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CTRI Number  CTRI/2025/08/092242 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 02/08/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   A Study to Establish a Genetic Registry for the Cardiovascular Diseases in The Asian Population  
Scientific Title of Study   A Study to Establish a Genetic Registry for the Cardiovascular Diseases in The Asian Population  
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 Daljeet Kaur Saggu 
Designation  MBBS MD DM Consultant Cardiologist Electrophysiologist 
Affiliation  Asian Institute Of Gastroenterology 
Address  Room No 05 Cardiology Department Near Device Clinic Area 4/5 Plot Tower-2 Mindspace Rd P Janardhan Reddy Nagar Gachibowli Hyderabad

Hyderabad
TELANGANA
500032
India 
Phone  8978428938  
Fax    
Email  drdaljeetsaggu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Daljeet Kaur Saggu 
Designation  MBBS MD DM Consultant Cardiologist Electrophysiologist 
Affiliation  Asian Institute Of Gastroenterology 
Address  Room No 05 Cardiology Department Near Device Clinic Area 4/5 Plot Tower-2 Mindspace Rd P Janardhan Reddy Nagar Gachibowli Hyderabad

Hyderabad
TELANGANA
500032
India 
Phone  8978428938  
Fax    
Email  drdaljeetsaggu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Radhika Korabathina 
Designation  Clinical Research Coordinator 
Affiliation  Asian Institute Of Gastroenterology 
Address  Tilt Room Cardiology Department near Device Clinic Area 4/5 Plot Tower-2 Mindspace Rd P Janardhan Reddy Nagar Gachibowli Hyderabad

Hyderabad
TELANGANA
500032
India 
Phone  9989918587  
Fax    
Email  epresearch@yahoo.com  
 
Source of Monetary or Material Support  
Asian Institute of Gastroenterology, Mind Space Road,Gachibowli, Hyderabad, Telangana,India-500032 
 
Primary Sponsor  
Name  Asian Institute of Gastroenterology 
Address  4/5 plot Tower-2 Mindspace Rd P Janardhan Reddy Nagar Gachibowli Hyderabad Telangana  
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 Daljeet Kaur Saggu  Asian Institute Of Gastroenterology (AIG)  4/5 Plot Tower-2 Mindspace Rd P Janardhan Reddy Nagar Gachibowli Hyderabad
Hyderabad
TELANGANA 		 8978428938

drdaljeetsaggu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Asian Institute Of Gastroenterology(IEC-AIG)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I499||Cardiac arrhythmia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All Patients with gene Positive Cardiovascular Disease

Gene Positive first degree relative of index patient with GCVD 
 
ExclusionCriteria 
Details  Patients not giving Consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Evaluate the clinical Characteristics of the Patient diagnosed with GCVD  1 t0 5 years 
 
Secondary Outcome  
Outcome  TimePoints 
To Collect data on frequency of different Genes in patients with GCVD in an Asian Subcontinent  1 to 5 years 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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)   25/08/2025 
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="5"
Months="0"
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 - All of the individual participant data collected during the trial, after de-identification.

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

  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 - Proposals should be directed to [drdaljeetsaggu@gmail.com].

  6. For how long will this data be available start date provided 25-08-2025 and end date provided 25-08-2030?
    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  

Title: Asian Genetic Registry for Cardiovascular Diseases (AGRC)

Study Type: Prospective Observational Study (Registry)

 Background:

Cardiovascular diseases (CVDs) are the leading cause of morbidity and mortality globally, with genetic factors playing a significant role in disease susceptibility, progression, and response to treatment. South Asian populations are disproportionately affected by CVDs and remain underrepresented in global genetic studies.

 Objective:

To establish a comprehensive genetic and clinical data repository of individuals with cardiovascular diseases across Asia, focusing on identifying genetic variants and risk profiles unique to Asian populations.

 Primary Aim:

To study genetic markers associated with various forms of cardiovascular diseases such as cardiomyopathies, coronary artery disease, arrhythmias, and congenital heart defects in the South Asian population.

 Methodology:

 This is a prospective, multicentre, observational registry.

 Participants will be enrolled from hospitals and cardiology clinics across India (and other Asian countries, if applicable).

 Data collected will include demographic details, clinical history, diagnostic test results, ECG, echocardiography, family history, and biological samples (e.g., blood) for genetic analysis.

 No interventions or randomization involved.

 Data will be anonymized and stored for future research related to cardiovascular genetics.

 Target Sample Size: 1000 (or as per your actual protocol)

 Study Duration: 5 years

 Ethical Considerations:

The study will follow ICMR and GCP guidelines. Ethics Committee approval will be obtained at each participating site. Informed consent will be taken from all participants prior to data and sample collection. 
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