Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001591842
Ethics application status
Approved
Date submitted
7/09/2021
Date registered
22/11/2021
Date last updated
24/10/2022
Date data sharing statement initially provided
22/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of Epicardial plaQUe composition and geometry on coronary
hemodynamics and flow (iEquate)
Scientific title
Impact of Epicardial plaQUe composition and geometry on coronary
hemodynamics and flow in patients with coronary artery disease.
Secondary ID [1] 305252 0
None
Universal Trial Number (UTN)
U1111-1269-2768
Trial acronym
iEquate
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 323526 0
Condition category
Condition code
Cardiovascular 321084 321084 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Consent for the research project will be obtained before undergoing the coronary angiogram. The angiogram is administered outside the study (meaning that the patient has a clinical indication for the angiogram, including angina). The angiogram is performed by a cardiologist and the associated cardiology team, who assess the results. A diagnostic angiogram usually takes between 15-20 minutes. Patients who are subsequently identified to have moderate (50-75%) stenosis angiographically undergo invasive hemodynamic assessments using 0.014 inch pressure wire. This is performed as part of routine best clinical practice to determine need for percutaneous coronary intervention, using the hospital protocol for pressure wire assessments, and occurs immediately following the diagnostic angiogram. This is performed by the interventional cardiologist or the interventional cardiology fellow. This involves FFR (Fractional Flow Reserve) and iFR (instantaneous wave-free ratio) which can be performed using the same wire, without the need for re-instrumentation of the coronary artery. The standard procedural protocol would be applied, with pharmacological stress or exercise-induced stress (using an Ergometer) used to stimulate hyperaemia within the artery in order to obtain pressure wire assessments. All hemodynamic values will be recorded. In total, invasive hemodynamic assessments add no more than 15 minutes to the diagnostic angiogram. If a patient has consented to the research project before undergoing the coronary angiogram, and are found to have moderate stenosis, an OCT catheter will be passed over the coronary wire to obtain intra-vascular imaging and plaque composition assessment. On average, this adds 3-4 minutes to the standard hemodynamic assessments. Following the procedure, patients are recovered for a total of 4 hours with cardiac monitoring, as per post-procedural protocol. No additional requirements are necessary for the recovery as a result of participation in this study. Data will be collected on the minimal luminal area (MLA), plaque geometry (irregularity/angulation/length), degree of calcification, fibroatheroma, necrotic core, and lipid content. These variables will be examined in terms of relationship to the pressure wire value. If the lesion meets hemodynamic significance (i.e. iFR value less than or equal to 0.89 or FFR value less than or equal to 0.8). Percutaneous Coronary Intervention (PCI) may be performed if clinically suitable as per usual clinical practice.

All involved medical staff will be briefed by a member of the research team, and data logged in a secure password-encrypted database.
Intervention code [1] 321642 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328868 0
FFR (Fractional Flow Reserve) assess using coronary pressure wire.
Timepoint [1] 328868 0
Immediately post pressure wire assessment.
Primary outcome [2] 328869 0
Geometric characteristics of plaque assessed by OCT catheter.
Timepoint [2] 328869 0
Immediately post-OCT catheter assessment.
Primary outcome [3] 329428 0
iFR (Instantaneous Wave-Free Ratio) assess using coronary pressure wire.
Timepoint [3] 329428 0
Immediately post pressure wire assessment.
Secondary outcome [1] 400682 0
Complex plaque geometry causing iFR/FFR disconcordance, assessed using OCT catheter.
Timepoint [1] 400682 0
Immediately post OCT catheter procedure.
Secondary outcome [2] 400683 0
Calcium causing iFR/FFR disconcordance, Calcium is assessed using OCT image acquisition and analysis. iFR/FFR disconconcordance is assessed using the pressure wire.
Timepoint [2] 400683 0
Immediately post-OCT catheter procedure.
Secondary outcome [3] 402564 0
- minimal luminal area (MLA) assessed by OCT catheter.
Timepoint [3] 402564 0
- Immediately post-OCT assessment.
Secondary outcome [4] 402565 0
Fibroatheroma assessed by OCT
Timepoint [4] 402565 0
Immediately post OCT assessment.
Secondary outcome [5] 402566 0
Necrotic core assessed by OCT.
Timepoint [5] 402566 0
Immediately post OCT assessment.
Secondary outcome [6] 402567 0
Lipid content assessed by OCT
Timepoint [6] 402567 0
Immediately post OCT assessment.

Eligibility
Key inclusion criteria
1. Age more than or equal to 18 years
2. Undergoing clinically indicated coronary angiogram.
3. Moderate coronary lesion (50-75%) in an epicardial vessel more than or equal to 2mm.
4. Willingness to give written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Clinical instability at time of procedure.
2. Difficulty in passing device passed the coronary lesion.
3. Plaque determined to be unstable angiographically by the operator.
4. Renal impairment with GFR <25 ml/min/1.73m2
5. Impairment of left ventricular systolic function EF <25%
6. Severe aortic stenosis (mean gradient >40mmHg)

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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
30/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20484 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 20485 0
North Shore Private Hospital - St Leonards
Recruitment postcode(s) [1] 35257 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 309620 0
Commercial sector/Industry
Name [1] 309620 0
ABBOTT MEDICAL AUSTRALIA PTY LTD
Country [1] 309620 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Reserve Rd, St Leonards
NSW 2065
Country
Australia
Secondary sponsor category [1] 310635 0
None
Name [1] 310635 0
Address [1] 310635 0
Country [1] 310635 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309394 0
Northern Sydney Local Health District HREC
Ethics committee address [1] 309394 0
Level 13, Kolling Building, Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065
Ethics committee country [1] 309394 0
Australia
Date submitted for ethics approval [1] 309394 0
Approval date [1] 309394 0
19/07/2021
Ethics approval number [1] 309394 0
2021/STE02078
Ethics committee name [2] 309396 0
Ramsay Health Care NSW | VIC HREC
Ethics committee address [2] 309396 0
Level 3/5 Talavera Rd, Macquarie Park NSW 2113
Ethics committee country [2] 309396 0
Australia
Date submitted for ethics approval [2] 309396 0
Approval date [2] 309396 0
21/06/2021
Ethics approval number [2] 309396 0

Summary
Brief summary
After informed consent, patient’s undergoing coronary angiography
who have moderate (50-75%) stenosis angiographically would
undergo invasive hemodynamic assessments via a 0.014 inch
coronary wire as part of routine clinical practice to determine need for
percutaneous coronary intervention. Further to this, over the pressure
wire, an optical coherence tomography (OCT) catheter would be
passed to obtain intra-vascular imaging and plaque composition
assessment. Data will be collected on the minimal luminal area (MLA),
degree of calcification, fibroatheroma, necrotic core, lipid content and
the geometry of the lesion. These variables will be examined in terms
of relationship to the pressure wire value. If the lesion meets
hemodynamic significance (i.e. iFR value less than or equal to 0.89 or FFR value less than or equal to 0.8).
PCI may be performed if clinically suitable as per usual clinical practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114002 0
Prof Ravinay Bhindi
Address 114002 0
Deparment of Cardiology
Level 5, Royal North Shore Hospital
Reserve Rd, St Leonards
NSW 2065
Country 114002 0
Australia
Phone 114002 0
+61 416005737
Fax 114002 0
Email 114002 0
[email protected]
Contact person for public queries
Name 114003 0
Dr Avedis Ekmejian
Address 114003 0
Deparment of Cardiology
Level 5, Royal North Shore Hospital
Reserve Rd, St Leonards
NSW 2065
Country 114003 0
Australia
Phone 114003 0
+61 299267111
Fax 114003 0
Email 114003 0
[email protected]
Contact person for scientific queries
Name 114004 0
Dr Avedis Ekmejian
Address 114004 0
Deparment of Cardiology
Level 5, Royal North Shore Hospital
Reserve Rd, St Leonards
NSW 2065
Country 114004 0
Australia
Phone 114004 0
+61 299267111
Fax 114004 0
Email 114004 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13117Informed consent form    382736-(Uploaded-07-09-2021-14-46-22)-Study-related document.doc
13118Study protocol    382736-(Uploaded-10-10-2021-13-18-37)-Study-related document.docx
13120Ethical approval    382736-(Uploaded-07-09-2021-14-47-19)-Study-related document.pdf


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13117Informed consent form    382736-(Uploaded-07-09-2021-14-46-22)-Study-related document.doc
13118Study protocol    382736-(Uploaded-08-02-2024-09-01-41)-Study-related document.docx
13120Ethical approval    382736-(Uploaded-08-02-2024-09-00-24)-Study-related document.docx

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.