Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000368932
Ethics application status
Not yet submitted
Date submitted
5/04/2011
Date registered
11/04/2011
Date last updated
11/04/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Revascularization of chronic total occlusion under the guidance of mobile CT workstation
Scientific title
Revascularization of chronic total occlusion under the guidance of mobile CT workstation
Secondary ID [1] 259918 0
Nil
Universal Trial Number (UTN)
U1111-1120-5329
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic total occlusion (CTO) 265525 0
Computed tomography angiography 265575 0
Condition category
Condition code
Cardiovascular 265682 265682 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Design: The patients with CTO by computed tomography angiography (CCTA ) are randomly divided into 2 groups. The group 1 consists of patients who are examined by CCTA and our dedicated mobile work station. The station has the capability of reconstruction of acquired CT image and manipulate the images so as to allow the interventional cardiologist better interpret findings. The following indices are calculated: the length of the occlusion, the degree of the calcification and the characteristics of the occlusion. The most important step is to puncture the occluded artery with various guide wire. Always keep the wire at the center of the occlude artery. The procedure usually takes 2 hours. The patients can be discharged within 7 days. The follow-up is routine but not mandatory.
Intervention code [1] 264341 0
Treatment: Devices
Intervention code [2] 264362 0
Treatment: Surgery
Comparator / control treatment
The group 2 consists of patients who are examined by CCTA only. The operators know the basic knowledge of CCTA but have no idea how to operate the mobile work station. They use conventional method to recanalize the occluded artery. The group 3 consists of patients who are diagnosed by CAG as CTO. They usThe procedure usually takes 2 hours. The patients can be discharged within 7 days. The follow-up is routine but not mandatory. e conventional method to recanalize the occluded artery.
Control group
Active

Outcomes
Primary outcome [1] 266459 0
Recannalization of CTO is documented by CAG
Timepoint [1] 266459 0
7 days
Primary outcome [2] 266460 0
Any adverse events during the hospital stay, including AMI, death, cardiac tamponade and pulmonary edema.
Timepoint [2] 266460 0
7 days
Secondary outcome [1] 273817 0
procedure time (minutes)
Timepoint [1] 273817 0
7 days
Secondary outcome [2] 273818 0
fluoroscopy time (minutes)
Timepoint [2] 273818 0
7 days
Secondary outcome [3] 273866 0
contras (ml)
Timepoint [3] 273866 0
7 days
Secondary outcome [4] 273867 0
number of guidewire
Timepoint [4] 273867 0
7 days
Secondary outcome [5] 273868 0
number of balloons
Timepoint [5] 273868 0
7 days

Eligibility
Key inclusion criteria
1. CTO is arbitrarily defined as a > 3 month old, total obstruction of a coronary artery.
2. The patients have undergone both CAG and CCTA.
Minimum age
25 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Heart falure, NYHA>3, AMI, severe renal dysfuction, stroke with hemiplegia, left main disease >75%, EF <35%

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
coin-tossing and dice-rolling
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 3338 0
China
State/province [1] 3338 0
Beijing

Funding & Sponsors
Funding source category [1] 264814 0
Government body
Name [1] 264814 0
Ministry of Science and Technology of the Peoples Republic of China
Country [1] 264814 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] 263921 0
Hospital
Name [1] 263921 0
Chinese PLA General Hospital
Address [1] 263921 0
Fuxing road, No.28, Beijing, 100853
Country [1] 263921 0
China

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266785 0
Chinese PLA General Hospital of Ethics Committee
Ethics committee address [1] 266785 0
Fuxing road, No.28, Beijing, 100853
Ethics committee country [1] 266785 0
China
Date submitted for ethics approval [1] 266785 0
05/05/2011
Approval date [1] 266785 0
Ethics approval number [1] 266785 0

Summary
Brief summary
This is an interventional study. The study is investigating the possibility of using a mobile CT work station technique to increase the CTO recanalization rate. Conventional CAG is used as a control. Visual estimate by CCTA is used as a second control. We hypothesize that the mobile CT work station might improve the recanalization rate.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32439 0
Address 32439 0
Country 32439 0
Phone 32439 0
Fax 32439 0
Email 32439 0
Contact person for public queries
Name 15686 0
Luyue Gai
Address 15686 0
Fuxing road, No.28, Beijing, 100853
Country 15686 0
China
Phone 15686 0
861088628671
Fax 15686 0
Email 15686 0
[email protected]
Contact person for scientific queries
Name 6614 0
Luyue Gai
Address 6614 0
Fuxing road, No.28, Beijing, 100853
Country 6614 0
China
Phone 6614 0
861088628671
Fax 6614 0
Email 6614 0
[email protected]

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
SourceTitleYear of PublicationDOI
Dimensions AIComparison of coronary angiography-assisted and computed coronary tomography angiography-assisted recanalisation of coronary chronic total occlusion2013https://doi.org/10.1136/heartasia-2013-010302
N.B. These documents automatically identified may not have been verified by the study sponsor.