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

Summary

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.

Conditions

• Acute Coronary Syndrome

Interventions

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.

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.

Sponsors & Collaborators

• Maharishi Markendeswar University (Deemed to be University)

  collaborator OTHER

• Asir John Samuel

  lead OTHER

Principal Investigators

• Mandeep K Jangra, PhD Scholar · M.M. Institute of Physiotherapy & Rehabilitation, (Maharishi Markandeshwar Deemed to be University)

• Asir J Samuel, PhD · M.M. Institute of Physiotherapy & Rehabilitation, (Maharishi Markandeshwar Deemed to be University)

• Anupam Bhambhani, DM · MMIMSR, Maharishi Markandeshwar Deemed to be University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-10

Primary Completion

2023-03-30

Completion

2023-09-30

Countries

• India

Study Locations