Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000964910
Ethics application status
Not yet submitted
Date submitted
7/09/2011
Date registered
8/09/2011
Date last updated
8/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The correlative study of coronary risk factors by coronary computerized tomography angiography (CCTA) in a non-symptomatic and untreated population.
Scientific title
Compare the patients with coronary plague to the individuals with normal coronary artery detected by coronary computerized tomography angiography (CCTA) in a symptomless and untreated population to study correlation of coronary risk factors and the progression of coronary heart disease (CHD).
Secondary ID [1] 262998 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary heart disease 270730 0
Coronary plague in computerized tomography angiography 270731 0
Condition category
Condition code
Cardiovascular 270906 270906 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The prevalence and the correlation of coronary risk factors in a non-symptomatic and untreated population who received CCTA from Jan 1st 2010 to Jun 1st 2012 in a health exam center. If a patient underwent CCTA twice, compare these data to find the progression of CHD. The data of the past and futrure patients is stored in the Database of Chinese PLA General Hospital and retrieved by the Computer Department of Chinese PLA General Hospital.
Intervention code [1] 269345 0
Not applicable
Comparator / control treatment
No treatment or intervention is used in this observational study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279578 0
Detection of coronary artery plaque by coronary computerized tomography angiography(CCTA).
Timepoint [1] 279578 0
In 7 days after the patient revieved CCTA
Primary outcome [2] 279579 0
The proportion of the patients with abnormal coronary artery by CCTA in the non-symptomatic and untreated population.
Timepoint [2] 279579 0
1.On Apr 1st 2011 the result have been calculated for the first time.
2.At the end of the enrolment (Jan 1st 2012) the result will be calculated again.
Primary outcome [3] 279581 0
Correlation between coronary risk factors and coronary score by bivariant correlation,linear and logistic regression using IBM SPSS 19.01.
Timepoint [3] 279581 0
1.On Apr 1st 2011 the result have been calculated for the first time.
2.At the end of the enrolment (Jan 1st 2012) the result will be calculated again.
Secondary outcome [1] 287940 0
Frequency distribution of MIN score and another CCTA score design by our team.
MIN score is segment stemosis score, it based on the stegnosis of 16 segments in coronary artery, and the value is responding to the degree of coronary plagues in the patients with moderate or severe CHD. Our own score is similar to MIN score, but the density of plague is also concerned and is considered to have more sensitivity in the non-symptomatic and untreated population.
Timepoint [1] 287940 0
1.On Apr 1st 2011 the result have been calculated for the first time.
2.At the end of the enrolment (Jun 1st 2012) the result will be calculated again.
Secondary outcome [2] 287947 0
The distribution of plague in the early phase of coronary atherosclerosis.
Timepoint [2] 287947 0
1.On Apr 1st 2011 the result have been calculated for the first time.
2.At the end of the enrolment (Jun 1st 2012) the result will be calculated again.
Secondary outcome [3] 287948 0
The progression of coronary plague detected by CCTA
Timepoint [3] 287948 0
After 2 years after his/her enrollment if another CCTA is performed in the same patient.

Eligibility
Key inclusion criteria
1.Be hospitalized for health examination in our heathcare center during a consecutive period from Jan 1st 2010 to Jun 1st 2012
2.Undergo CCTA during his/her hospitalization
Minimum age
25 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Have any typical symptom of CHD
2.Have any medical history correlating with CHD
3.Have received anysystematic treatment

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment outside Australia
Country [1] 3829 0
China
State/province [1] 3829 0
Beijing

Funding & Sponsors
Funding source category [1] 269810 0
Government body
Name [1] 269810 0
Ministry of Science and Technology of the Peoples Republic of China
Country [1] 269810 0
China
Primary sponsor type
University
Name
Peaking University Health Science Center
Address
Xueyuan Road, Haidian district, Beijing, 100083
Country
China
Secondary sponsor category [1] 268844 0
Hospital
Name [1] 268844 0
Chinese PLA General Hospital
Address [1] 268844 0
Fuxing road, No.28, Beijing, 100853
Country [1] 268844 0
China

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 271773 0
Chinese PLA General Hospital of Ethics Committee
Ethics committee address [1] 271773 0
Fuxing road, No.28, Beijing, 100853
Ethics committee country [1] 271773 0
China
Date submitted for ethics approval [1] 271773 0
06/09/2011
Approval date [1] 271773 0
Ethics approval number [1] 271773 0

Summary
Brief summary
Coronary computerized tomography angiography (CCTA) is applied extensively in the big cities of China, even as an item of health examination. In this observational study, we want to investigate the proportion of the patients with abnormal coronary artery by CCTA in a non-symptomatic and untreated population, and the degree of their plagues. A statistical analysis is designed based on many items including laboratory examinations and ultrasound to find the correlation between coronary risk factors and coronary score in the early phase of coronary atherosclerosis. Additionally, the progression of CHD will be studied by comparing different data of CCTA in one patient.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33125 0
Address 33125 0
Country 33125 0
Phone 33125 0
Fax 33125 0
Email 33125 0
Contact person for public queries
Name 16372 0
Shuoyang Zhang
Address 16372 0
Fuxing road, No.28, Beijing, 100853
Country 16372 0
China
Phone 16372 0
+8618611609930
Fax 16372 0
Email 16372 0
zsy022@gmail.com
Contact person for scientific queries
Name 7300 0
Luyue Gai
Address 7300 0
Fuxing road, No.28, Beijing, 100853
Country 7300 0
China
Phone 7300 0
+861088628671
Fax 7300 0
Email 7300 0
Luyuegai301@yahoo.com.cn

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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