LED Photobiomodulation Improves Radial Artery Vascular Function in Vitro

NCT ID: NCT07041697

Last Updated: 2025-06-27

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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-12

Study Completion Date

2025-02-21

Brief Summary

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LED photobiomodulation therapy (PBMT) is widely recognized for its beneficial effects in several clinical conditions; however, its potential in modulating vascular function is not yet fully established. Objective: This study aimed to evaluate the application of PBMT by LED (light-emittion diode) using a combined red and near-infrared light spectrum, with a focus on improving the vascular function of the radial artery in vitro. Methodology: A total of 30 radial artery segments were studied and divided into three groups of 10 segments: the PBMT LED group combined with red and infrared light (R + IR), the red light (R) group, and the infrared light (IR) group. Prior to light irradiation at wavelengths of 650 nm and 940 nm, vascular function in these segments was pharmacologically inhibited using L-NAME. The drugs phenylephrine, acetylcholine, and sodium nitroprusside were used to determine if irradiation could restore the inhibited vascular functions. Superoxide anion levels, an important reactive oxygen specie (ROS), were measured using a chemiluminescence assay with lucigenin. The bioavailability of nitric oxide was evaluated using a Griess Reagent Kit assay, while nitric oxide production was assessed through the DAF fluorescence assay. The vascular inflammation was determined by the Intercellular Adhesion Molecule 1 (ICAM-1) expression.

Detailed Description

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Conditions

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Vascular Dysfunction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

To irradiate the arteries, we used a 14 cm × 14 cm LED blanket composed of 30 red-spectrum LEDs (wavelength: 650 nm), delivering a power density of 1.9 mW/cm² and an energy density of 1.7 J/cm² over an irradiation period of 83 seconds. A separate 14 cm × 14 cm infrared LED blanket, also containing 30 LEDs (wavelength: 940 nm), delivered a power density of 1.7 mW/cm² and an energy density of 1.7 J/cm² with an irradiation time of 94 seconds. Additionally, a 14 cm × 14 cm mixed LED blanket, consisting of 18 red (650 nm) and 18 infrared (940 nm) LEDs, provided a power density of 1.7 mW/cm² and an energy density of 0.16 J/cm² over an irradiation period of 73 seconds.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Photobiomodulation Using Red LED Light at 650 nm Wavelength

The three arms of the study aim to evaluate the effectiveness of different LED light spectra on vasodilation.

Group Type EXPERIMENTAL

Light-emitting diode photobiomodulation therapy

Intervention Type DEVICE

For the intervention, the isolated arteries were assigned to three experimental groups. The first group (red) was exposed to light at a wavelength of 650 nm for 83 seconds. The second group (infrared) received irradiation at 940 nm for 94 seconds. The third group (mixed) was irradiated with a combination of red (650 nm) and infrared (940 nm) light for 73 seconds.

Photobiomodulation Using Red LED Light at 940 nm Wavelength

The three arms of the study aim to evaluate the effectiveness of different LED light spectra on vasodilation.

Group Type EXPERIMENTAL

Light-emitting diode photobiomodulation therapy

Intervention Type DEVICE

For the intervention, the isolated arteries were assigned to three experimental groups. The first group (red) was exposed to light at a wavelength of 650 nm for 83 seconds. The second group (infrared) received irradiation at 940 nm for 94 seconds. The third group (mixed) was irradiated with a combination of red (650 nm) and infrared (940 nm) light for 73 seconds.

Photobiomodulation with Combined Red (650 nm) and Infrared (940 nm) LED Light

The three arms of the study aim to evaluate the effectiveness of different LED light spectra on vasodilation.

Group Type EXPERIMENTAL

Light-emitting diode photobiomodulation therapy

Intervention Type DEVICE

For the intervention, the isolated arteries were assigned to three experimental groups. The first group (red) was exposed to light at a wavelength of 650 nm for 83 seconds. The second group (infrared) received irradiation at 940 nm for 94 seconds. The third group (mixed) was irradiated with a combination of red (650 nm) and infrared (940 nm) light for 73 seconds.

Interventions

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Light-emitting diode photobiomodulation therapy

For the intervention, the isolated arteries were assigned to three experimental groups. The first group (red) was exposed to light at a wavelength of 650 nm for 83 seconds. The second group (infrared) received irradiation at 940 nm for 94 seconds. The third group (mixed) was irradiated with a combination of red (650 nm) and infrared (940 nm) light for 73 seconds.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing coronary artery bypass grafting using the radial artery

Exclusion Criteria

* Patients with poorly compliant radial arteries or those who underwent coronary artery bypass grafting without use of the radial artery were excluded from the study
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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André Timóteo Sapalo

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of São Paulo Medical School in Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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4.829.712

Identifier Type: -

Identifier Source: org_study_id

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