Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001204831
Ethics application status
Approved
Date submitted
28/07/2021
Date registered
9/09/2021
Date last updated
9/09/2021
Date data sharing statement initially provided
9/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Coronary Physiology and Imaging to Identify the Culprit Artery in Non-ST Elevation Myocardial Infarction: The CAPTURE-NSTEMI pilot study
Scientific title
Evaluating the diagnostic value of coronary physiology combined with optical coherence tomography in identifying the culprit lesion in adults presenting with non-ST elevation myocardial infarction
Secondary ID [1] 302095 0
None
Universal Trial Number (UTN)
Trial acronym
CAPTURE-NSTEMI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary heart disease 322986 0
Condition category
Condition code
Cardiovascular 320555 320555 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients presenting with non-ST elevation myocardial infarction (NSTEMI) and referred to the cardiac catheterization laboratory of two tertiary hospitals are eligible for recruitment. All patients will undergo cardiac magnetic resonance (CMR) prior to invasive coronary angiography (ICA) to identify the location of myocardial infarction. Contrast-enhanced CMR is performed with intravenous gadolinium, with cine and delayed enhancement imaging as per standard hospital protocols. Left ventricular function and volumes will be assessed by standard steady-state free precession technique. Short- and long-axis views will be acquired. Aortic flow maps will be acquired to confirm volumes. For contrast enhanced images, short-axis slices will be obtained by injecting 0.2 mmol/kg gadolinium at 2 mL/s followed by a 20 mL saline flush into an antecubital vein. Early gadolinium enhancement images are acquired 1-2 minutes after injection. Short axis stack images will be obtained. Late gadolinium enhancement images are acquired 10 minutes after contrast injection. Inversion time will be optimised to null normal myocardium. Left ventricular function, volumes and mass will be calculated. Microvascular obstruction is defined as an area of hypo-enhancement within the gadolinium hyper-enhanced area of infarcted tissue which is present early after contrast injection and persistent on late enhancement images. The CMR will take approximately 45 minutes and be performed in the radiology department of the hospital. The test is performed by an experienced radiographer under supervision of a qualified radiologist.

ICA is subsequently performed as per standard protocol. After ICA, all 3 major epicardial coronary arteries will be further interrogated with optical coherence tomography (OCT), fractional flow reserve (FFR), coronary flow reserve (CFR), the index of microcirculatory resistance (IMR), and plaque temperature. OCT is performed using the Dragonfly Optis Coronary optical coherence tomography system catheter as per standard hospital protocol. FFR, CFR, IMR, and plaque temperature are measured using the PressureWire X intravascular haemodynamic monitoring system guidewire as per standard hospital protocol. ICA, OCT, and coronary physiology measurements are performed in the cardiac catheter laboratory of the study hospital by an experienced interventional cardiologist. Total procedure time is expected to be approximately 75 minutes.

All patients will undergo the interventions mentioned above once during the course of the study. All interventions will take place on the same day within 24 hours of each other. All steps will be guided and tracked by an associate investigator using a checklist to monitor adherence.
Intervention code [1] 321262 0
Diagnosis / Prognosis
Comparator / control treatment
The ICA findings will act as the control against which the integrated OCT and physiology findings will be assessed.
Control group
Active

Outcomes
Primary outcome [1] 328408 0
Difference in correct identification of infarct-related artery between ICA findings alone vs integrated OCT/coronary physiology approach.
Timepoint [1] 328408 0
Immediately after performance of OCT and coronary physiology assessment
Secondary outcome [1] 398922 0
Change in revascularization strategy after disclosure of OCT and coronary physiology results. This information will be collected at the time of the index procedure by the investigators, or at the time of the multidisciplinary heart team review if indicated.
Timepoint [1] 398922 0
During index procedure or at the time of the multidisciplinary heart team review if indicated.
Secondary outcome [2] 399883 0
Change in revascularization strategy after disclosure of CMR results. This information will be collected at the time of the index procedure by the investigators, or at the time of the multidisciplinary heart team review if indicated.
Timepoint [2] 399883 0
During index procedure, or at the time of the multidisciplinary heart team review if indicated.

Eligibility
Key inclusion criteria
1) Patient age greater than or equal to 18 years, willing and able to give consent
2) NSTEMI defined as appropriate rise and fall of troponin, with at least one value above the 99th percentile and absence of ST-segment elevation, together with one of the following:
• Symptoms of myocardial ischemia
• New ischemic ECG changes
• Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Cardiogenic shock, defined as systolic blood pressure < 90mmHg, or need for inotropic support to maintain adequate blood pressure.
2) Previous MI
3) Previous coronary artery bypass grafting surgery or PCI
4) Glomerular filtration rate < 30 mL/min/1.73 m2
5) Contraindication to CMR
6) Contraindication to adenosine
7) Alternative explanation for troponin rise
8) Pregnancy
9) Excessive tortuosity of coronary vessels that precludes safe passage of pressure wire/OCT catheter
10) Ongoing symptoms/ischemia refractory to medical therapy, which necessitates urgent coronary angiography

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 50 patients are planned for this pilot study. Continuous variables are expressed as mean ± standard deviation for normally distributed data, and median (interquartile range) for non-normally distributed data. Categorical variables are expressed as frequencies (percentages). Logistic regression will be used to determine the odds ratio of various angiographic features (minimal luminal diameter, diameter stenosis, hazy or intraluminal filing defects, ulcers with overhanging edges, extraluminal contrast, and acute occlusion dissection), physiology values (FFR, CFR, and IMR), change in plaque temperature, and OCT features (minimal luminal area, plaque burden, plaque rupture, erosion, calcific nodule, and thrombus) in predicting the culprit lesion as adjudicated by CMR results.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/09/2021
Actual
Date of last participant enrolment
Anticipated
25/09/2023
Actual
Date of last data collection
Anticipated
29/09/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20095 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 20096 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 34803 0
2050 - Camperdown
Recruitment postcode(s) [2] 34804 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 306514 0
Hospital
Name [1] 306514 0
Royal Prince Alfred Hospital
Country [1] 306514 0
Australia
Funding source category [2] 309272 0
Commercial sector/Industry
Name [2] 309272 0
Abbott Vascular
Country [2] 309272 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
50 Missenden Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 310243 0
None
Name [1] 310243 0
Address [1] 310243 0
Country [1] 310243 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306718 0
Ethics Review Committee (RPAH Zone) of the Sydney Local Health District
Ethics committee address [1] 306718 0
Ethics committee country [1] 306718 0
Australia
Date submitted for ethics approval [1] 306718 0
01/02/2021
Approval date [1] 306718 0
15/07/2021
Ethics approval number [1] 306718 0

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

Contacts
Principal investigator
Name 104778 0
Prof Martin Ng
Address 104778 0
Royal Prince Alfred Hospital 50 Missenden Road, Camperdown, NSW 2050
Country 104778 0
Australia
Phone 104778 0
+61 2 9515 7110
Fax 104778 0
Email 104778 0
[email protected]
Contact person for public queries
Name 104779 0
Christopher Wong
Address 104779 0
Royal Prince Alfred Hospital 50 Missenden Road, Camperdown, NSW 2050
Country 104779 0
Australia
Phone 104779 0
+61 2 95156111
Fax 104779 0
Email 104779 0
[email protected]
Contact person for scientific queries
Name 104780 0
Christopher Wong
Address 104780 0
Royal Prince Alfred Hospital 50 Missenden Road, Camperdown, NSW 2050
Country 104780 0
Australia
Phone 104780 0
+61 2 95156111
Fax 104780 0
Email 104780 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All baseline characteristics, results of coronary angiogram and CMR, physiology and OCT measurements, outcomes.
When will data be available (start and end dates)?
23/08/2021 - 23/08/2029
Available to whom?
Available to journal reviewers and authors of meta-analyses if requested
Available for what types of analyses?
Reviews and meta-analyses
How or where can data be obtained?
Data can be obtained with reasonable requests to the authors and will be sent in individually unidentifiable form. Requests for data can be emailed to Dr Martin Ng ([email protected])


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.