Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001562369
Ethics application status
Approved
Date submitted
5/11/2017
Date registered
17/11/2017
Date last updated
22/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pulmonary artery pulsatility during and after exacerbations of chronic obstructive pulmonary disease (COPD): a prospective observational cohort study
Scientific title
Pulmonary artery pulsatility during and after exacerbations of COPD: a prospective observational cohort study
Secondary ID [1] 293281 0
None
Universal Trial Number (UTN)
U1111-1204-6875
Trial acronym
PAPA COPD
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
COPD - chronic obstructive pulmonary disease 305356 0
Condition category
Condition code
Respiratory 304638 304638 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Single centre prospective observational longitudinal cohort study with 12 months follow up. Hospitalised patients with acute exacerbations of COPD will be recruited, and undergo CT at baseline and after 12 months. This CT will measure a parameter called pulmonary artery pulsatility (a dynamic CT measurement of pulmonary artery diameter).
Intervention code [1] 299541 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303871 0
Mortality
Timepoint [1] 303871 0
12 months
Secondary outcome [1] 340323 0
Hospitalisations
Timepoint [1] 340323 0
12 months

Eligibility
Key inclusion criteria
Acute exacerbations of COPD admitted to Monash Medical Centre, Clayton, Victoria, Australia
Sinus rhythm
Minimum age
35 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
WHO group I or III pulmonary hypertension
Unable to undergo CT (eg allergy to intravenous iodinated contrast, egfr <60, weight >204kg due to scanner limitations, pregnant)
Unable to consent or participate in follow up

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
We aim to recruit 152 patients.

The primary analysis will be a Cox proportional hazards regression. In our preliminary cohort (n=58) HR is about 14.0 (95% 1.6-127) and the prevalence is about 30%. Using Schoenfeld's method (Biometrics 1983) for sample size calculations and inputs alpha 0.05, power 0.8, PH prevalence 30%, a conservative estimate for HR of 2.5 with 10% dropout the number required is 152.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/02/2018
Actual
Date of last participant enrolment
Anticipated
28/02/2021
Actual
Date of last data collection
Anticipated
28/02/2022
Actual
Sample size
Target
152
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9345 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 18019 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 297907 0
Hospital
Name [1] 297907 0
Monash Health
Country [1] 297907 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
Monash Health, 246 Clayton Rd, Clayton, 3168, Victoria
Country
Australia
Secondary sponsor category [1] 296970 0
None
Name [1] 296970 0
Address [1] 296970 0
Country [1] 296970 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298957 0
Monash HREC A
Ethics committee address [1] 298957 0
Monash Health, 246 Clayton Rd, Clayton, 3168, Victoria
Ethics committee country [1] 298957 0
Australia
Date submitted for ethics approval [1] 298957 0
15/11/2017
Approval date [1] 298957 0
21/12/2017
Ethics approval number [1] 298957 0

Summary
Brief summary
Many patients with Chronic Obstructive Pulmonary Disease (COPD) also have elevated lung blood pressures, or pulmonary hypertension (PH). Having both conditions increases the risk of death. It is difficult to diagnose PH in COPD. We will be using a new Computed Tomography (X-ray imaging) technique to investigate a marker of PH called ‘pulmonary artery pulsatility’. If PH can be diagnosed easily and accurately new treatments can be devised and researched potentially improving outcomes in COPD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78786 0
Dr Paul Leong
Address 78786 0
Monash Lung & Sleep
Monash Health
246 Clayton Rd, Clayton, 3168, Victoria
Country 78786 0
Australia
Phone 78786 0
+61 03 9594 2900
Fax 78786 0
Email 78786 0
[email protected]
Contact person for public queries
Name 78787 0
Dr Paul Leong
Address 78787 0
Monash Lung & Sleep
Monash Health
246 Clayton Rd, Clayton, 3168, Victoria
Country 78787 0
Australia
Phone 78787 0
+61 03 9594 2900
Fax 78787 0
Email 78787 0
[email protected]
Contact person for scientific queries
Name 78788 0
Dr Paul Leong
Address 78788 0
Monash Lung & Sleep
Monash Health
246 Clayton Rd, Clayton, 3168, Victoria
Country 78788 0
Australia
Phone 78788 0
+61 03 9594 2900
Fax 78788 0
Email 78788 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
EmbaseTreatable cardiac disease in hospitalised copd exacerbations.2021https://dx.doi.org/10.1183/23120541.00756-2020
N.B. These documents automatically identified may not have been verified by the study sponsor.