None listed
Conditions
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.
Interventions
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.
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.
Sponsors
Dr Rohit Barthwal
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
receiving elective coronary stenting/angioplasty
Exclusion criteria
Pregnancy Actively treated haematopoietic cancers Unable to provide their own consent for the stenting procedure
Outcome results
None listed