FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/10/095527 [Registered on: 01/10/2025] Trial Registered Prospectively
Last Modified On: 30/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   How Indoor and Outdoor Air Pollution Affects Heart Patients in Punjab: A Follow-Up Study 
Scientific Title of Study   Incidence of Coronary Artery Disease Worsening Events in Patients Exposed to Indoor and Ambient Air Pollution: A Prospective Cohort Study from two Districts of Punjab. 
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 Madhur Verma  
Designation  Associate Professor  
Affiliation  All India Institute of Medical Sciences, Bathinda 
Address  Room No 413, Department of Community and Family Medicine, third floor, A-block, Medical College Building, AIIMS Bathinda, Jodhpur Romana
Jodhpur romana, Mandi Dabwali Road, Bathinda
Bathinda
PUNJAB
151001
India 
Phone  9466445513  
Fax    
Email  drmadhurverma@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Madhur Verma  
Designation  Associate Professor  
Affiliation  All India Institute of Medical Sciences, Bathinda 
Address  Room No 413, Department of Community and Family Medicine, third floor, A-block, Medical College Building, AIIMS Bathinda, Jodhpur Romana
Jodhpur romana, Mandi Dabwali Road, Bathinda
Bathinda
PUNJAB
151001
India 
Phone  9466445513  
Fax    
Email  drmadhurverma@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Madhur Verma  
Designation  Associate Professor  
Affiliation  All India Institute of Medical Sciences, Bathinda 
Address  Room No 413, Department of Community and Family Medicine, third floor, A-block, Medical College Building, AIIMS Bathinda, Jodhpur Romana
Jodhpur romana, Mandi Dabwali Road, Bathinda
Bathinda
PUNJAB
151001
India 
Phone  9466445513  
Fax    
Email  drmadhurverma@gmail.com  
 
Source of Monetary or Material Support  
Stiching blockchain for impact foundation. Address Queens Tower, Delflandlaan 1, 1062 EA Amsterdam, the Netherlands Primary Contact Mr. Sandeep Nailwal Chairman sandeep@blockchainforimpact.nl, Mob 91 9819989954 
 
Primary Sponsor  
Name  Stiching blockchain for impact foundation 
Address  Mr. Sandeep Nailwal, Chairman, sandeep@blockchainforimpact.nl Queens Tower, Delflandlaan 1, 1062 EA Amsterdam, the Netherlands Mob 91 9819989954 
Type of Sponsor  Other [Foundation] 
 
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 Madhur Verma   All India Institute of Medical Sciences, Bathinda  Room No 413, Department of Community and Family medicine, third floor (A-block), Medical College Buidling, AIIMS Bathinda, Jodhpur romana, Bathinda (Punjab), India- 151001
Bathinda
PUNJAB 		 9466445513

drmadhurverma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences Bathinda  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  Nil  Nil 
 
Inclusion Criteria  
Age From  55.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Residing in the study area for at least one year before the onset of the index cardiac event.

A history of CAD diagnosis confirmed by physician or admission to hospital due to Chest pain (angina), Shortness of breath, Fatigue, or Heart attack, or currently on medical management.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Temporal changes in biochemical, physiological and clinical parameters over the study period.

Changes attributed to exposure relative to the non-exposed group.

Association between environmental exposure and clinical outcomes over the study period.  		 The data will be collected at baseline, and then subsequently at the end of 6, 12, 18 and 24 months. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
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)   01/05/2026 
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="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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Proposals should be directed to the principal investigator. To gain access, data requestors must sign a data access agreement, which will be cleared by the IEC of the All India Institute of Medical Sciences, Bathinda (Punjab), following which data can be shared.

  6. For how long will this data be available start date provided 01-06-2029 and end date provided 31-05-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Background: The burden of coronary artery disease, morbidity and mortality around the world is rapidly escalating and the burden is equivalently high in India. Recent research suggest that increasing air pollution is a significant factor for CAD. Due to agrarian backdrop, the rural environment is also impacted by anthropogenic, chemicals such as current use of pesticide and persistent organic pollutants. Literature review suggest a strong association between short and long-term ambient air pollution exposure and all cause cardiovascular mobility and mortality. However, the existing literature is primary restricted to depicting the association between exposure to selective air pollutants and incidence of CAD is over longer duration which is very resource intensive and non-feasible to replicate in absence of existing hot and historical environmental surveillance data. Patch evidence show that air pollution also exacerbate existing CAD, but this has not been reported in Indian population. that the aim will be to study the role of ambient and indoor pollution in two districts of Punjab towards worsening of clinical status among adults who have been recently diagnosed with coronary artery disease.
Methods: we will adopt a prospective study design over 18 months among eight locations of two districts of Punjab that differ from each other in terms of air, quality, population, size, industrialisation and traffic movements. We will include adults any is equal to 110 in each district with a known history of PAD in last year. We will collect patients health data at baseline and subsequently at the end of each partsix monthly. We will collect ambient air pollution data from each side every month and indoor air pollution data from each participant house for one month in each quarter. The primary dependent variable would be to would be the event that suggest worsening of CAD during the study period. It would be assessed during the history of chest pain, progression of heart failure, arrangement of biochemical, botanical profile, or a need for increased medica consultations or hospitalisation.
Expected outcomes, environmental data will be used to estimate the Hazard question, cumulative exposure and average annual exposure to develop linear or non-linear statistical models that explore the relationship between disease worsening due to exposure. Further the Cox proportional Hazard method will be deployed to observe in independent variables impact on patients outcome, which will also be graphically depicted using the Kaplan near survival curve. Metanalysis will be deployed to show the estimates from the two sides.

 
Close