Class IV Laser Therapy on Ejection Fraction, Cardio Biomarkers and Functional Outcomes
Study Details
Study Description
Brief Summary
A total of 86 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 = 43): 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, cardiac biomarkers (CK-MB & Troponin I) and functional outcomes will be assessed at base line and after 3 days post-interventions.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 their voluntarily participation in the study. Participants will be divided into two group of equal size (n = 43): 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 biomarkers (CK-MB & Troponin
- 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental 43 participants will be irradiated with Class IV laser therapy over the left parasternal area to improve ejection fraction, cardio biomarkers. |
Radiation: Class IV Laser
43 participants will be irradiated with Class IV laser therapy over the left parasternal area to improve ejection fraction, cardio biomarkers.
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: 2500Hz 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 43 participants will subject to irradiation but the equipment will be kept off. |
Radiation: Sham Class IV Laser
43 participants will be irradiated with Class IV laser therapy over the left parasternal area to improve ejection fraction, cardio biomarkers.
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.
|
Outcome Measures
Primary Outcome Measures
- Left Ventricular Ejection Fraction [changes will be measured at baseline and on 3rd day post intervention]
Left Ventricular ejection fraction is a is a direct indicator of left ventricle systolic function.
- Cardiac Biomarkers [changes will be measured at baseline and on 3rd day post intervention]
Cardiac Biomarkers (CK-MB, Troponin I) are the early markers of acute myocardial injury
- Functional outcomes [changes will be measured at baseline and on 3rd day post intervention]
Hindi version of Seattle angina Questionnaire will be used to assess functional outcomes
Eligibility Criteria
Criteria
Inclusion Criteria:
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Individuals with Acute Coronary Syndrome (ACS) who underwent angioplasty with or without stent,
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Both male and female above 18 years of age,
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Hemodynamically stable,
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Who voluntarily signed the informed consent.
Exclusion Criteria:
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Tumor or growth around mediastinum,
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Temporary or permanent pacemaker,
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Receiving steroids or photosensitive drugs,
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Pregnancy,
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Epilepsy,
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LVEF ≤ 30%
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Asir John Samuel
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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. Review.
- 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.
- MMDU/IEC/2157
- U1111-1270-8393