Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000328976
Ethics application status
Approved
Date submitted
25/03/2011
Date registered
28/03/2011
Date last updated
28/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Nuclear Perfusion Tomography for the Assessment of the Pulmonary Circulation
Scientific title
Nuclear Perfusion Tomography for the Assessment of the Pulmonary Circulation
Secondary ID [1] 259742 0
Nil
Universal Trial Number (UTN)
U1111-1119-9337
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension 261326 0
Condition category
Condition code
Cardiovascular 259471 259471 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will undergo a single photon emission computed tomography lung perfusion scan using technetium labelled macroaggregated albumin. The duration of the scan is approximately 30 minutes. All participant groups (healthy controls, high-risk for pulmonary arterial hypertension, and established pulmonary hypertension) will undergo the same intervention.
Intervention code [1] 264174 0
Early detection / Screening
Comparator / control treatment
Healthy control group are adults age >18 with no history or lung or heart disease; and no risk factors for pulmonary arterial hypertension (ie scleroderma/connective tissue disease, previous thromboembolic disease, relative of idiopathic pulmonary arterial hypertension, HIV infection). The healthy control group will receive the same intervention in the study.
Control group
Active

Outcomes
Primary outcome [1] 262284 0
Distribution of pulmonary perfusion will be analysed via software programme. (ITT Visual Systems, Boulder CO, USA)
Timepoint [1] 262284 0
Baseline
Secondary outcome [1] 273457 0
Normalised lung perfusion volume will be analysed via software programme. (ITT Visual Systems, Boulder CO, USA)
Timepoint [1] 273457 0
Baseline

Eligibility
Key inclusion criteria
1. Control group
- No history of cardiac or respiratory disease
- Normal spirometry
- Normal transthoracic echocardiogram
- Smoking history < 10 years
- No risk factor for pulmonary hypertension

2. High Risk for PAH Group
- History of scleroderma or carrier of BMPR2 mutation
- Normal resting pulmonary artery pressure
- No significant lung disease

2. Pulmonary arterial hypertension (PAH) group
- WHO Classification Group 1 PAH
- Pre-capillary pulmonary arterial hypertension confirmed on Right Heart Catheter: mean pulmonary > 25 mm Hg and wedge pressure <15 mm Hg
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3886 0
2050

Funding & Sponsors
Funding source category [1] 264621 0
University
Name [1] 264621 0
University of Sydney
Country [1] 264621 0
Australia
Primary sponsor type
Individual
Name
David Celermajer
Address
Department of Cardiology
Royal Prince Alfred Hospital
Missenden Road
Camperdown 2050
Country
Australia
Secondary sponsor category [1] 263759 0
Individual
Name [1] 263759 0
Edmund Lau
Address [1] 263759 0
Department of Cardiology
Royal Prince Alfred Hospital
Missenden Road
Camperdown 2050
Country [1] 263759 0
Australia
Other collaborator category [1] 251853 0
Individual
Name [1] 251853 0
Dale Bailey
Address [1] 251853 0
Department of Nuclear Medicine
Royal North Shore Hospital
Pacific Highway
St Leonards
Country [1] 251853 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266625 0
SSWAHS Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 266625 0
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Ethics committee country [1] 266625 0
Australia
Date submitted for ethics approval [1] 266625 0
Approval date [1] 266625 0
18/11/2010
Ethics approval number [1] 266625 0
HREC/10/RPAH/505

Summary
Brief summary
Pulmonary arterial hypertension (PAH) is a devastating condition with a poor prognosis. There are currently no widely available imaging modality to assess lung perfusion, which is decreased in PAH. Single photon emission computed tomography (SPECT) is a nuclear medicine technique which can assess three dimensional lung perfusion. We wish to evaluate the utility of SPECT in the assessment and early detection of PAH.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32316 0
Address 32316 0
Country 32316 0
Phone 32316 0
Fax 32316 0
Email 32316 0
Contact person for public queries
Name 15563 0
Edmund Lau
Address 15563 0
Department of Cardiology
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 15563 0
Australia
Phone 15563 0
+61 2 9515 6794
Fax 15563 0
+61 2 9546 6870
Email 15563 0
[email protected]
Contact person for scientific queries
Name 6491 0
Edmund Lau
Address 6491 0
Department of Cardiology
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 6491 0
Australia
Phone 6491 0
+61 2 9515 6794
Fax 6491 0
+61 2 9546 6870
Email 6491 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
No additional documents have been identified.