Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001335684
Ethics application status
Approved
Date submitted
25/11/2023
Date registered
19/12/2023
Date last updated
19/12/2023
Date data sharing statement initially provided
19/12/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
CT Coronary Angiography predictors of impaired blood supply to heart.
Scientific title
Association between vessel-specific Coronary AggregaTed Plaque Volume, Agatston score and hemodynamic significance of coronary disease in adults who have undergone an invasive coronary physiology.
Secondary ID [1] 311027 0
None
Universal Trial Number (UTN)
Trial acronym
The CAPTiVAte Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Disease 332144 0
Condition category
Condition code
Cardiovascular 328867 328867 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a retrospective observational study. The procedural database at two tertiary centres are reviewed for patients who had invasive angiography with subsequent FFR between January 2014 and December 2022. The CTCA database was subsequently reviewed for CTCA studies performed within 2 months of the FFR procedure. The FFR procedure was performed using standard protocol, including administering intra-coronary glyceryl trinitrate (50-200mcg) and normalising the pressure wire, the wire was inserted at least 2cm distal to the most distal visible plaque, and hyperaemia induced by intravenous adenosine (140–180 µg/kg/min) or intra-coronary adenosine bolus (200-400mcg). FFR less than or equal to 0.80 was considered ischaemic.

Automated software (CT SUREPlaque, Vitrea AV Version 7.14.6; Canon Medical Informatics and Canon Medical Systems Corporation) will perform automated plaque analysis, including the aggregated plaque volume (APV) and maximal area/diameter stenosis. Volumes of plaque subtypes are also obtained through the software, using pre-specified definitions of Low Attenuation Plaque (LAP), Non-Calcific Plaque (NCP) and Calcific Plaque (CP), according to consensus guidelines. LAP was defined as plaque with attenuation <30 Hounsfield units (HU). NCP was defined as attenuation between 30-150 HU, and CP was defined as attenuation >150 HU. Aggregated Plaque Burden (APB) was calculated as aggregated plaque volume/vessel volume (APV/VV) x 100. Subtypes of plaque burden, including CP burden (CPB), LAP burden (LAPB), and NCP burden (NCPB) were defined as plaque subtype volume as a percentage of overall plaque volume. Volumes of plaque subtypes included CP volume (CPV), LAP volume (LAPV) and NCP volume (NCPV). These assessments are performed by a cardiologist. These assessments are performed at the clinical campus where these tests are performed (including Royal North Shore Hospital and North Shore Private Hospital). There are no follow up requirements in this study, therefore there is no duration of observation. There are two encounters which have occurred as part of routine clinical care in this study, which is the CTCA and the invasive angiogram with subsequent FFR.

The software used in this project can be used for clinical purposes, and is validated, however is not used as part of routine clinical care, and used only for participants of this study.
The study will include 150-200 patients.
Intervention code [1] 327477 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336665 0
Vessel-specific aggregated plaque burden
Timepoint [1] 336665 0
At the time of the CTCA.
Secondary outcome [1] 429269 0
Vessel-specific Agatston score
Timepoint [1] 429269 0
At the time of the coronary calcium score study

Eligibility
Key inclusion criteria
- More than 18 years of age
- Have had an invasive angiogram with pressure wire investigation performed on the LAD artery.
- Has had a CTCA performed using a 64-slice CT scanner.
- FFR performed within 2 months of CTCA
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Inaccurate segmentation of vessel using CTCA
- Inaccurate fractional flow reserve study.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/06/2023
Date of last participant enrolment
Anticipated
Actual
6/10/2023
Date of last data collection
Anticipated
Actual
10/10/2023
Sample size
Target
220
Accrual to date
Final
145
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315289 0
Self funded/Unfunded
Name [1] 315289 0
In-kind support from hours of unpaid staff time allocated to this project.
Country [1] 315289 0
Primary sponsor type
Hospital
Name
Northern Sydney Local Health District
Address
Reserve Rd, St Leonards, NSW 2065
Country
Australia
Secondary sponsor category [1] 317330 0
None
Name [1] 317330 0
Address [1] 317330 0
Country [1] 317330 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314213 0
Northern Sydney Local Health District Human Research Ethics Committe
Ethics committee address [1] 314213 0
Ethics committee country [1] 314213 0
Australia
Date submitted for ethics approval [1] 314213 0
27/01/2023
Approval date [1] 314213 0
20/03/2023
Ethics approval number [1] 314213 0
2022/ETH02756

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130802 0
Dr Avedis Ekmejian
Address 130802 0
Department of Cardiology, Level 5, Royal North Shore Hospital, Reserve Rd, St Leonards, NSW 2065.
Country 130802 0
Australia
Phone 130802 0
+61439996344
Fax 130802 0
Email 130802 0
aekmejian@hotmail.com
Contact person for public queries
Name 130803 0
Avedis Ekmejian
Address 130803 0
Department of Cardiology, Level 5, Royal North Shore Hospital, Reserve Rd, St Leonards, NSW 2065.
Country 130803 0
Australia
Phone 130803 0
+61439996344
Fax 130803 0
Email 130803 0
aekmejian@hotmail.com
Contact person for scientific queries
Name 130804 0
Avedis Ekmejian
Address 130804 0
Department of Cardiology, Level 5, Royal North Shore Hospital, Reserve Rd, St Leonards, NSW 2065.
Country 130804 0
Australia
Phone 130804 0
+61439996344
Fax 130804 0
Email 130804 0
aekmejian@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data is completely de-identified and not available for public viewing


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.