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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02709499
• Other study ID #: LLLT-CABG-2016/2
• Status: Not yet recruiting
• Phase: N/A
• First received: February 18, 2016
• Last updated: March 10, 2016
• Start date: March 2016
• Est. completion date: December 2016

Study information

• Verified date: March 2016
• Source: Federal University of Health Science of Porto Alegre
• Contact: Rodrigo DM Plentz, PhD
• Phone: +55 51 33038835
• Email: roplentz[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Device:
• 0J LLLT
perform with the machine off
• 6J LLLT
irradiation will be perform with 4J

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cytokine IL-10		six days	No
Primary	cytokine IL-6		six days	No
Primary	cytokine TNF-a		six days	No
Secondary	Troponin		six days	No
Secondary	Creatine phosphokinase (CK)		six days	No
Secondary	Lactate dehydrogenase (LDH)		six days	No
Secondary	Complete blood count		six days	No
Secondary	Visual Analog scale		six days	No
Secondary	Hospital stay		six days	No
Secondary	Pulmonary complications		six days	No