Trial Review

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With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000149268
Ethics application status
Approved
Date submitted
21/01/2018
Date registered
31/01/2018
Date last updated
28/03/2022
Date data sharing statement initially provided
1/10/2019
Date results provided
28/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Coronary and Peripheral Haemodynamic Studies of Angina with No Obstructive Coronary Artery Disease.
Scientific title
Clinical and coronary haemodynamic determinants of recurrent chest pain in patients with no obstructive coronary artery disease.
Secondary ID [1] 293492 0
Nil Known
Universal Trial Number (UTN)
U1111-1206-8080
Trial acronym
NoCAD1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Angina 305940 0
Condition category
Condition code
Cardiovascular 305133 305133 0 0
Coronary heart disease
Cardiovascular 305460 305460 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with angina and no obstructive coronary artery disease on invasive diagnostic coronary angiography will undergo comprehensive invasive coronary haemodynamic studies at the time of procedure to evaluate possible coronary vasomotor disorder leading to patient's symptoms and then relating the testing results to outcome, which in this study is ongoing chest pain at 1, 6 and 12 months follow up.
Haemodynamic studies will include the assessment of resting angiographic contrast flow, coronary microvascular hyperaemic function, coronary endothelial function and provocative coronary spasm testing. This comprehensive testing will add 30-45 minutes to the diagnostic coronary angiography procedure.
Intervention code [1] 299914 0
Diagnosis / Prognosis
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304287 0
Recurrent angina which is defined as one or more episodes of pain per week determined from the Seattle Angina Questionnaire.
Timepoint [1] 304287 0
1, 6 and 12 months (primary timepoint) after coronary haemodynamics study,
Secondary outcome [1] 341510 0
Hospital admission with recurrent angina. The information will be obtained from linkage to medical records.
Timepoint [1] 341510 0
Over 12 months post coronary haemodynamics study.
Secondary outcome [2] 341511 0
Major adverse cardiovascular events (MACE): Cardiovascular death, myocardial infarction and stroke. (Composite endpoint) The information will be obtained from linkage to medical records.
Timepoint [2] 341511 0
Over 12 months post coronary haemodynamics study.

Eligibility
Key inclusion criteria
1. Clinical diagnosis of angina
2. Persistent angina
3. Coronary angiography demonstrating normal or no obstructive coronary disease (<50% diameter stenosis)
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Admission for an acute coronary syndrome within the preceding month
2. Prior coronary artery bypass grafting
3. Contra-indications to coronary haemodynamic assessment - patients with permanent pacemaker or defibrillator, severe renal or hepatic insufficiency, severe asthma, left ventricular systolic dysfunction (ejection fraction <50%)
4. Alternative coronary explanations for the chest pain - obstructive coronary artery disease (flow limiting coronary stenosis i.e. derived fractional flow reserve (FFR) <0.80), spontaneous coronary spasm (but not catheter related spasm), spontaneous coronary artery dissection
5. Other cardiovascular disorders - pulmonary hypertension, pulmonary embolism, hypertrophic cardiomyopathy, or valvular heart disease.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size is calculated on the principle of a minimum of 10 events per each predictor variable. Results will be expressed as mean +/- SD for normally distributed data and median (25th–75th percentiles) for data that were not normally distributed. Fisher-Exact test will be used to assess for differences between categorical variables. Student-t tests or Mann Whitney rank-sum tests will be used to assess for differences between groups for continuous variables. Logistic regression model will be fitted to identify the determinants of recurrent chest pain. Variables that are significantly associated with chest pain at p<0.20 in univariate analysis will be selected for inclusion in multivariate logistic regression. The final independent predictors were identified using backward elimination. P-value of = 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2018
Actual
1/02/2018
Date of last participant enrolment
Anticipated
Actual
5/11/2020
Date of last data collection
Anticipated
Actual
29/01/2021
Sample size
Target
100
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 9619 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 18374 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 298110 0
Hospital
Name [1] 298110 0
Cardiology Unit, Lyell McEwin Hospital, Internal Research Fund
Country [1] 298110 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Country
Australia
Secondary sponsor category [1] 297386 0
None
Name [1] 297386 0
Country [1] 297386 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299129 0
TQEH/LMH/MH Human Research Ethics Committee and Northern Adelaide Local Health Network, NALHN Research Governance
Ethics committee address [1] 299129 0
Ethics committee country [1] 299129 0
Australia
Date submitted for ethics approval [1] 299129 0
14/08/2017
Approval date [1] 299129 0
07/11/2017
Ethics approval number [1] 299129 0
HREC/17/TQEH/156

Summary
Brief summary
Trial website
Public notes
Attachments [1] 2300 2300 0 0
/AnzctrAttachments/374085-Approval%20Letter%20-%20Arstall%20NOCAD%20Project%20A%20-%20Q20170706.pdf (Ethics approval)
Attachments [2] 2301 2301 0 0
/AnzctrAttachments/374085-SSA%2017%20NALHN%2098%20%20Final%20Authorisation.pdf (Other)

Contacts
Principal investigator
Name 79398 0
A/Prof Margaret Arstall
Address 79398 0
Cardiology Unit, Lyell McEwin Hospital, Northern Adelaide Local Health Network (NALHN) Haydown Rd, Elizabeth Vale SA 5112
Country 79398 0
Australia
Phone 79398 0
+61 8 81829439
Fax 79398 0
+61 8 82820706
Email 79398 0
margaret.arstall@sa.gov.au
Contact person for public queries
Name 79399 0
Sharmalar Rajendran
Address 79399 0
Cardiology Unit, Lyell McEwin Hospital, Northern Adelaide Local Health Network (NALHN) Haydown Rd, Elizabeth Vale SA 5112
Country 79399 0
Australia
Phone 79399 0
+61 8 81829439
Fax 79399 0
+61 8 82820706
Email 79399 0
sharmalar.rajendran@sa.gov.au
Contact person for scientific queries
Name 79400 0
John Beltrame
Address 79400 0
Discipline of Medicine, The University of Adelaide, The Queen Elizabeth Hospital 28, Woodville Rd, Woodville South, South Australia 5011,
Country 79400 0
Australia
Phone 79400 0
+61 8 82226740
Fax 79400 0
+61 8 82227201
Email 79400 0
john.beltrame@adelaide.edu.au

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers outside the primary investigators.

Conditions for requesting access:
• -

What individual participant data might be shared?
• A limited, de-identified set of data available for researchers outside the primary investigators and will be specified in the data sharing plan.

What types of analyses could be done with individual participant data?
• The type of analyses must be specified in the data sharing agreement between the providing agency and the requesting researchers.

When can requests for individual participant data be made (start and end dates)?
From:
No end date determined. Two years after the publication of the primary results of the study. The endpoint of the availability to be specified by the investigators.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Before data are shared, a data-sharing agreement should be established documenting what data are being shared and how the data can be used. The agreement serves two purposes. First, it protects the agency providing the data, ensuring that the data will not be misused. Second, it prevents miscommunication on the part of the provider of the data and the agency receiving the data by making certain that any questions about data use are discussed. The following items should be covered in the data-sharing agreement:

Period of agreement
The intended use of the data
Constraints on the use of the data
Data confidentiality
Data security
Methods of data-sharing


Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1055Informed consent form    Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Association of Obstructive Sleep Apnea in Ischemia with No Obstructive Coronary Artery Disease - A Pilot Study.2023https://dx.doi.org/10.1016/j.cpcardiol.2022.101111
N.B. These documents automatically identified may not have been verified by the study sponsor.