Class IV Laser Therapy on Ejection Fraction, Cardio Biomarkers and Functional Outcomes

Class IV Laser Therapy on Ejection Fraction, Cardio Biomarkers and Functional Outcomes Among Individuals With Acute Coronary Syndrome

A total of 60 Individuals with Acute coronary Syndrome who underwent angioplasty with or without stent will be recruited by purposive sampling method in a randomized double-blinded sham controlled trial. Recruited participants will be divided into two group of equal size (n = 30): Sham control group and experimental group by block randomization. The experimental group will subject to Class IV laser therapy along with the standard treatment regime at three spot(s) over the pericardium (left parasternal 2nd, 3rd intercostal space and apex) for a duration of 60 seconds at each point.; immediately after the angioplasty and subsequent two days. Left ventricular ejection fraction will be assessed at base line and after 3 days post-interventions. Cardiac biomarker (Troponin I) will be assessed at base line, peak hours (at 10 hour after revascularization) and on third day post intervention. Function outcomes will be assessed at baseline and at one month follow up.

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Radiation: Class IV Laser; Radiation: Sham Class IV Laser

Detailed Description

Individuals with acute coronary syndrome admitted in the Cardiac Care Unit of MMIMSR, Mullana, Ambala, Haryana who underwent angioplasty with or without stent during the study period will be screened according to selection criteria. Then the invited participants will be asked to sign a written informed consent for voluntarily participation in the study. Participants will be divided into two group of equal size (n = 30): Sham control group and experimental group by block randomization. The researcher will be divided into therapist and evaluator or assessor. The therapist will responsible for conducting the therapy and evaluator or assessor will responsible for assessment of outcome measures both pre and post intervention. All the assessor or evaluator (lab technicians who assess cardiac biomarkers, Cardiologist who perform echocardiography and assess ECG) will be blinded from the grouping of the participants. The participants will also be blinded to the study by use of laser protected eye wears. Left ventricular ejection fraction, cardiac biomarker (Troponin I) and functional outcomes will be assessed at base line. The experimental group will subject to Class IV laser therapy along with the standard treatment regime at three spot(s) over the pericardium (left parasternal 2nd, 3rd intercostal space and apex) for a duration of 60 seconds at each point.; immediately after the angioplasty and subsequent two days. The sham group will subject to irradiation but the equipment will be kept off. All the outcomes measures will be reassess after 3 days post-interventions.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mandeep K Jangra, PhD Scholar; Phone Number: 9416797708; Email: mjangra708@gmail.com

Study Locations

• India
  • Haryana
    • Ambala, Haryana, India, 133207
      • Recruiting
      • Mandeep Kumar Jangra
      • Contact: Mandeep Kr Jangra, MPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Individuals with Acute Coronary Syndrome (ACS) who underwent angioplasty with drug eluting implant
2. Both male and female above 18 years of age,
3. Hemodynamically stable,
4. Who voluntarily signed the informed consent.

Exclusion Criteria:

1. Tumor or growth around mediastinum,
2. Temporary or permanent pacemaker,
3. Receiving steroids or photosensitive drugs,
4. Pregnancy,
5. Epilepsy,
6. LVEF ≤ 30%

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; 30 participants will be irradiated with Class IV laser therapy over the left parasternal area to examine the effectiveness of Class IV laser.	Radiation: Class IV Laser; 30 participants will be irradiated with Class IV laser therapy over the left parasternal area to examine the efficacy of class IV laser on ejection fraction, Cardiac Biomarker and functional outcomes. Device: Litecure LCT-1000C Class IV laser will be used in contact method over the left parasternal area in 2nd, 3rd intercostal space and apex. Dosage and Parameters for the irradiation will be calculated. Parameters: 1. Wavelength: 980nm, 2. Power/ Energy density: 6W/6J/cm2 3. Frequency: CW 4. Energy delivered at each spot: 360J 5. irradiation spots: 3 6. Irradiation time: 60 sec at each spot. Both the patient and laser giver will use the laser protected eye wears to ensure standard practice for the laser.
Sham Comparator: Sham Controlled; 30 participants will subject to irradiation but the equipment will be kept off.	Radiation: Sham Class IV Laser; 30 participants in sham control group will be suppose to irradiate with Class IV laser therapy over the left parasternal area, but the radiation will not be delivered. Device: Litecure LCT-1000C Class IV laser will be placed over the left parasternal area in 2nd, 3rd intercostal space and apex without switching on the instrument. Both the patient and laser giver will use the laser protected eye wears to ensure standard practice for the laser.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left Ventricular Ejection Fraction	Left Ventricular ejection fraction is a is a direct indicator of left ventricle systolic function.	changes will be measured at baseline and on 3rd day post intervention
Cardiac Biomarker	Cardiac Biomarkers (Troponin I) are the early markers of acute myocardial injury	changes will be measured at baseline, peak hours (10 hours post revascularization) and on 3rd day post intervention
Functional outcomes	Hindi version of Seattle angina Questionnaire will be used to assess functional outcomes.	changes will be measured at baseline and on one month follow up

Collaborators and Investigators

• Sponsor: Asir John Samuel
• Collaborators: Maharishi Markendeswar University (Deemed to be University)
• Investigators: Principal Investigator: Mandeep K Jangra, PhD Scholar, M.M. Institute of Physiotherapy & Rehabilitation, (Maharishi Markandeshwar Deemed to be University); Study Director: Asir J Samuel, PhD, M.M. Institute of Physiotherapy & Rehabilitation, (Maharishi Markandeshwar Deemed to be University); Study Director: Anupam Bhambhani, DM, MMIMSR, Maharishi Markandeshwar Deemed to be University

Publications and helpful links

General Publications

• Liebert A, Krause A, Goonetilleke N, Bicknell B, Kiat H. A Role for Photobiomodulation in the Prevention of Myocardial Ischemic Reperfusion Injury: A Systematic Review and Potential Molecular Mechanisms. Sci Rep. 2017 Feb 9;7:42386. doi: 10.1038/srep42386.
• Kazemi Khoo N, Babazadeh K, Lajevardi M, Dabaghian FH, Mostafavi E. Application of Low-Level Laser Therapy Following Coronary Artery Bypass Grafting (CABG) Surgery. J Lasers Med Sci. 2014 Spring;5(2):86-91.
• Elbaz-Greener G, Sud M, Tzuman O, Leitman M, Vered Z, Ben-Dov N, Oron U, Blatt A. Adjunctive laser-stimulated stem-cells therapy to primary reperfusion in acute myocardial infarction in humans: Safety and feasibility study. J Interv Cardiol. 2018 Dec;31(6):711-716. doi: 10.1111/joic.12539. Epub 2018 Jul 12.
• Quirk BJ, Sonowal P, Jazayeri MA, Baker JE, Whelan HT. Cardioprotection from ischemia-reperfusion injury by near-infrared light in rats. Photomed Laser Surg. 2014 Sep;32(9):505-11. doi: 10.1089/pho.2014.3743. Epub 2014 Aug 5.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Anticipated): March 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: ACS; Ejection fraction; Cardiac Biomarkers; Class IV Laser
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: MMDU/IEC/2157; U1111-1270-8393 (Other Identifier: Universal Trial Number (UTN)-WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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