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Trial registered on ANZCTR


Registration number
ACTRN12624001248550p
Ethics application status
Submitted, not yet approved
Date submitted
16/09/2024
Date registered
11/10/2024
Date last updated
11/10/2024
Date data sharing statement initially provided
11/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment for coronary artery vasospasm as a cause for patients with unexplained cardiac arrest.
Scientific title
Provocative coronary testing in patients with unexplained cardiac arrest (PROCORA)
Secondary ID [1] 312975 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac arrest 335155 0
Coronary artery vasospasm 335156 0
Condition category
Condition code
Cardiovascular 331649 331649 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
Patients with unexplained cardiac arrest will undergo an invasive functional angiography 4-6 weeks following their cardiac arrest, with administration of intracoronary acetylcholine boluses to assess for coronary artery vasospasm. The left coronary artery will be assessed first, by injecting escalating doses of acetylcholine from 50mcg, 100mcg, 150mcg and 200mcg. If a diagnosis of coronary vasospasm is achieved prior to reaching the maximum 200mcg dose then no further boluses will be administered. If no diagnosis is achieved following assessment of the left coronary artery then the right coronary artery will be assessed with escalating boluses of acetylcholine from 20mcg, 40mcg, 60mcg and 80mcg. If a diagnosis of coronary vasospasm is achieved prior to reaching the maximum 80mcg dose then no further boluses will be administered. This will be performed by the cardiologists participating as study investigators in this study. The procedure will take approximately 1 hour to perform. Results from this investigation and adherence will be obtained from hospital medical records. Patients not wishing to participate in this study may also be recommended to undergo invasive functional angiography however this would be up to the discretion of their treating clinician and is not part of standard work up.
Intervention code [1] 329513 0
Diagnosis / Prognosis
Comparator / control treatment
A comparator group will be used in this study, and will consist of patients with explained cardiac arrest due to obstructive coronary atherosclerotic disease. These patients will be selected from patients who will require staged percutaneous coronary intervention, 4-6 weeks following their initial cardiac arrest. They will undergo invasive functional coronary angiography as an additional component to their percutaneous coronary intervention.
Control group
Active

Outcomes
Primary outcome [1] 339380 0
Percentage of patients with a diagnosis of coronary artery vasospasm.
Timepoint [1] 339380 0
Once off assessment 4-6 weeks following cardiac arrest.
Secondary outcome [1] 440030 0
Nil
Timepoint [1] 440030 0
Nil

Eligibility
Key inclusion criteria
Patients aged 18 years with unexplained cardiac arrest.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with an identifiable or clinically suspected cause for cardiac arrest according to clinicians caring for the patient inclusive of but not limited to:
- Acute coronary syndrome due to plaque rupture or severe disease
- Suspected cardiac arrhythmias from LQTS, Brugada or other arrhythmogenic cause
- Non-cardiac causes e.g. acute renal failure, pulmonary emboli, sepsis
- Acute myocardial dysfunction or inflammation e.g. myocarditis, infection (COVID)

Contraindications to receiving acetylcholine.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
31/01/2027
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 317415 0
Self funded/Unfunded
Name [1] 317415 0
Country [1] 317415 0
Primary sponsor type
Government body
Name
Alfred Health
Address
Country
Australia
Secondary sponsor category [1] 319697 0
None
Name [1] 319697 0
Address [1] 319697 0
Country [1] 319697 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316135 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316135 0
https://www.alfredhealth.org.au/research/ethics-research-governance
Ethics committee country [1] 316135 0
Australia
Date submitted for ethics approval [1] 316135 0
02/10/2024
Approval date [1] 316135 0
Ethics approval number [1] 316135 0

Summary
Brief summary
A national, multi-centre observational study is proposed to evaluate the prevalence of coronary artery vasospasm in patients with unexplained cardiac arrest. Patients over the age of 18 years who have suffered an unexplained cardiac arrest (n=60) will undergo invasive functional angiography with acetylcholine challenge to assess for coronary artery vasospasm as a potential cause for their cardiac arrest. A small control group of patients with explained cardiac arrest (n=10) will also undergo functional coronary angiography as a comparator. The primary end point is the percentage of patients with a diagnosis of coronary artery vasospasm as defined by the Coronary Vasomotor Disorders International Study Group (COVADIS) criteria. The secondary end point is the association of risk factors leading to a diagnosis of coronary artery vasospasm. We expect this study will show a significant percentage of patients with a diagnosis of coronary artery vasospasm as a potential cause for their cardiac arrest, which will allow for targeted treatment in the prevention of further cardiac arrest, leading to improved patient outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136898 0
Prof William Chan
Address 136898 0
The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria, 3004
Country 136898 0
Australia
Phone 136898 0
+61 435612868
Fax 136898 0
Email 136898 0
[email protected]
Contact person for public queries
Name 136899 0
Brendan Backhouse
Address 136899 0
The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria, 3004
Country 136899 0
Australia
Phone 136899 0
+61 421189381
Fax 136899 0
Email 136899 0
[email protected]
Contact person for scientific queries
Name 136900 0
Brendan Backhouse
Address 136900 0
The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria, 3004
Country 136900 0
Australia
Phone 136900 0
+61 421189381
Fax 136900 0
Email 136900 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.