| CTRI Number |
CTRI/2024/04/065351 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate sleep pattern & its correlation in acute coronary syndrome patients. |
|
Scientific Title of Study
|
Qualitative and quantitative assessment of sleep in acute coronary syndrome patients and its correlation with the risk of acute coronary event- A cross sectional observational study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harikrishna Sharma M |
| Designation |
Dnb General Medicine |
| Affiliation |
Bhaktivedanta Hospital & Research Institute |
| Address |
Dept of General Medicine,Opd no 13,Ground floor,Srishti Complex, Bhaktivedanta Swami Marg, Mira Road
Thane
MAHARASHTRA
401107
India |
| Phone |
7760019026 |
| Fax |
|
| Email |
harikrishnahari4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhawal Dalal |
| Designation |
Hod Dept Of General Medicine |
| Affiliation |
Bhaktivedanta Hospital & Research Institute |
| Address |
opd no 13,Ground floor,Shrishti complex,Bhaktivedanta Swami Marg, Mira Road East
Thane
MAHARASHTRA
401107
India |
| Phone |
9322220944 |
| Fax |
|
| Email |
drdalal.rns@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harikrishna Sharma M |
| Designation |
Dnb General Medicine |
| Affiliation |
Bhaktivedanta Hospital & Research Institute |
| Address |
Dept of General Medicine,Opd no 13,Ground floor,Srishti Complex, Bhaktivedanta Swami Marg, Mira Road
Thane
MAHARASHTRA
401107
India |
| Phone |
7760019026 |
| Fax |
|
| Email |
harikrishnahari4@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bhaktivedanta Hospital & Research Institute |
| Address |
Bhaktivedanta Swami Marg, Sector 1, Srishti Complex, Mira Road East, Mira Bhayandar, Maharashtra 401107 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| HARIKRISHNA SHARMA M |
Bhaktivedanta Hospital & Research Institute |
Dept of General Medcine,opd no 13,Ground floor,old building
Thane
MAHARASHTRA |
7760019026
harikrishnahari4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaktivedanta Hospital Ethics Committee for Biomedical and Health research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. All cases of Acute Coronary Syndrome getting admitted in Bhaktivedantha Hospital,
who consent for the study
2. All genders with age group between 25 to 80 years. |
|
| ExclusionCriteria |
| Details |
1. Age group of less than 25 years & more than 80 years
2. All those who don’t consent for the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Study the effects of qualitative & quantitative sleep deprivation on Risk of Acute Coronary Syndrome.& To Assess the quality of sleep in Acute Coronary syndrome patients & its impact on
Ischaemic heart disease. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the quality of sleep in Acute Coronary Syndrome patients & its impact on Ischaemic heart disease |
18 months |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/04/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM: To study the impact of Sleep deprivation on Acute Coronary Syndrome. OBJECTIVES : 1. To Study the effects of qualitative & quantitative sleep deprivation on Risk of Acute Coronary Syndrome. 2. To Assess the quality of sleep in Acute Coronary syndrome patients & its impact on Ischaemic heart disease.
STUDY DESIGN : Single centre cross sectional observational study.
This Prospective comparative study will be conducted after approval from the Institutional Ethical Committee (IEC). The study will be conducted in the department of General Medicine and Cardiology at Bhaktivedanta Hospital and Research institute. All patients meeting the above-mentioned study criteria and willing to provide written informed consent for participation will be enrolled in the study.Detailed medical history of every participant will be taken & then they will be interviewed using Pittsburg Sleep Quality Index(PSQI) questionnaire.Their medical records will be collected from the In Patient Case sheets. After the detailed recording of data,statistical analysis will be done & then corelation between Sleep Deprivation & acute coronary syndrome & its risk factors will be calculated. Those found to have poor sleep quality & having disturbed sleep ,will be educated about the importance of adequate sleep & counselled regarding healthy sleep practices.
|