Watch Laser Acupuncture With Nasal Radiation for Prevention of Coronary Artery Disease

Laser Hemotherapy Trial for Coronary Artery Disease Prevention in High Risk Patients

This study will evaluate the effect of low level laser blood radiation applied to all participants for prevention of coronary artery disease in patients with high risk (hypertension,high blood viscosity, hypercholesterolemia as well as related immune issues)

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Cardiovascular Risk Factor
• Intervention / Treatment: Device: low level laser hemotherapy

Detailed Description

The areas of low - intensity laser use have expanded in several conditions by different mechanisms and ways. Hypertension as one of coronary artery disease risk factors and early indicator of future cardiovascular events with high blood viscosity and elevated blood cholesterol levels with immune-pathological basis became necessary issue to be handled. Low Level Laser irradiation effects on blood is very essential way in revealing the mechanisms of the action of laser radiation on biological tissues by means of changes in metabolism, leading to molecular, cellular and systemic changes.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dokki
    • Giza, Dokki, Egypt, 11432
      • Cairo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 53 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• stage I hypertensive patients
• patients from 30 to 34.9 kg/m2 body mass index
• medically stable patients
• all participants have sufficient cognition enough to understand the requirements of the study

Exclusion Criteria:

• history of malignant disease
• smoking
• history of progressive fatal disease
• history of drug or alcohol abuse
• blood donation within at least 30 days
• pregnant, trying to be pregnant or breast feeding
• cognitive impairment that will make it difficult to partake in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: low level laser hemotherapy; Watch laser acupuncture and nasal irradiation	Device: low level laser hemotherapy; semiconductor laser therapeutic instrument irradiate the circulating blood in the vessels of left hand acupoint and the mucosal tissue in the nasal cavity; Other Names: Watch laser
No Intervention: control; all the participants in this group did not receive low level laser irradiation during the study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes of blood pressure	measuring blood pressure before and after each low level laser radiation	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in blood viscosity	measuring changes in blood viscosity before and after low level laser radiation session	8 weeks
change in IL-17 level	measuring changes in IL-17 level before and after low level laser radiation session	45 days
change in functional capacity	measuring of 6 minute walking test before and after low level laser irradiation as an indicator of functional capacity improving	70 days
change in CD 8 (cluster of differentiation 8) level	measuring changes in CD 8 (cluster of differentiation 8) level before and after low level laser radiation session	45 days
change in TC (total cholesterol) level	measuring changes in TC (total cholesterol) level before and after low level laser radiation session	60 days
change in LDL (low density lipoprotien) level	measuring changes in LDL (low density lipoprotien) level before and after low level laser radiation session	60 days
change in TG (triglyceride) level	measuring changes in TG (triglyceride) level before and after low level laser radiation session	60 days
change in HDL (high density lipoprotien) level	measuring changes in HDL (high density lipoprotien) level before and after low level laser radiation session	60 days

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Cairo Giza, MD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): August 5, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: February 25, 2018
• First Submitted That Met QC Criteria: March 3, 2018
• First Posted (Actual): March 6, 2018

Study Record Updates

• Last Update Posted (Actual): February 7, 2019
• Last Update Submitted That Met QC Criteria: February 5, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: hypertension; hypercholesterolemia; high blood viscosity
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: P.T.REC/012/001561

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified participated data for underlie results reported in this trial
• IPD Sharing Time Frame: data will be available after 6 months of study completion and ending 36 months
• IPD Sharing Access Criteria: proposals should directed to Dr.EbtesamNagy@cu.edu.eg. To gain access, data requestors will need to sign a data access agreement
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No