Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001263886
Ethics application status
Approved
Date submitted
19/07/2021
Date registered
17/09/2021
Date last updated
17/09/2021
Date data sharing statement initially provided
17/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A comprehensive assessment of coronary physiology in cardiogenic shock.
Scientific title
A comprehensive invasive assessment of coronary physiology in adult patients with cardiogenic shock
Secondary ID [1] 304821 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CORSHOCK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiogenic shock 322887 0
Condition category
Condition code
Cardiovascular 320470 320470 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
It is our aim to characterise coronary and microcirculatory physiology in cardiogenic shock of differing aetiologies and in patients receiving various haemodynamic support strategies. Invasive coronary physiologic assessment will be performed using a 0.014-inch pressure/temperature-tipped angioplasty guidewire (PressureWire Certus or PressureWireX, manufactured by Abbott). This will be performed following routine coronary angiography (and percutaenous coronary intervention, if performed), while the patient is attending the catheterisation laboratory. Patients included will be those requiring haemodynamic support, which may include inotropes, VA ECMO, or Impella. Measurements will be perfomed whilst in the catheterisation laboratory (over a period of approximately 20 minutes) at baseline support and at 50% reduction in haemodynamic support (i.e VA ECMO flows reduced by 50%).
Intervention code [1] 321196 0
Diagnosis / Prognosis
Comparator / control treatment
Mechanical ciruclatory support patients will be compared to patients receiving inotropic support (i.e no mechanical supports)
Control group
Active

Outcomes
Primary outcome [1] 328306 0
Index of microcirculatory resistance (IMR) using an angioplasty wire.
Timepoint [1] 328306 0
At the time of physiology measurements being obtained
Primary outcome [2] 328560 0
Fractional flow reserve (FFR) using an angioplasty wire.
Timepoint [2] 328560 0
At time of index coronary angiogram
Primary outcome [3] 328561 0
Coronary flow reserve (CFR) using an angioplasty wire.
Timepoint [3] 328561 0
At time of index angiogram
Secondary outcome [1] 398504 0
Change in coronary perfusion with haemodynamic support ramping.
Timepoint [1] 398504 0
At the time of coronary physiology assessment. The will be determined using a coronary pressure wire and the Coroventis/Coroflow system.

Eligibility
Key inclusion criteria
1. Ages of 18 and above.
2. Coronary angiography being undertaken as part of routine patient care as determined by the treating team.
3. SCAI Shock stage C or less
4.Onset of symptoms <24 hours prior.
5.Measurements to be performed at time of coronary angiography
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
• Pregnant and breastfeeding women, due to the radiation exposure inherent to this study
• Non-cardiac cause of shock (e.g. pulmonary embolism, pneumothorax, cardiac tamponade, etc.)
• Active bleeding
• Prior coronary artery bypass grafting
• Mechanical complication of surgery
• Known left ventricular thrombus
• Mechanical aortic valve
• 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, cerebral ischaemia or current dipyridamole medication use.
• Considered prohibitively hemodynamically unstable (e.g. Noradrenaline dose>50mcg/min)
• Prolonged cardiac arrest (in or out-of-hospital) > 20 minutes prior to return of spontaneous circulation
• Death is considered imminent

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Continuous variables will be presented as medians and interquartile ranges or mean and standard deviation (as appropriate). Categorical variables are presented as frequencies and percentages. All tests will be assessed at the 5% significance level. Differences in proportions were assessed using the Chi square test, Fisher Exact or McNemar test for paired comparisons.


The differences between VA-ECMO, Impella and inotrope group measurements will be compared using an ANOVA test for normally distributed data and Kruskal-Wallis testing for non-normally distributed data. Comparison within MCS groups will assess the differences between haemodynamic variables from the measurements obtained on maximum and minimum support using paired t testing for normally distributed data and Wilcoxon signed-rank testing for non-normally distributed data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/10/2021
Actual
Date of last participant enrolment
Anticipated
3/07/2023
Actual
Date of last data collection
Anticipated
24/07/2023
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20003 0
The Alfred - Melbourne
Recruitment hospital [2] 20004 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 34712 0
3004 - Melbourne
Recruitment postcode(s) [2] 34713 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 309194 0
Hospital
Name [1] 309194 0
Alfred Health Department of Cardiology
Country [1] 309194 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Road. Prahran. Vic. 3004
Country
Australia
Secondary sponsor category [1] 310154 0
None
Name [1] 310154 0
NA
Address [1] 310154 0
NA
Country [1] 310154 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309048 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 309048 0
Ethics committee country [1] 309048 0
Australia
Date submitted for ethics approval [1] 309048 0
01/03/2021
Approval date [1] 309048 0
10/09/2021
Ethics approval number [1] 309048 0
HREC/68158/Alfred-2021

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

Contacts
Principal investigator
Name 112782 0
A/Prof William Chan
Address 112782 0
The Alfred Hospital
55 Commercial Road, Prahran.
Vic. 3004.
Country 112782 0
Australia
Phone 112782 0
+613 90767312
Fax 112782 0
Email 112782 0
[email protected]
Contact person for public queries
Name 112783 0
Jason Bloom
Address 112783 0
The Alfred Hospital
55 Commercial Road, Prahran.
Vic. 3004.
Country 112783 0
Australia
Phone 112783 0
+613 90767312
Fax 112783 0
Email 112783 0
[email protected]
Contact person for scientific queries
Name 112784 0
Jason Bloom
Address 112784 0
The Alfred Hospital
55 Commercial Road, Prahran.
Vic. 3004.
Country 112784 0
Australia
Phone 112784 0
+613 90767312
Fax 112784 0
Email 112784 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?

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.