NCT05160519

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

August 10, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

December 2, 2021

Last Update Submit

January 10, 2023

Conditions

Acute Coronary Syndrome

Keywords

Class IV LaserACSEjection fractionCardiac Biomarkers

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

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

Sham Controlled

SHAM COMPARATOR

30 participants will subject to irradiation but the equipment will be kept off.

Radiation: Sham Class IV Laser

Interventions

Class IV LaserRADIATION

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.

Experimental
Sham Class IV LaserRADIATION

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.

Sham Controlled

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Tumor or growth around mediastinum,
  • Temporary or permanent pacemaker,
  • Receiving steroids or photosensitive drugs,
  • Pregnancy,
  • Epilepsy,
  • LVEF ≤ 30%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mandeep Kumar Jangra

Ambāla, Haryana, 133207, India

RECRUITING

Related Publications (4)

  • 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.

    PMID: 28181487BACKGROUND

  • 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.

    PMID: 25653805BACKGROUND

  • 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.

    PMID: 29999208BACKGROUND

  • 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.

    PMID: 25093393BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Mandeep K Jangra, PhD Scholar

    M.M. Institute of Physiotherapy & Rehabilitation, (Maharishi Markandeshwar Deemed to be University)

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Central Study Contacts

Mandeep K Jangra, PhD Scholar

CONTACT

9416797708mjangra708@gmail.com

Asir J Samuel, PhD

CONTACT

8059930222asirjohnsamuel@mmumullana.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 2, 2021

First Posted

December 16, 2021

Study Start

August 10, 2022

Primary Completion

March 30, 2023

Study Completion

September 30, 2023

Last Updated

January 11, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)