Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001312235
Ethics application status
Approved
Date submitted
4/11/2017
Date registered
6/08/2018
Date last updated
22/10/2021
Date data sharing statement initially provided
22/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Laser therapy prior to treatment by stenting for blocked heart arteries
Scientific title
Photobiomodulation Prior to Elective Coronary Stenting for prevention of cardiac muscle damage as measured by hs troponin and representation to hospital.
Secondary ID [1] 293282 0
None
Universal Trial Number (UTN)
U1111-1204-6967
Trial acronym
PPECS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 305357 0
Condition category
Condition code
Cardiovascular 304640 304640 0 0
Coronary heart disease
Surgery 304699 304699 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prior to presentation at the Launceston General Hospital for elective percutaneous coronary stenting patients will be offered the opportunity to participate in the trial. If they consent they will be randomised to receive either active cutaneous laser therapy (photobiomodulation) or a placebo treatment 1-3 hours prior to their stenting procedure. The active group will receive laser applied using an Irradia Mid-Laser 808. The wavelength of the laser is 808nm with a maximum power output of 500mW. 6J (500mW x 6 seconds) of energy will be applied to 5 points over the heart, 30J (300mW x 50 seconds) to the right radial artery, 2J (150mW x 7 seconds) to the supraclavicular lymph nodes and 4J (300mW x 7 seconds) to 3 points on the sternum.
Participants with tattoos over the site of application will have their sites moved to the nearest relevant location.
Intervention code [1] 299537 0
Treatment: Devices
Comparator / control treatment
Patients in the placebo arm will be treated with a machine of identical appearance but with no active laser component for the same length of time
Control group
Placebo

Outcomes
Primary outcome [1] 303867 0
serum high sensitivity troponin
Timepoint [1] 303867 0
24 hours after elective percutaneous coronary angioplasty
Secondary outcome [1] 340749 0
Hospital readmission
Timepoint [1] 340749 0
At 1 month and 12 months after elective percutaneous coronary angioplasty
Secondary outcome [2] 340983 0
Cardiovascular death
Timepoint [2] 340983 0
At 1 month and 12 months
Secondary outcome [3] 340985 0
Local side effects at laser sites
Timepoint [3] 340985 0
1 month and 12 months
Secondary outcome [4] 349814 0
The change in the proportion of patients with hs (high sensitivity) troponin levels of 25 or more, 30 or more and 80 or more between the prior-to-procedure and 24-hours-after measures
Timepoint [4] 349814 0
24 hours post procedure
Secondary outcome [5] 349815 0
The distribution of change in the proportion of patients with hs (high sensitivity) troponin levels of 40 or more between the prior-to-procedure and 24-hours-after measures; measured as median, interquartile range, plus 90th and 95th percentiles; with the difference in distribution tested by mixed effects ordered logistic regression
Timepoint [5] 349815 0
24 hours post procedure

Eligibility
Key inclusion criteria
receiving elective coronary stenting/angioplasty
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Actively treated haematopoietic cancers
Unable to provide their own consent for the stenting procedure

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
double blinded, centrally randomised by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
stratified block randomised.
Stratification on the basis of the SYNTAX score
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Interim analysis will be performed after 260 participants are recruited to check power/sample size calculation
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome of change in hs (high sensitivity) troponin levels from pre- to 24-hours post-procedure levels difference between intervention and control groups will be estimated by mixed effect general linear modelling, adjusting for potential confounding variables, and treating time from procedure to post-procedure blood sampling as a random effect. The comparable secondary outcomes will be estimated in the same way.
The difference between treatment groups in the distribution of change in hs (high sensitivity) troponin levels between the pre-procedure and 24-hours-after measures will be described as median, interquartile range, plus 90th and 95th percentiles (estimated by sequential quantile regression), with the difference in distributions between groups tested by mixed effects ordered logistic regression (odds ratios, 95% confidence intervals, P-values).
The difference between groups in time-to-events for adverse events (hospital readmission and mortality) will be compared using Cox proportional hazards regression, where any significant numbers of events have occurred (adjusted for age and gender). Where numbers are insufficient for valid effect size estimation, occurrence of events will be compared using Fisher’s exact test.
An interim analysis after the completion of treatment of the first 260 patients will be conducted only for the primary outcome. The treatment allocation code will not be broken during the interim analysis. The only result from this interim analysis will be the detection of the presence of a group difference at an alpha level of 0.05. If detected, the researchers will be recommended to proceed immediately to final analysis. If no such difference is found, the researchers will be recommended to continue to recruitment of 520 patients.
All analysis will be performed on an intention-to-treat basis, when testing the prior hypotheses, but per-protocol analyses may be performed for exploratory analyses if these are relevant based on rates of failure to complete protocol.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/09/2018
Actual
30/09/2018
Date of last participant enrolment
Anticipated
1/06/2022
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
520
Accrual to date
248
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 9340 0
Launceston General Hospital - Launceston
Recruitment hospital [2] 20829 0
Calvary Health Care Tasmania - Launceston campus - Launceston
Recruitment postcode(s) [1] 18015 0
7250 - Launceston
Recruitment postcode(s) [2] 35655 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 297908 0
Charities/Societies/Foundations
Name [1] 297908 0
Clifford Craig Medical Medical Research Trust
Country [1] 297908 0
Australia
Primary sponsor type
Individual
Name
Dr Rohit Barthwal
Address
Department of Cardiology
Launceston General Hospital
Charles St
Launceston
Tasmania, 7250
Australia
Country
Australia
Secondary sponsor category [1] 296965 0
Individual
Name [1] 296965 0
Dr Michael Fox
Address [1] 296965 0
Department of Cardiology
Launceston General Hospital
Charles St
Launceston
Tasmania, 7250
Australia
Country [1] 296965 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298958 0
Tasmania Health and Medical Human Research Ethics Committee
Ethics committee address [1] 298958 0
Office of Research Services
University of Tasmania
Private Bag 1, 301 Sandy Bay Rd
Hobart TAS 7000
Ethics committee country [1] 298958 0
Australia
Date submitted for ethics approval [1] 298958 0
18/12/2017
Approval date [1] 298958 0
03/08/2018
Ethics approval number [1] 298958 0
H0017007

Summary
Brief summary
Coronary artery disease affects an estimated 1.2 million Australian and over 47,000 stents are inserted in Australia each year.

This is a double-blind, randomized, placebo-controlled clinical trial intended to evaluate if photobiomodulation (low level laser applied to the skin) reduces the damage to heart muscle during elective coronary artery stenting

Participants will receive either an active laser treatment of an 808nm laser or a placebo laser for a similar length of time

Participants will be block randomised and stratified on the basis of lesion description and SYNTAX score Into low and high risk groups.

Participants will be excluded if they are under the age of 18 years, pregnant or receiving treatment for haematopoietic malignancy

The primary outcome measure is the change in troponin levels between the prior and the 24 hour measures.

After discussion with the cardiology working group it was decided that a 30% reduction in troponin rise in this intervention would be considered clinically significant. It was estimated that a sample size of 520 would have sufficient power. An interim analysis will be performed after 260 participants to check if sample size is sufficient

The Student’s dependent samples t-test will be used to compare mean values of continuous variables approximating a normal distribution. For non-normally distributed variables ordinal logistical regression will be used.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78790 0
Dr Rohit Barthwal
Address 78790 0
Cardiology Department
Launceston General Hospital
Launceston
Tasmania, 7250
Country 78790 0
Australia
Phone 78790 0
+ 61 3 6777 6777
Fax 78790 0
Email 78790 0
[email protected]
Contact person for public queries
Name 78791 0
Dr Michael Fox
Address 78791 0
Newstead Medical
165 Elphin Road
Newstead
Tasmania, 7250
Country 78791 0
Australia
Phone 78791 0
+ 61 3 6331 1088
Fax 78791 0
+ 61 3 6334 2105
Email 78791 0
[email protected]
Contact person for scientific queries
Name 78792 0
Dr Michael Fox
Address 78792 0
Newstead Medical
165 Elphin Road
Newstead
Tasmania, 7250
Country 78792 0
Australia
Phone 78792 0
+ 61 3 6331 1088
Fax 78792 0
+ 61 3 6334 2105
Email 78792 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data will be available in a de-identified format
When will data be available (start and end dates)?
at current recruitment rates an interim analysis will be conducted in December 2021. A final end date will then be calculated
Available to whom?
Any suitable body that requests it
Available for what types of analyses?
Statistical analyses, t-test for primary outcome measures
How or where can data be obtained?
Contact Clifford Craig Medical Research Trust on [email protected]


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.