| CTRI Number |
CTRI/2024/04/065315 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
06/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on risk factors, risk predictors, and trigger factors for the development of acute coronary syndrome in newly diagnosed cardiovascular disease patients between 18-45 years of age. |
|
Scientific Title of Study
|
Assessment of risk factors, risk predictors, and trigger factors for the development of acute coronary syndrome in patients between 18-45 years of age- an observational, cross-sectional single center 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 Sandeep Nagorao Patil |
| Designation |
Consultant Cardiologist and HOD (Cardiology Dept) |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
OPD no. 01, 1st Floor, Cardiology Department, Srishti Complex, Bhaktivedanta Swami Marg, Mira road east, Thane, Maharashtra, India
Thane MAHARASHTRA 401107 India |
| Phone |
9324929490 |
| Fax |
|
| Email |
drsandeepnpatil@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sandeep Nagorao Patil |
| Designation |
Consultant Cardiologist and HOD (Cardiology Dept) |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
OPD no. 01, 1st Floor, Cardiology Department, Srishti Complex, Bhaktivedanta Swami Marg, Mira road east, Thane, Maharashtra, India
Thane MAHARASHTRA 401107 India |
| Phone |
9324929490 |
| Fax |
|
| Email |
drsandeepnpatil@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sandeep Nagorao Patil |
| Designation |
Consultant Cardiologist and HOD (Cardiology Dept) |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
OPD no. 01, 1st Floor, Cardiology Department, Srishti Complex, Bhaktivedanta Swami Marg, Mira road east, Thane, Maharashtra, India
Thane MAHARASHTRA 401107 India |
| Phone |
9324929490 |
| Fax |
|
| Email |
drsandeepnpatil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhaktivedanta Hospital and Research Institute, Bhaktivedanta Swami Marg, Sector 6, Sector 1, Srishti Complex, Mira Road, Thane, Maharashtra, India 401107 |
|
|
Primary Sponsor
|
| Name |
Bhaktivedanta Hospital and Research Institute |
| Address |
Srishti Complex, Bhaktivedanta Swami Marg, Mira road east, Thane,401107, Maharashtra, India. |
| 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 |
| Dr Sandeep Patil |
Bhaktivedanta Hospital and Research Institute |
OPD no. 01, 1st Floor, Cardiology Department, Srishti Complex, Bhaktivedanta Swami Marg, Mira road east, Thane,401107, Maharashtra, India Thane MAHARASHTRA |
9324929490
drsandeepnpatil@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: I229||Subsequent ST elevation (STEMI) myocardial infarction of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. IPD Patients in the age group of 18-45 years and of all genders
2. Patients who are newly diagnosed with unstable angina, STEMI, NSTEMI by a cardiologist and agreed to participate
|
|
| ExclusionCriteria |
| Details |
1. Patients having previous history of ACS and undergone any treatment for ACS.
2. Patients having connective tissue disorders (Chronic inflammation and rheumatological disorders).
3. Patients having CKD, psychiatric illness, any type of cancers.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The present study designed will elucidate these lacunae in the risk profile of the younger ACS patients. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="193" Sample Size from India="193"
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)
|
14/04/2024 |
| 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="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Acute coronary syndrome (ACS) refers to a range of clinical presentations almost always associated with rupture of an atherosclerotic plaque in a coronary artery with subsequent partial or complete thrombosis. The syndrome includes unstable angina (UA), non–ST-segment elevation myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI). It is reported that individuals from Indian subcontinent may develop coronary artery disease (CAD) at a higher rate and at an early age. Onset of CAD before 40 y of age is considered as premature CAD. Although majority of studies reported that only about 3% of all CAD cases occur in <40 y of age, it should be considered as the ‘tip of the iceberg’ as young, asymptomatic patients usually do not undergo medical investigations. The Objective of the study is to assess different risk factors for the development of ACS, trigger factors and risk predictors for cardiovascular events like ACS.
Patient reporting to the Emergency Department and has been diagnosed with ACS by Cardiologist and if they fit the eligibility criteria, will be included in the study. As per SOC, all necessary investigations will be performed along with required treatment and once the patient is stabilize and is shifted to ward, informed consent will be taken. Post consent, all study related necessary questionnaires will be administered by the study team, and the sensitive questions would not be asked to the study participants. The questions will be administered on 3rd day of hospitalization to the study participants in the following sequence: Diet, METS(Metabolic equivalent, PSQI (Pittsburgh Sleep Quality Index), SF-36 ( Short Form Health Survey), PSS (Perceived Stress Scale), Anger onset scale , PANAS ( Positive and Negative Affect Schedule). To assess risk factors- Perceived stress scale, Pittsburgh Sleep Quality Index, SF-36 questionnaire, diet questionnaire. To assess trigger factors- Anger onset scale, PANAS, METS. To assess risk predictors- lab tests done as per SOC are recorded. The following data parameters will be recorded: Patient ID, Age, Gender , Occupation Diagnosis, Any substance abuse (Yes/No), specify:, Smoking (Y/N):, Alcohol consumption (Yes/No), specify frequency:, Medical history:, Covid-19 history, Covid vaccine history, Diabetes (Yes/no), Family h/o diabetes. Obesity (BMI), waist circumference., dyslipidemia (Yes/no), Family h/o dyslipidaemia, Hypertension (Yes/no), Family h/o hypertension, Family h/o IHD, History of OSA, Standard of care lab investigations. The endpoint of study is to elucidate these lacunae in the risk profile of the younger ACS patients. |