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

NCT ID: NCT02709499

Last Updated: 2016-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-12-31

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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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0J LLLT

The intervention will be made with the machine off.

Group Type SHAM_COMPARATOR

0J LLLT

Intervention Type DEVICE

perform with the machine off

6J LLLT

The Laser radiation will be made with 4J by spot

Group Type EXPERIMENTAL

6J LLLT

Intervention Type DEVICE

irradiation will be perform with 4J

Interventions

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0J LLLT

perform with the machine off

Intervention Type DEVICE

6J LLLT

irradiation will be perform with 4J

Intervention Type DEVICE

Other Intervention Names

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Sham Low-Level Laser Therapy (Sham LLLT) 4J Low-Level Laser Therapy (4J LLLT)

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).
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Rodrigo Della Méa Plentz

Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Rodrigo DM Plentz, PhD

Role: CONTACT

+55 51 33038835

Rodrigo DM Plentz, PhD

Role: CONTACT

+55 51 33018835

Other Identifiers

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LLLT-CABG-2016/2

Identifier Type: -

Identifier Source: org_study_id

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