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

NCT ID: NCT05160519

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-10
• Study Completion Date: 2023-09-30

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.

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.

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental

30 participants will be irradiated with Class IV laser therapy over the left parasternal area to examine the effectiveness of Class IV laser.

Group Type: EXPERIMENTAL

Class IV Laser

Intervention Type: RADIATION

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 Controlled

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

Group Type: SHAM_COMPARATOR

Sham Class IV Laser

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: RADIATION

Eligibility Criteria

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%

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maharishi Markendeswar University (Deemed to be University)

OTHER

Sponsor Role: collaborator

Asir John Samuel

OTHER

Sponsor Role: lead

Responsible Party

Asir John Samuel

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mandeep K Jangra, PhD Scholar

Role: PRINCIPAL_INVESTIGATOR

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

Asir J Samuel, PhD

Role: STUDY_DIRECTOR

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

Anupam Bhambhani, DM

Role: STUDY_DIRECTOR

MMIMSR, Maharishi Markandeshwar Deemed to be University

Locations

Mandeep Kumar Jangra

Ambāla, Haryana, India

Site Status: RECRUITING

Countries

India

Central Contacts

Mandeep K Jangra, PhD Scholar

Role: CONTACT

mjangra708@gmail.com

9416797708

Asir J Samuel, PhD

Role: CONTACT

asirjohnsamuel@mmumullana.org

8059930222

Facility Contacts

Mandeep Kr Jangra, MPT

Role: primary

References

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Reference Type: BACKGROUND

PMID: 28181487 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25653805 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29999208 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25093393 (View on PubMed)

Other Identifiers

U1111-1270-8393

Identifier Type: OTHER

Identifier Source: secondary_id

MMDU/IEC/2157

Identifier Type: -

Identifier Source: org_study_id