Acute Coronary SyndromeNCT05160519
Class IV Laser Therapy on Ejection Fraction, Cardio Biomarkers and Functional Outcomes
A study testing Class IV Laser in people with Acute Coronary Syndrome, run by Asir John Samuel at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Class IV Laser
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 10 Aug 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Tumor or growth around mediastinum,
- Temporary or permanent pacemaker,
- Receiving steroids or photosensitive drugs,
- Pregnancy,
- Epilepsy,
- LVEF ≤ 30%
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Mandeep Kumar Jangra
Ambāla, Haryana, 133207
Mandeep Kr Jangra, MPT
About this study
Official title: 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.
Read the 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
- Being tested
- Class IV Laser, Sham Class IV Laser
- Keywords
- Class IV Laser, ACS, Ejection fraction, Cardiac Biomarkers
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Class IV Laser |
| Sham Controlled | Sham comparator | 30 participants will subject to irradiation but the equipment will be kept off. Receives: Radiation: Sham Class IV Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Ejection Fraction
Left Ventricular ejection fraction is a is a direct indicator of left ventricle systolic function.
Measured: 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
Measured: 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.
Measured: changes will be measured at baseline and on one month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start10 Aug 2022
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asir John Samuel
- Sponsor type
- University, hospital or other
- Collaborators
- Maharishi Markendeswar University (Deemed to be University)
- Responsible party
- Sponsor-investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Mandeep K Jangra, PhD Scholar, Principal investigator, M.M. Institute of Physiotherapy & Rehabilitation, (Maharishi Markandeshwar Deemed to be University)Asir J Samuel, PhD, Study director, M.M. Institute of Physiotherapy & Rehabilitation, (Maharishi Markandeshwar Deemed to be University)Anupam Bhambhani, DM, Study director, MMIMSR, Maharishi Markandeshwar Deemed to be University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160519
- Sponsor's protocol ID
- MMDU/IEC/2157
- Other IDs
- U1111-1270-8393
- Status last verified
- Jan 2023
- First submitted
- 2 Dec 2021
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28181487Kazemi 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.
PubMed 25653805Elbaz-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.
PubMed 29999208Quirk 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.
PubMed 25093393
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Class IV Laser Therapy on Ejection Fraction, Cardio Biomarkers and Functional Outcomes Among Individuals With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT05160519
- Acronym / sponsor ID
- MMDU/IEC/2157
- Conditions
- Acute Coronary Syndrome
- Keywords
- Class IV Laser, ACS, Ejection fraction, Cardiac Biomarkers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Asir John SamuelUniversity, hospital or other
- Collaborators
- Maharishi Markendeswar University (Deemed to be University)
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Radiation: Class IV Laser30 participants will be irradiated with Class IV laser therapy over the left parasternal area to examine the effectiveness of Class IV laser. |
| Sham Controlled | Sham comparator | Radiation: Sham Class IV Laser30 participants will subject to irradiation but the equipment will be kept off. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Tumor or growth around mediastinum,
- Temporary or permanent pacemaker,
- Receiving steroids or photosensitive drugs,
- Pregnancy,
- Epilepsy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Class IV Laser30 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 | Experimental |
| Sham Class IV Laser30 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. | Radiation | Sham Controlled |
Primary outcome
Left Ventricular Ejection Fraction
Time frame: 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 Biomarker
Time frame: changes will be measured at baseline, peak hours (10 hours post revascularization) and on 3rd day post intervention
Cardiac Biomarkers (Troponin I) are the early markers of acute myocardial injury
Functional outcomes
Time frame: changes will be measured at baseline and on one month follow up
Hindi version of Seattle angina Questionnaire will be used to assess functional outcomes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Background: PubMed 28181487Liebert 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.
- Background: PubMed 25653805Kazemi 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.
- Background: PubMed 29999208Elbaz-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.
- Background: PubMed 25093393Quirk 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mandeep K Jangra, PhD Scholar principal investigator
M.M. Institute of Physiotherapy & Rehabilitation, (Maharishi Markandeshwar Deemed to be University)
Asir J Samuel, PhD study director
M.M. Institute of Physiotherapy & Rehabilitation, (Maharishi Markandeshwar Deemed to be University)
Anupam Bhambhani, DM study director
MMIMSR, Maharishi Markandeshwar Deemed to be University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Class IV Laser in people with Acute Coronary Syndrome, run by Asir John Samuel at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mandeep K Jangra, PhD Scholar (9416797708, mjangra708@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Ejection Fraction (time frame: changes will be measured at baseline and on 3rd day post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05160519, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.