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

Asir John Samuel

Status: Enrolling

Conditions: Acute Coronary Syndrome

Treatments: Radiation: Class IV Laser; Radiation: Sham Class IV Laser

Study type: Interventional

Funder types: Other

Identifiers

NCT05160519

MMDU/IEC/2157

U1111-1270-8393 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Experimental

Experimental group

Description:

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

Treatment:

Radiation: Class IV Laser

Sham Controlled

Sham Comparator group

Description:

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

Treatment:

Radiation: Sham Class IV Laser