Effects of Low Level Laser Therapy in comparison with laser therapy with none therapeutic power on the complications of Coronary Artery Bypass Surgery in patients with coronary artery stenosis
(1) Objectives: Evaluate the efficacy of intravenous and local Laser therapy of on the complications of coronary bypass grafting in patients with coronary artery disease. (2) Design: The study population is patients with stenosis in two or three coronary arteries hospitalized in Shahid Rajaee heart center for coronary bypass grafting. Recruited patients will be divided into two equal groups using block randomization. At least 252 patients will be recruited and the trial will be conducted as single blind, phase three, mono centric trial. (3) Setting and conduct: Intravenous and local laser therapy will be applied for patients who has been randomly selected for intervention groups and laser therapy with none therapeutic power will be applied for control group. Ultimately Intervention and control groups will be compared regarding coronary bypass grafting complications. (4) Participants: Patients with stenosis in their coronary arteries hospitalized for coronary artery bypass grafting without chronic diseases or cancer. (5) Intervention: Intravenous and local laser therapy. (6) Main outcome measures: Pericardial effusion, Fibrillation and Heart Failure.
General information
Acronym
CABG or Coronary Artery Bypass Grafting
Low level Laser Therapy or LLLT
IRCT registration information
IRCT registration number:IRCT2016052926069N4
Registration date:2016-08-25, 1395/06/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-25, 1395/06/04
Registrant information
Name
Fereshteh Ansari
Name of organization / entity
Razi Vaccine and Serum Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 26 3405 0400
Email address
ansarif@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Low Level Laser Therapy in comparison with laser therapy with none therapeutic power on the complications of Coronary Artery Bypass Surgery in patients with coronary artery stenosis
Public title
Effects of Low Level Laser Therapy on the complications of CABG
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with stenosis in two or three coronary arteries (2VD/3VD) candidate for CABG.
Exclusion criteria: renal chronic diseases; Hepatic chronic diseases; Diabetes; Cancer
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
252
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Blocked randomization has been applied for this study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Heart Center of Shahid Rajaee
Street address
Niayesh Highway Intersection, Valiasr Street, Tehran
City
Tehran
Postal code
1996911151
Approval date
2016-02-27, 1394/12/08
Ethics committee reference number
IHC.AC.IR.REC.1394.36
Health conditions studied
1
Description of health condition studied
Coronary artery bypass grafting complications
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Atrial fibrilation
Timepoint
Before surgery, after surgery , daily until one week
Method of measurement
Electrocardiography, Ecocardiography
2
Description
Heart Failure
Timepoint
Before surgery, One week after surgery
Method of measurement
Electrocardiography, Ecocardiography
3
Description
Hypertrophic Scar
Timepoint
3 to 6 months after surgery
Method of measurement
Vancouver Scar Scale Questionnaire
4
Description
Death
Timepoint
3 to 6 months after surgery
Method of measurement
Reviewing patients medical records
5
Description
Needing Repetition of CABG
Timepoint
3 to 6 months after surgery
Method of measurement
Reviewing patients medical records
Secondary outcomes
1
Description
Pericardial effusion
Timepoint
Before surgery, One week after surgery
Method of measurement
Electrocardiography, Ecocardiography
2
Description
Bleeding
Timepoint
48 hours after CABG
Method of measurement
Measuring Suctioned blood
Intervention groups
1
Description
Intervention group: Application of Intravenous and local Low level laser.
Intravenous red laser, 655 nm, 1 mW for 15 minutes via cubital vain and local laser, infrared 780 nm, 200 mW, 6 J/Cm2 on the incision area and pericardium. Both lasers are used immediately after the surgery and every day after surgery for 7 days
Category
Prevention
2
Description
control group: Application of intravenous and local Laser with none therapeutic power.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Cardiovascular, Medical & Research Center
Full name of responsible person
Nooshafarin Kazemikhoo
Street address
Niayesh Highway Intersection, Valiasr Ave, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran university of medical science (Rajaie Cardiovascular Medical and
Full name of responsible person
Dr. Majid Kiavar
Street address
Niayesh Highway Intersection, Valiasr Street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran university of medical science (Rajaie Cardiovascular Medical and
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Skin and Stem Cell Research Center
Full name of responsible person
Nooshafarin Kazemikhoo
Position
Medical Genetics PhD
Other areas of specialty/work
Street address
No 4, Maryam alley, the southern Kamranyeh street, Tehran
City
Tehran
Postal code
14155-6453
Phone
+98 212122212537
Fax
Email
nooshakazemi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin and Stem Cell Research Center
Full name of responsible person
Nooshafarin Kazemikhoo
Position
Medical Genetics PhD
Other areas of specialty/work
Street address
No 4, Maryam alley, the southern Kamranyeh street, Tehran
City
Tehran
Postal code
14155-6453
Phone
+98 21 2220 1710
Fax
Email
nooshakazemi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Skin and Stem Cell Research Center
Full name of responsible person
Fereshteh Ansari
Position
PhD of Epidemiology
Other areas of specialty/work
Street address
No 4, Maryam alley, the southern Kamranyeh street, Tehran
City
Tehran
Postal code
Phone
+98 21 2220 1710
Fax
+98 21 2223 9264
Email
ansarif@ut.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)