Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000801011
Ethics application status
Approved
Date submitted
20/09/2010
Date registered
27/09/2010
Date last updated
18/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Health Status in Patients with Non-Obstructive Coronary Artery Disease
Scientific title
Health Status at 12 months Following Coronary Angiography in Patients with Obstructive and Non-Obstructive Coronary Artery Disease
Secondary ID [1] 252724 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-obstructive coronary artery disease 258218 0
Obstructive coronary artery disease 258219 0
Condition category
Condition code
Cardiovascular 258396 258396 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The conditions to be observed are non-obstructive coronary artery disease and obstructive coronary artery disease for a period of 12 months.
This will involve an observational and prospective, longitudinal follow-up (12 months) of health status outcomes in patients presenting for coronary angiography for the investigation of chest pain, who show either obstructive or non-obstructive coronary artery disease on angiography. Patients who undergo coronary angiography at either the Queen Elizabeth Hospital or Lyell McEwin Hospital, in Adelaide, Australia will be approached for consenting prior angiography. Health status outcomes to be investigated include health-related quality of life, and clinical characteristics at angiography and then at 1, 6 and 12 months following angiography.
Intervention code [1] 257235 0
Not applicable
Intervention code [2] 293644 0
Not applicable
Comparator / control treatment
There is no comparator being studied. This research is an observational study evaluating health status in patients with obstructive or non-obstructive coronary artery disease.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259239 0
The Short Form-36 Physical Summary Score. The Short Form-36 is a self-administered generic health status instrument quantitating overall physical health status.
Timepoint [1] 259239 0
12 months following coronary angiography (time of recruitment)
Secondary outcome [1] 265647 0
The Seattle Angina Questionnaire domain scores. The Seattle Angina Questionnaire is a self-administered disease-specific health status instruments evaluating the impact of coronary heart disease on a patient's life.
Timepoint [1] 265647 0
12 months following coronary angiography (time of recruitment)

Eligibility
Key inclusion criteria
1) Coronary angiography for the evaluation of chest pain.
2) Ability to comprehend and complete questionnaires in English
3) Obstructive or non-obstructive coronary artery disease on angiography
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Cardiomyopathy
2) Aortic or mitral valve disease
3) Pericarditis
4) Pulmonary hypertension or pulmonary embolism

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2003
Actual
1/04/2003
Date of last participant enrolment
Anticipated
Actual
29/05/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
Final
1146
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257679 0
Self funded/Unfunded
Name [1] 257679 0
Country [1] 257679 0
Primary sponsor type
University
Name
The University of Adelaide
Address
North Terrace
Adelaide South Australia 5005
Country
Australia
Secondary sponsor category [1] 256896 0
None
Name [1] 256896 0
Address [1] 256896 0
Country [1] 256896 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259711 0
Ethics of Human Research Committee - The Queen Elizabeth Hospital
Ethics committee address [1] 259711 0
The Queen Elizabeth Hospital
28 Woodville Road
WOODVILLE SOUTH SA 5011
Ethics committee country [1] 259711 0
Australia
Date submitted for ethics approval [1] 259711 0
Approval date [1] 259711 0
09/03/2003
Ethics approval number [1] 259711 0

Summary
Brief summary
The study aims to evaluate the natural history and health outcomes of patients with chest pain who have non-obstructive coronary artery disease. These patients traditionally have been though to have a benign prognosis and frequently have their symptoms trivialized. Despite this, persistence of chest pain symptoms is common and limited therapeutic strategies cause significant morbidity in these patients. This is in contrast patients who have obstructive coronary artery disease, who although are at increased risk of mortality, receive attention and experience symptom relief with medication and surgical interventions. There is limited longitudinal data available assessing and evaluating patients with non-obstructive coronary artery disease, especially utilizing valid and reproducible health status assessments and also comparing them to other patients who experience similar symptoms but have a clear etiology for their pain. This is important since the incidence of non-obstructive coronary artery disease may be as high as 30% of angiograms performed. Thus this study aims to evaluate the health status of patients who undergo coronary angiography for chest pain who show non-obstructive coronary artery disease and compare these to patients who undergo the procedure and show obstructive coronary artery disease, for a period of 12 months following index angiography.
Trial website
This trial does not utilize a website.
Trial related presentations / publications
“Quality of life with Percutaneous Coronary Intervention (PCI) versus medical therapy in stable coronary disease,” authored by John F. Beltrame, Rosanna Tavella and Natalie Cutri and published in the New England Journal of Medicine, Volume 359, Issue 21, Pages 2289-90, 2008
Public notes

Contacts
Principal investigator
Name 31665 0
Prof John Beltrame
Address 31665 0
The Queen Elizabeth Hospital
Discipline of Medicine
28 Woodville Rd
Woodville South, SA. 5011. Australia
Country 31665 0
Australia
Phone 31665 0
+61 8 8222 6740
Fax 31665 0
Email 31665 0
[email protected]
Contact person for public queries
Name 14912 0
Dr Rosanna Tavella
Address 14912 0
Basil Hetzel Institute
The Queen Elizabeth Hospital
37a Woodville Rd
WOODVILLE SOUTH SA 5011
Country 14912 0
Australia
Phone 14912 0
+61 8 81334011
Fax 14912 0
+61 8 82226033
Email 14912 0
[email protected]
Contact person for scientific queries
Name 5840 0
Prof Professor John F. Beltrame
Address 5840 0
The Queen Elizabeth Hospital
Discipline of Medicine
University of Adelaide
28 Woodville Rd
WOODVILLE SOUTH SA 5011
Country 5840 0
Australia
Phone 5840 0
+61 8222 6740
Fax 5840 0
Email 5840 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseNatural history of patients with insignificant coronary artery disease.2016https://dx.doi.org/10.1093/ehjqcco/qcv034
N.B. These documents automatically identified may not have been verified by the study sponsor.