence of cardiovascular events, cardio-renal events, and other microvascular complications, in 1, 2 and 3 years in patients with type 2 diabetes and with high risk of (CVD) with or without existing or history of coronary artery diseases.

Limited by its cross sectional design, 3B study was not be able to provide any information on how various patterns of treatment and prescribing behaviors would impact the outcomes of prevention of cardiovascular and cardio-renal diseases in type 2 diabetes longitudinally. This information, however, would be crucial in better guiding the real world medical practice and maximizing the effectiveness of medical treatment for better controlling cardiovascular risk factors.

The 3B Extension study is thus designed to extend the 3B study by continuing to follow up on enrolled patients for 3 years. The 3B Extension study is expected to demonstrate the clinical outcomes of nationally representative type 2 diabetes patients who are treated by endocrinologists, cardiologists and nephrologists separately in all tiers of hospitals, as measured by diabetes progression, incidence of cardiovascular complications, and incidence of microvascular complications. It will be the first study of this scale in China based on its exclusivity, extensiveness, and the level of government and national thought leaders' support. It will be conducted in collaboration with the advisory board of China Cardiometabolic Registries (CCMR).

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with type 2 diabetes who previously participated in the 3B study from either community (tier 1), regional (tier 2), or teriary (tier 3) hospitals

Type 2 Diabetes
Not Provided
  • with CAD
    Patients with hypertension and dyslipidemia with prior CAD
  • without CAD
    Patients with hypertension and dyslipidemia without prior CAD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
5000
December 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 40 years or older
  • Outpatients who meet the inclusion and exclusion criteria of 3B study
  • With hypertension,dyslipidemia and one of the following:
  • History of acute coronary artery disease or ischemic stroke
  • Age > 65 years old
  • Overweight or obesity (BMI > 24 kg/m2)
  • Microalbuminuria or albuminuria
  • Current smoker

Exclusion Criteria:

  • Patients with type 1 DM
  • Pregnant or breast feeding women
  • Patients who are unable to or not willing to return for follow up visits every 6 months for 3 years;
  • Patients have severe heart failure (NYHA Class III-IV)
  • Patients with severe renal deficiency (creatinine clearance < 30 ml/min)
  • Patients who are not willing to sing the informed consent form;
  • Patients who are participating in any other interventional clinical studies,
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01307410
CCMR-303-3B Extension
No
China Cardiometabolic Registries
China Cardiometabolic Registries
  • Merck Sharp & Dohme Corp.
  • VitalStrategic Research Institute
  • Gerontological Society of China
  • Chinese Medical Doctor Association
Principal Investigator: Linong Ji, MD People's Hospital, Beijing University
Principal Investigator: Dayi Hu, MD People's Hospital, Beijing University
China Cardiometabolic Registries
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP