Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001682831
Ethics application status
Approved
Date submitted
30/10/2021
Date registered
9/12/2021
Date last updated
9/12/2021
Date data sharing statement initially provided
9/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Correlating invasive and non-invasive measures of coronary flow in patients with angina
Scientific title
Correlation of single-photon emission computed
tomography myocardial flow reserve imaging with invasively measured epicardial and microvascular coronary haemodynamics in adults with angina
Secondary ID [1] 305698 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CORRELATE MFR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary microvascular dysfunction 324172 0
Condition category
Condition code
Cardiovascular 321645 321645 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
The study aims to assess the correlation between single proton emission computed tomography/computed tomography (SPECT/CT) myocardial flow reserve with invasive coronary flow reserve in patients with both normal coronary angiography and intermediate lesions (intermediate lesions are those with 50-70% stenosis severity) on coronary angiography warranting further investigation.
Patients will be recruited immediately prior to coronary angiography indicated for the investigation of ischaemic chest pain and either (1) normal epicardial vessels but symptoms suggestive of myocardial ischaemia, or (2) abnormal single epicardial vessel on coronary angiography with lesions of indeterminate significance warranting further evaluation with functional investigations prior to a decision regarding percutaneous revascularisation. The aim will be to recruit 20 patients in each group. Patients in group 1 will have invasive coronary flow reserve (CFR)/index of microvascular resistance (IMR) measures in their left anterior descending and right coronary arteries. Patients in group 2 will have fractional flow reserve (FFR), CFR and IMR performed in the vessel containing the lesion along with the non-culprit vessel (left anterior descending or right coronary artery). All patients will then have SPECT/CT scans within 7 days of their coronary angiogram, with assessment of SPECT-coronary flow reserve.
The CFR, IMR and FFR assessments will be performed as a 10-15 minute additional assessment as part of their clinically indicated coronary angiogram which takes place as a day procedure. The CFR and IMR assessments are specific to the study, the FFR would be performed as part of clinical practice. These assessments will be performed according to protocols used by local hospital cardiologists for all such assesments in clinical and research studies. The SPECT/CT scan will require an additional 1-2 hour visit to the hospital. It is an additional assessment which would not routinely be performed for these patients but which may provide additional clinically relevant information. The SPECT/CT scan will be performed according to local hospital protocol.
The correlation between these investigations will be assessed. Additionally, patients will be contacted at 30 days and 12 months by the study investigators to enquire about outcomes, particularly major adverse cardiac events; ongoing symptoms attributable to myocardial ischaemia; and further investigations/diagnoses made subsequent to the invasive and SPECT myocardial flow reserve studies.
Intervention code [1] 322087 0
Diagnosis / Prognosis
Comparator / control treatment
There will be no comparator/control group - the aim of the study is to investigate how well the two investigations correlate.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329419 0
Level of agreement between invasive and SPECT/CT myocardial flow reserve based on Pearson coefficient when assessing invasive coronary flow reserve against SPECT/CT myocardial flow reserve.
Timepoint [1] 329419 0
Assessed at the conclusion of the study.
Secondary outcome [1] 402531 0
Effect of invasive results on MACE, symptoms, and diagnoses made or further investigations organised.
Timepoint [1] 402531 0
12 months after enrolment in the study.
Secondary outcome [2] 403311 0
Effect of SPECT/CT results on MACE, symptoms, and diagnoses made or further investigations organised.
Timepoint [2] 403311 0
12 months after conclusion of enrolment
Secondary outcome [3] 403312 0
Sensitivity and specificity of SPECT/CT for the identification of abnormal myocardial flow reserve as determined by the gold standard, invasive coronary flow reserve. A receiver operator characteristic analysis will be performed to determine this.
Timepoint [3] 403312 0
At the conclusion of recruitment.

Eligibility
Key inclusion criteria
Patients referred for coronary angiography for investigation of ischaemic chest pain. Inclusion criteria for group 1 is that they have normal epicardial vessels (<30% diameter stenosis) who will undergo invasive coronary flow reserve (CFR) and index of microvascular resistance (IMR) at the time of coronary angiogram.
Inclusion criteria for group 2 is that they have a moderate-severe lesion on coronary angiogram in either the RCA or LAD, who will undergo fractional flow reserve (FFR), CFR and IMR in both the culprit and non-culprit vessel.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with a rise in high-sensitivity troponin I in concert with their ischaemic symptoms
- Pregnant and breastfeeding women, due to the radiation exposure inherent to this study
- Patients with allergies to iodine contrast
- Patients with contraindications to adenosine including: asthma/bronchospasm, greater than first degree heart block or sick sinus syndrome without a pacemaker, symptomatic aortic stenosis or hypertrophic cardiomyopathy, hypotension (SBP < 90 mmHg), unstable angina, cerebral ischaemia or current dipyridamole medication use.
- Patients with previous evidence of myocardial infarction (such as history of STEMI, NSTEMI) or baseline perfusion abnormalities on SPECT to suggest previous myocardial infarction given it may impact the measurements of FFR/CFR/IMR).

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This study will correlate the results of the two investigative measures and additionally detail the sensitivity and specificity of SPECT/CT MFR for the identification of coronary microvascular disease as identified by the gold standard invasive measurement. Receiver-operating-characteristic (ROC) curve analysis will be performed to evaluate the ability of the SPECT/CT scans to predict micro and macrovascular disease. Furthermore, the relationship between each MFR technique and outcome measures will be assessed with the Cox proportional hazards method.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/12/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 35835 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 310059 0
Hospital
Name [1] 310059 0
The Alfred Hospital
Country [1] 310059 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Abbott Vascular
Address
666 Doncaster Rd
Doncaster
VIC
3108
Country
Australia
Secondary sponsor category [1] 311110 0
None
Name [1] 311110 0
None
Address [1] 311110 0
Country [1] 311110 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309750 0
Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 309750 0
55 Commercial Rd
Melbourne
VIC
3004
Ethics committee country [1] 309750 0
Australia
Date submitted for ethics approval [1] 309750 0
Approval date [1] 309750 0
23/07/2020
Ethics approval number [1] 309750 0
HREC/64654/Alfred-2020

Summary
Brief summary
The aim of this study is to compare invasive (meaning it is done from inside the body) assessment of blood flow through the large and small arteries of the heart to the heart muscle (via angiography) and a single proton emission computed tomography with low dose CT (SPECT/CT) scan assessing the same thing.
This is because SPECT/CT assessment of blood flow to the heart through small arteries is a relatively new technology that we would like use more if the results of this study deem it to be accurate. Presently it is difficult to assess whether there are abnormalities of the small arteries of the heart, which is a common cause of chest pain in people who are diagnosed as having “normal coronary arteries”. The only way to do this currently is with an invasive test, using special pressure wires to measure blood flow in the small arteries.

This would mean that patients with chest pain could have a SPECT/CT scan alone rather than an angiogram (requiring a procedure with inherent risks) to investigate their symptoms.

Involvement in this study involves addition of a pressure wire test to the normal heart angiogram procedure, along with a SPECT/CT scan. Additionally, participants will be checked in on at 1 and 12 months following their tests to assess their progress, whether they have had any heart problems, how their symptoms are, and whether they have had any further tests or diagnoses. This will all help to assess how useful the SPECT/CT scan will be in the future.
Trial website
NA
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 115262 0
Dr A/Prof William Chan
Address 115262 0
The Heart Centre
The Alfred Hospital
55 Commercial Rd
Melbourne VIC 3004
Country 115262 0
Australia
Phone 115262 0
+61 390762000
Fax 115262 0
Email 115262 0
william.chan@unimelb.edu.au
Contact person for public queries
Name 115263 0
Dr David Nadebaum
Address 115263 0
Nuclear Medicine Department
The Alfred Hospital
55 Commercial Rd
Melbourne VIC 3004
Country 115263 0
Australia
Phone 115263 0
+61 3 90762000
Fax 115263 0
Email 115263 0
d.nadebaum@alfred.org.au
Contact person for scientific queries
Name 115264 0
Dr A/Prof William Chan
Address 115264 0
The Heart Centre
The Alfred Hospital
55 Commercial Rd
Melbourne VIC 3004
Country 115264 0
Australia
Phone 115264 0
+61 390762000
Fax 115264 0
Email 115264 0
william.chan@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The small sample size and potentially identifiable nature of the data due to this will preclude IPD sharing


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13875Ethical approval    383051-(Uploaded-30-10-2021-15-48-08)-Study-related document.pdf
13876Informed consent form    383051-(Uploaded-23-11-2021-08-33-42)-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.