FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/092597 [Registered on: 07/08/2025] Trial Registered Prospectively
Last Modified On: 06/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Other 
Public Title of Study   Does Breathing Polluted Air Increase the Risk of Heart Problems? A Study in Heart Attack Patients 
Scientific Title of Study   Cardiovascular Acute event risk from PolluTion exposURE in ACS patients (CAPTURE-ACS study): A Prospective, Quasi-Experimental Observational Study  
Trial Acronym  CAPTURE-ACS study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Yashendra Sethi 
Designation  Junior Resident 
Affiliation  Subharti Medical College 
Address  Post Graduate Department of Medicine, Subharti Medical College and CSSH, Subhartipuram, NH-58, Delhi-Haridwar Bypass Road, Meerut, Uttar Pradesh, 250005.

Meerut
UTTAR PRADESH
250005
India 
Phone  8923489772  
Fax    
Email  yashendrasethi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Amit Kumar Ahlawat 
Designation  Professor 
Affiliation  Subharti Medical College 
Address  Post Graduate Department of Medicine, Subharti Medical College, Subhartipuram, NH-58, Delhi-Haridwar Bypass Road, Meerut, Uttar Pradesh, 250005.


UTTAR PRADESH
250005
India 
Phone  8923489772  
Fax    
Email  amitahlawat7520@gmail.com  
 
Details of Contact Person
Public Query  
Name  Yashendra Sethi 
Designation  Junior Resident 
Affiliation  Subharti Medical College 
Address  Post Graduate Department of Medicine, Subharti Medical College, Subhartipuram, NH-58, Delhi-Haridwar Bypass Road, Meerut, Uttar Pradesh, 250005.


UTTAR PRADESH
250005
India 
Phone  8923489772  
Fax    
Email  yashendrasethi@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Subharti Medical College 
Address  Subharti Medical College, Subhartipuram, NH-58, Delhi-Haridwar Bypass Road, Meerut, Uttar Pradesh, 250005. 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
PearResearch  67/31 Tyagi Road, Dehradun, India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Yashendra Sethi  SUBHARTI MEDICAL COLLEGE and Chhatrapati Shivaji Subharti Hospital  Post Graduate Department of Medicine, Subharti Medical College, Subhartipuram, NH-58, Delhi-Haridwar Bypass Road, Meerut, Uttar Pradesh, 250005
Meerut
UTTAR PRADESH 		 8923489772

yashendrasethi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
University Ethics Committee, Subharti Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Different and Changing levels of Pollutants act as Quasi-interventions   We are conducting a Prospective, Quasi-Experimental Observational Study where we observe ACS patients and associate that with acute and chronic exposure to air pollutants (varying levels of which act as an intervention here) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adults 18 years or more with ACS confirmed per Fourth Universal Definition of ACS
 
 
ExclusionCriteria 
Details  • Type 2 MI (per ESC 2023 guidelines)
• Takotsubo cardiomyopathy
• Chronic inflammatory or autoimmune diseases
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To quantify the association between short term ambient pollutant exposure 1, 7 and 15 days prior to admission, long term exposure more than 12 months prior to the index event and ACS incidence in a high pollution, urban Indian cohort  To quantify the association between short term ambient pollutant exposure 1, 7 and 15 days prior to admission, long term exposure more than 12 months prior to the index event and ACS incidence in a high pollution, urban Indian cohort 
 
Secondary Outcome  
Outcome  TimePoints 
To stratify ACS severity (Killip class, STEMI vs NSTEMI prevalence) across Air Quality Index categories  Baseline, 1 week, 15 days, 30 days, 1 year 
To model dose-response relationships between PM exposure lag 0–2 days & exposure to other pollutants & inflammatory biomarkers hs-CRP, IL-6 using Generalized Additive Models  Baseline, 1 week, 15 days, 30 days, 1 year 
To assess whether PM exposure thresholds (25th vs. 75th percentile) predict in-hospital mortality & Left Ventricular Ejection Fraction reduction   Baseline, 1 week, 15 days, 30 days, 1 year 
To evaluate the association of co-morbdities & confounders like smoking, diabetes, hypertension & dyslipidemia on effect of air pollution on ACS  Baseline 
To assess TIMI thrombus grade variation with prior 3-day PM averages  3 days 
To analyze short-term (30-day) MACE rates across AQI quartiles  30 days 
To compare IL-6 & hs-CRP levels & other biomarkers in ACS patients admitted during ‘severe pollution’ vs. ‘good air quality’ days  Baseline, 1 week, 15 days, 30 days, 1 year 
To evaluate the association between NO exposure & arrhythmia occurrence during hospitalization  Baseline, 1 week, 15 days, 30 days, 1 year 
To determine pollutant-specific risk contribution to ACS subtypes  Baseline, 1 week, 15 days, 30 days, 1 year 
To explore geospatial exposure gradients using inverse distance weighted pollution estimates & their association with ACS outcomes  Baseline, 1 week, 15 days, 30 days, 1 year 
To explore role of seasonal & temporal variations & their association with ACS incidence & outcomes  Baseline, 1 week, 15 days, 30 days, 1 year 
To validate the feasibility of integrating environmental exposure data into ACS risk stratification models in Indian tertiary centers The Mehta-Sethi Score  Baseline, 1 week, 15 days, 30 days, 1 year 
 
Target Sample Size   Total Sample Size="320"
Sample Size from India="320" 
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)   30/08/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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  

This study will delineate the acute effects of ambient air pollution on ACS incidence, severity, biomarkers, and short-term outcomes in India’s high-risk urban populations. It could shape region-specific cardiovascular prevention strategies, inform risk prediction models, and guide public health policies on air quality management.

 
Close