Effects of the Low-level Laser Therapy on Inflammatory Profile of the Patients With Coronary Artery Bypass Surgery
1 other identifier
interventional
38
0 countries
N/A
Brief Summary
Cardiovascular diseases are the leading causes of morbidity and mortality in Brazil and surgical procedures to treat these disorders have grown dramatically in recent years. Since the first heart surgery in successful open field in humans, conducted in 1953 by John Lewis, many techniques have been used to improve the outcome of surgery and reduce their side effects. The low-level laser therapy (LBP) has been widely used in clinical practice for pain relief purposes, reducing inflammation and stimulating tissue healing. However, the effect of this therapy has been little elucidated in patients with cardiac disease. The objective of this study is to evaluate the effect of low level laser therapy on the inflammatory profile and cardiac tissue healing markers of patients in the postoperative period of CABG surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable cardiovascular-diseases
Started Mar 2016
Shorter than P25 for not_applicable cardiovascular-diseases
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 16, 2016
March 1, 2016
6 months
February 18, 2016
March 10, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
cytokine IL-10
six days
cytokine IL-6
six days
cytokine TNF-α
six days
Secondary Outcomes (7)
Troponin
six days
Creatine phosphokinase (CK)
six days
Lactate dehydrogenase (LDH)
six days
Complete blood count
six days
Visual Analog scale
six days
- +2 more secondary outcomes
Study Arms (2)
0J LLLT
SHAM COMPARATORThe intervention will be made with the machine off.
6J LLLT
EXPERIMENTALThe Laser radiation will be made with 4J by spot
Interventions
Eligibility Criteria
You may qualify if:
- Patients after elective coronary artery bypass surgery, hemodynamically stable, without ischemic changes and / or complex arrhythmias on the electrocardiogram, between 45 and 75 years of age, who have performed the first surgery
You may not qualify if:
- Patients with decompensated heart failure; other associated surgery; presence of any comorbidity such as: unstable angina; sequel of stroke; photosensitivity; use of cardiac pacemaker; Diabetes mellitus (due to the negative effect of diabetes on wound healing).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Research
Study Record Dates
First Submitted
February 18, 2016
First Posted
March 16, 2016
Study Start
March 1, 2016
Primary Completion
September 1, 2016
Study Completion
December 1, 2016
Last Updated
March 16, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share