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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Non-obstructive coronary artery disease

Obstructive coronary artery disease

Condition category

Condition code

Cardiovascular

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]

Not applicable

Intervention code [2]

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]

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]

12 months following coronary angiography (time of recruitment)

Secondary outcome [1]

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]

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?

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]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

University

Name

The University of Adelaide

Address

North Terrace
Adelaide South Australia 5005

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics of Human Research Committee - The Queen Elizabeth Hospital

Ethics committee address [1]

The Queen Elizabeth Hospital
28 Woodville Road
WOODVILLE SOUTH SA 5011

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

09/03/2003

Ethics approval number [1]

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

Prof John Beltrame

Address

The Queen Elizabeth Hospital
Discipline of Medicine
28 Woodville Rd
Woodville South, SA. 5011. Australia

Country

Australia

Phone

+61 8 8222 6740

Fax

[email protected]

Contact person for public queries

Name

Rosanna Tavella

Address

Basil Hetzel Institute
The Queen Elizabeth Hospital
37a Woodville Rd
WOODVILLE SOUTH SA 5011

Country

Australia

Phone

+61 8 81334011

Fax

+61 8 82226033

[email protected]

Contact person for scientific queries

Name

Professor John F. Beltrame

Address

The Queen Elizabeth Hospital
Discipline of Medicine
University of Adelaide
28 Woodville Rd
WOODVILLE SOUTH SA 5011

Country

Australia

Phone

+61 8222 6740

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Natural history of patients with insignificant coronary artery disease.	2016	https://dx.doi.org/10.1093/ehjqcco/qcv034

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically