Ignite Creation Date:
2024-05-06 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05160519
Status:
RECRUITING
Last Update Posted:
2023-01-11
First Post:
2021-12-02
Brief Title:
Class IV Laser Therapy on Ejection Fraction Cardio Biomarkers and Functional Outcomes
Sponsor:
Asir John Samuel
Organization:
Maharishi Markendeswar University Deemed to be University
Study Overview
Official Title:
Class IV Laser Therapy on Ejection Fraction Cardio Biomarkers and Functional Outcomes Among Individuals With Acute Coronary Syndrome
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 spots 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 spots 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1270-8393 | OTHER | Universal Trial Number UTN-WHO | None |