ANZCTR - Registration

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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]

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

Condition category

Condition code

Cardiovascular

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]

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]

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]

Assessed at the conclusion of the study.

Secondary outcome [1]

Effect of invasive results on MACE, symptoms, and diagnoses made or further investigations organised.

Timepoint [1]

12 months after enrolment in the study.

Secondary outcome [2]

Effect of SPECT/CT results on MACE, symptoms, and diagnoses made or further investigations organised.

Timepoint [2]

12 months after conclusion of enrolment

Secondary outcome [3]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Alfred Hospital

Address [1]

55 Commercial Rd
Melbourne
VIC
3004

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Abbott Vascular

Address

666 Doncaster Rd
Doncaster
VIC
3108

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Human Research Ethics Committee

Ethics committee address [1]

55 Commercial Rd
Melbourne
VIC
3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

23/07/2020

Ethics approval number [1]

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

Dr A/Prof William Chan

Address

The Heart Centre
The Alfred Hospital
55 Commercial Rd
Melbourne VIC 3004

Country

Australia

Phone

+61 390762000

Fax

william.chan@unimelb.edu.au

Contact person for public queries

Name

David Nadebaum

Address

Nuclear Medicine Department
The Alfred Hospital
55 Commercial Rd
Melbourne VIC 3004

Country

Australia

Phone

+61 3 90762000

Fax

d.nadebaum@alfred.org.au

Contact person for scientific queries

Name

A/Prof William Chan

Address

The Heart Centre
The Alfred Hospital
55 Commercial Rd
Melbourne VIC 3004

Country

Australia

Phone

+61 390762000

Fax

william.chan@unimelb.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
13875	Ethical approval					383051-(Uploaded-30-10-2021-15-48-08)-Study-related document.pdf
13876	Informed 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.

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