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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.


 
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