Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000060448
Ethics application status
Approved
Date submitted
14/12/2015
Date registered
20/01/2016
Date last updated
20/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Imaging of coronary sinus anatomy via late venous phase coronary angiography.
Scientific title
Imaging of coronary sinus anatomy via late venous phase coronary angiography in adult non emergency angiography patients assessing effectiveness of coronary sinus imaging for cardiac interventions such as left ventricular lead placement in cardiac resynchronisation therapy/biventricular pacing.
Secondary ID [1] 288150 0
Nil Known
Universal Trial Number (UTN)
U1111-1177-6393
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure 297060 0
Condition category
Condition code
Cardiovascular 297288 297288 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Angiography is the x-ray imaging of blood vessels using a substance injected into the blood stream showing the blood vessels in the heart. Late venous phase coronary angiography includes using a longer (3-5seconds) fluoroscopy sequence after contrast media injection performed by the cardiologist. Angiography would take less than an hour (typically 30-45 minutes) and this trial will only add 3 to 5 seconds more.

This scan takes place immediately following injection of contrast media.
A catheter is inserted into the forearm and is then threaded up through to the major coronary artery by the cardiologist. The contrast media is then administered through this catheter immediately prior to the x-ray image being taken
Intervention code [1] 293460 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296867 0
We are assessing the effectiveness of venous phase coronary angiography coronary sinus imaging to successfully provide satisfactory imaging of the coronary sinus and its tributaries for cardiac interventions such as left ventricular lead placement in cardiac resynchronisation therapy/biventricular pacing.

Satisfactory imaging is defined as successfully being able to visualise the coronary sinus for placement of left ventricular lead placement.
Timepoint [1] 296867 0
At or on the day off the time of the single late venous phase coronary angiography image.'
Secondary outcome [1] 319557 0
Relationships between factors (ie. age, gender etc.) and the anatomy/visualisation of coronary sinus and its tributaries. This will be assessed using data linkage to medical records.
Timepoint [1] 319557 0
Following the single late venous phase coronary angiography image.

Eligibility
Key inclusion criteria
Adult patients
Fiona Stanley Hospital ­ tertiary metropolitan hospital
Undergoing angiography for any indication not listed in the exclusions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
May include conditions that increase the risk to the participant,
that interfere with the participants ability to give informed consent or interfere with a
participant’s ability to comply.
*Emergency procedure (eg. ST segment elevation myocardial infarction (STEMI));
*Pregnancy;
*Age < 18 years of age;
*Inability to provide informed consent;
*Creatinine clearance < 45ml/min.
*Patient does not consent to the study.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/01/2016
Actual
Date of last participant enrolment
Anticipated
20/01/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4953 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 12452 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 292560 0
Self funded/Unfunded
Name [1] 292560 0
N/A
Country [1] 292560 0
Primary sponsor type
Individual
Name
Dr Christopher Judkins
Address
Fiona Stanley Hospital
102-118 Murdoch Dr, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 291280 0
None
Name [1] 291280 0
None
Address [1] 291280 0
None
Country [1] 291280 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294036 0
WA Health Ethics
Ethics committee address [1] 294036 0
Ethics committee country [1] 294036 0
Australia
Date submitted for ethics approval [1] 294036 0
Approval date [1] 294036 0
14/12/2015
Ethics approval number [1] 294036 0
15­-159

Summary
Brief summary
The research team aims to investigate the use of venous phase coronary angiography to visualise the coronary sinus and tributary vessels in patients who are having a standard coronary angiogram and that are not having CRT implantation. We hypothesise that this imaging will enhance knowledge of CS anatomy and pathology; and that this knowledge will assist both this specific patient population (if needing CRT in the future), and other
general populations from a greater understanding and better planning of CRT lead placements.

We seek to prove that venous phase coronary angiography CS imaging is able to successfully provide satisfactory imaging of the coronary sinus and its tributaries for cardiac interventions such as left ventricular lead placement in cardiac resynchronisation therapy/biventricular pacing.
We also seek to determine relationships between factors (ie. age, gender etc.) and the
anatomy/visualisation of coronary sinus and its tributaries.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62198 0
Dr Christopher Judkins
Address 62198 0
Fiona Stanley Hospital
102-118 Murdoch Dr, Murdoch WA 6150
Country 62198 0
Australia
Phone 62198 0
+61 8 6152 2222
Fax 62198 0
Email 62198 0
[email protected]
Contact person for public queries
Name 62199 0
Dr Samuel Ognenis
Address 62199 0
Fiona Stanley Hospital
102-118 Murdoch Dr, Murdoch WA 6150
Country 62199 0
Australia
Phone 62199 0
+61 8 6152 2222
Fax 62199 0
Email 62199 0
[email protected]
Contact person for scientific queries
Name 62200 0
Dr Christopher Judkins
Address 62200 0
Fiona Stanley Hospital
102-118 Murdoch Dr, Murdoch WA 6150
Country 62200 0
Australia
Phone 62200 0
+61 8 6152 2222
Fax 62200 0
Email 62200 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
No additional documents have been identified.