Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000708954
Ethics application status
Approved
Date submitted
8/07/2011
Date registered
8/07/2011
Date last updated
4/09/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multi-centre audit of ACE inhibitor associated angioedema
Scientific title
A retrospective case note audit of symptoms, signs and management of patients attending hospital accident and emergency departments with angioedema who are currently taking an ACE inhibitor
Secondary ID [1] 262139 0
nil
Universal Trial Number (UTN)
Trial acronym
MAAAA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
angioedema 265817 0
Condition category
Condition code
Inflammatory and Immune System 265971 265971 0 0
Allergies

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All patients included in the audit will have been exposed to an ACE inhibitor medication as part of their routine treatment. There will be no additional exposures as part of the conduct of the study. The audit is of patients presenting to hospital emergency departments with angioedema between Jan 2008 and Dec 2010. The occurance of angioedema is the outcome being observed.
Intervention code [1] 264553 0
Not applicable
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266715 0
symptoms - time of onset of angioedema, localisation of angioedema, any evidence of airway impairment.

Angioedema is detected by physical findings on clinical examination. These will be identified in the clinical record and will be found on case note review.
Timepoint [1] 266715 0
at time of presentation to the hospital accident and emergency department
Secondary outcome [1] 276242 0
treatment used - adrenaline, antihistamines, steroids, need for intubation or tracheostomy
Timepoint [1] 276242 0
at time of presentation to hospital

Eligibility
Key inclusion criteria
Angioedema - ICD 9 Code 995.1, or ICD 10 Code T 78.3

must be on an ACE inhibior
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
not taking an ACE inhibitor

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/05/2011
Actual
10/06/2011
Date of last participant enrolment
Anticipated
Actual
12/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 265032 0
Self funded/Unfunded
Name [1] 265032 0
Country [1] 265032 0
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace
Adelaide
South Australia 5051
Country
Australia
Secondary sponsor category [1] 264130 0
University
Name [1] 264130 0
Flinders university
Address [1] 264130 0
University Drive,
Bedford Park
South Australia 5041
Country [1] 264130 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267024 0
Royal Adelaide Hospital Research Ethics committee
Ethics committee address [1] 267024 0
North Terrace
Adelaide 5000
South Australia
Ethics committee country [1] 267024 0
Australia
Date submitted for ethics approval [1] 267024 0
01/04/2011
Approval date [1] 267024 0
11/04/2011
Ethics approval number [1] 267024 0
110415

Summary
Brief summary
This is an audit of patients who present to hospital with angioedema (swelling around the head and neck) associated with the use of a common blood pressure medication, the ACE inhibitors. The purpose is to try to determine how frequently this problem occurs across a range of hospitals, and also, to provide more information to enable an estimation of the proportion of cases where there is serious concern (ie threatened or real airway obstruction or death).
Trial website
Trial related presentations / publications
Multicentre audit of ACE inhibitor associated angioedema

Australian Family Physician 2015;44(8):579-583

Jimit Ghandi, Rachel Jones, David Teubner and Genevieve Gabb
Public notes

Contacts
Principal investigator
Name 32590 0
Dr Genevieve Gabb
Address 32590 0
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 32590 0
Australia
Phone 32590 0
+61400297871
Fax 32590 0
Email 32590 0
[email protected]
Contact person for public queries
Name 15837 0
Dr Genevieve Gabb
Address 15837 0
Royal Adelaide Hospital
North Terrace
Adelaide 5000
South Australia
Country 15837 0
Australia
Phone 15837 0
+61 8 82224613
Fax 15837 0
Email 15837 0
[email protected]
Contact person for scientific queries
Name 6765 0
Dr Genevieve Gabb
Address 6765 0
Royal Adelaide Hospital
North Terrace
Adelaide 5000
South Australia
Country 6765 0
Australia
Phone 6765 0
+61 8 82224613
Fax 6765 0
Email 6765 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.