| CTRI Number |
CTRI/2025/03/082119 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of cardiovascular disease related distress and psychosocial
determinants: A prospective observational study |
|
Scientific Title of Study
|
Assessment of cardiovascular disease related distress and psychosocial
determinants: A prospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC/BU/157/Faculty/9/352/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kushal Pujara |
| Designation |
Adult Interventional Cardiologist |
| Affiliation |
B and M Patel Cardiac Centre Shree Krishna Hospital and Pramukh Swami Medical College Karamsad |
| Address |
B and M Patel Cardiac Centre
Shree Krishna Hospital and Pramukh Swami Medical College Karamsad
Gokal Nagar, Karamsad, Anand, Gujarat 388325
Anand
GUJARAT
388325
India |
| Phone |
9825175197 |
| Fax |
|
| Email |
drkushalpujara@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kushal Pujara |
| Designation |
Adult Interventional Cardiologist |
| Affiliation |
B and M Patel Cardiac Centre Shree Krishna Hospital and Pramukh Swami Medical College Karamsad |
| Address |
B and M Patel Cardiac Centre
Shree Krishna Hospital and Pramukh Swami Medical College Karamsad
Gokal Nagar, Karamsad, Anand, Gujarat 388325
Anand
GUJARAT
388325
India |
| Phone |
9825175197 |
| Fax |
|
| Email |
drkushalpujara@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arshi Panchal |
| Designation |
Assistant Professor |
| Affiliation |
Anand Pharmacy College opposite Town Hall Rahtlav Mathiya Chora Anand Gujarat 388001 |
| Address |
Anand Pharmacy College opposite Town Hall Rahtlav Mathiya Chora Anand Gujarat 388001
Anand
GUJARAT
388001
India |
| Phone |
7284856263 |
| Fax |
|
| Email |
arshipanchal99@gmail.com |
|
|
Source of Monetary or Material Support
|
| PRAMUKHSWAMI MEDICAL COLLEGE AND SHREE KRISHNA HOSPITAL KARAMSAD ANAND GUJARAT |
|
|
Primary Sponsor
|
| Name |
DR KUSHAL PUJARA |
| Address |
B and M Patel Cardiac Centre
Shree Krishna Hospital and Pramukh Swami Medical College, Karamsad |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DR KUSHAL PUJARA |
Shree Krishna Hospital and Pramukh Swami Medical College, Karamsad |
B and M Patel Cardiac Centre Shree Krishna Hospital and Pramukhswami Medical College, Anand-Sojitra Rd, Gokul Nagar, Karamsad, Anand, Gujarat
Anand
GUJARAT |
9825175197
drkushalpujara@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-2 HM PATEL CENTER FOR MEDICAL CARE AND EDCUATION KARAMSAD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I220||Subsequent ST elevation (STEMI) myocardial infarction of anterior wall, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NO INTERVENTION |
NO INTERVENTION |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to provide informed consent
Patients above 18 years of age
Patients with primary diagnosis of Acute Coronary Syndrome (Unstable angina, NSTEMI, STEMI)
Both Male and female patients are eligible |
|
| ExclusionCriteria |
| Details |
Patients unwilling to provide consent
Patients with a history of any major surgery less than a month ago or undergoing a surgery
Patients who are Pregnant or lactating
Psychiatric patients with hindered mental capacity |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To measure the levels of distress related to cardiovascular condition.
To study
the impact of socio-economic status and psychosocial determinants on cardiovascular disease related
distress. |
15 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To measure the impact of
polypharmacy on cardiovascular disease related distress. |
15 months |
To prepare and validate Cardiac Distress
Inventory (CDI) and Adherence in Chronic Disease Scale (ACDS) in vernacular language (Gujarati) |
15 months |
| To assess the level of medication adherence |
15 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
24/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Cardiovascular disease (CVD) is a major health concern globally and in India contributing significantly to morbidity and mortality. While medical treatments and surgical interventions have advanced the psychosocial aspects of CVD such as patient distress and its impact on outcomes are less understood and thus often neglected. This study aims to address this gap by systematically evaluating the distress experienced by CVD patients. Understanding these relationships is crucial for developing holistic care strategies that encompasses both physical and psychological impacts ultimately aiming to improve patient management, enhance the quality of life and reduce the burden of CVD related distress.
|