Effects of the Low-level Laser Therapy on Inflammatory Profile of the Patients With Coronary Artery Bypass Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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This study will be conducing in a large hospital that is reference in Cardiovascular diseases treatments. 38 patients will be randomized for placebo or 6J low-level laser therapy (LLLT). The inflammatory profile and cardiac tissue will be assessment before and after de LLLT.

Official Title
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Effects of the Low-level Laser Therapy on Inflammatory Profile on Patients With Coronary Artery Bypass Surgery: A Randomized, Controlled Clinical Trail

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Device: 0J LLLT
* Device: 6J LLLT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: 0J LLLT<br>The intervention will be made with the machine off. | Device: 0J LLLT<br>* perform with the machine off<br>* Other names: Sham Low-Level Laser Therapy (Sham LLLT);|
| Experimental: 6J LLLT<br>The Laser radiation will be made with 4J by spot | Device: 6J LLLT<br>* irradiation will be perform with 4J<br>* Other names: 4J Low-Level Laser Therapy (4J LLLT);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cytokine IL-10 |  | six days | 
| cytokine IL-6 |  | six days | 
| cytokine TNF-α |  | six days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Troponin |  | six days | 
| Creatine phosphokinase (CK) |  | six days | 
| Lactate dehydrogenase (LDH) |  | six days | 
| Complete blood count |  | six days | 
| Visual Analog scale |  | six days | 
| Hospital stay |  | six days | 
| Pulmonary complications |  | six days |