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

March 10, 2016 updated by: Rodrigo Della Méa Plentz, Federal University of Health Science of Porto Alegre

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Health Science of Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

February 18, 2016

First Submitted That Met QC Criteria

March 10, 2016

First Posted (Estimate)

March 16, 2016

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 10, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LLLT-CABG-2016/2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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