Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001483347
Ethics application status
Approved
Date submitted
12/10/2017
Date registered
19/10/2017
Date last updated
28/05/2021
Date data sharing statement initially provided
28/05/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Coronary and Peripheral Haemodynamic Studies of Angina with Normal Coronary Arteries
Scientific title
Clinical and coronary haemodynamic determinants of recurrent chest pain in patients without obstructive coronary artery disease
Secondary ID [1] 290993 0
Nil Known
Universal Trial Number (UTN)
U1111-1203-6620
Trial acronym
COMBO STUDY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Angina 305073 0
Condition category
Condition code
Cardiovascular 304391 304391 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 angina and no obstructive coronary disease on angiogram will undergo comprehensive invasive coronary haemodynamic studies at the time of diagnostic coronary angiogram to evaluate possible coronary disorder leading to patient's symptoms and then relating the testing results to outcome, which in this study is ongoing chest pain at one and 12 months follow up.
Haemodynaamic 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 angiogram procedure.
Intervention code [1] 299362 0
Diagnosis / Prognosis
Comparator / control treatment
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303632 0
recurrent chest pain which is defined as one or more episodes of pain per week determined from the Seattle Angina Questionnaire.
Timepoint [1] 303632 0
one and 12 month by telephonic call
Secondary outcome [1] 339714 0
admission to hospital with chest pain
Timepoint [1] 339714 0
12 months by telephonic call and will also review medical records
Secondary outcome [2] 339746 0
Myocardial infraction
Timepoint [2] 339746 0
12 months by telephonic call and will also review medical records
Secondary outcome [3] 339747 0
stroke
Timepoint [3] 339747 0
12 months by telephonic call and will also review medical records
Secondary outcome [4] 339748 0
Death
Timepoint [4] 339748 0
12 months by telephonic call and will also review medical records
Secondary outcome [5] 339836 0
MACE
Timepoint [5] 339836 0
12 months by telephonic call and review of medical records

Eligibility
Key inclusion criteria
Patients with (1) clinical diagnosis of angina, (2) persistent angina and (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%), or (4) alternative coronary explanations for the chest pain - obstructive CAD (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, or (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
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
57
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 9183 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 17819 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 295417 0
Hospital
Name [1] 295417 0
Cardiology Departement The Queen Elizabeth Hospita, Internal research funds
Country [1] 295417 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Department of Medicine
Graduate centre
Level 2, Schulz Building,
The University of Adelaide SA 5005
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 294235 0
None
Name [1] 294235 0
Address [1] 294235 0
Country [1] 294235 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296749 0
TQEH/LMH/MH Human Research Ethics Committee and Central Adelaide CALHN Research Governance
Ethics committee address [1] 296749 0
Ethics committee country [1] 296749 0
Australia
Date submitted for ethics approval [1] 296749 0
Approval date [1] 296749 0
14/08/2013
Ethics approval number [1] 296749 0
HREC/12/TQEHLMH/155

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

Contacts
Principal investigator
Name 71946 0
Prof John Beltrame
Address 71946 0
Discipline of Medicine, The University of Adelaide, The Queen Elizabeth Hospital
28- Woodville Rd, Woodville South, South Australia 5011,
Country 71946 0
Australia
Phone 71946 0
+61882226740
Fax 71946 0
+61882227201
Email 71946 0
[email protected]
Contact person for public queries
Name 71947 0
Sivabaskari Pasupathy
Address 71947 0
Discipline of Medicine, The University of Adelaide, The Queen Elizabeth Hospital
28- Woodville Rd, Woodville South, South Australia 5011,
Country 71947 0
Australia
Phone 71947 0
+61882226740
Fax 71947 0
+61882227201
Email 71947 0
[email protected]
Contact person for scientific queries
Name 71948 0
Sivabaskari Pasupathy
Address 71948 0
Discipline of Medicine, The University of Adelaide, The Queen Elizabeth Hospital
28- Woodville Rd, Woodville South, South Australia 5011,
Country 71948 0
Australia
Phone 71948 0
+61882226740
Fax 71948 0
+61882227201
Email 71948 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
Data will be provided in publication of study outcome. This will exclude raw and individual participant data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11813Study protocol  [email protected]
11814Ethical approval  [email protected]
11815Informed consent form  [email protected]



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.