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CTRI Number  CTRI/2025/07/091345 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   A Study on Clinical Outcomes in Patients Undergoing Percutaneous Coronary Intervention (PCI): An Observational Registry with Retrospective and Prospective Data Collection 
Scientific Title of Study   The clinical outcomes in Patients who have undergone PCI intervention - Observational Registry with an ambispective Component  
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 Nagendra Boopathy S 
Designation  Professor of Cardiology  
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  B1 Room No 5 First Floor SMRC Block Sri Ramachandra Hospital 1 Ramachandra Nagar Porur Chennai 600116
B1 Room No 5 First Floor SMRC Block Sri Ramachandra Hospital 1 Ramachandra Nagar Porur Chennai 600116
Chennai
TAMIL NADU
600116
India 
Phone  9841330590  
Fax  0000  
Email  srmcclinicalresearch@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nagendra Boopathy S 
Designation  Professor of Cardiology  
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  B1 Room No 5 First Floor SMRC Block Sri Ramachandra Hospital 1 Ramachandra Nagar Porur Chennai 600116
B1 Room No 5 First Floor SMRC Block Sri Ramachandra Hospital 1 Ramachandra Nagar Porur Chennai 600116
Chennai
TAMIL NADU
600116
India 
Phone  9841330590  
Fax  0000  
Email  srmcclinicalresearch@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nagendra Boopathy S 
Designation  Professor of Cardiology  
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  B1 Room No 5 First Floor SMRC Block Sri Ramachandra Hospital 1 Ramachandra Nagar Porur Chennai 600116
B1 Room No 5 First Floor SMRC Block Sri Ramachandra Hospital 1 Ramachandra Nagar Porur Chennai 600116
Chennai
TAMIL NADU
600116
India 
Phone  9841330590  
Fax  0000  
Email  srmcclinicalresearch@gmail.com  
 
Source of Monetary or Material Support  
Dr Nagendra Boopathy S Professor of Cardiology B1 Room No 5 First Floor SMRC Block Sri Ramachandra Hospital 1 Ramachandra Nagar Porur Chennai 600116 
 
Primary Sponsor  
Name  Dr Nagendra Boopathy S 
Address  B1 ROOM NO 5 FIRST FLOOR SMRC Block SRI RAMACHANDRA HOSPITAL 1 RAMACHANDRA NAGAR PORUR CHENNAI 600116 
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 S Nagendra Boopathy  Sri Ramachandra Hospital   B1 ROOM NO 5 FIRST FLOOR SMRC Block SRI RAMACHANDRA HOSPITAL 1 RAMACHANDRA NAGAR PORUR CHENNAI 600116
Chennai
TAMIL NADU 
9841330590
0000
srmcclinicalresearch@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Ramachandra Institute of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M954||Acquired deformity of chest and rib,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  not applicable  Nil 
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Confirmed Patient who have undergone percutaneous coronary intervention 
 
ExclusionCriteria 
Details  The patient refuses to give informed consent in the prospective cohort. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Major Adverse Cardiac Events which in a composite event with death MI and repeat target vessel revascularization   Major Adverse Cardiac Events which in a composite event with death MI and repeat target vessel revascularization . 
 
Secondary Outcome  
Outcome  TimePoints 
Includes death and MI and repeat target vessel revascularization, stroke and Major Bleeding  1 YEAR 
 
Target Sample Size   Total Sample Size="156"
Sample Size from India="156" 
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)   01/08/2025 
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="1"
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 - NO
Brief Summary  
INTRODUCTION:
Coronary artery disease (CAD) is a condition characterized by the narrowing or blockage of the coronary arteries, which supply blood to the heart muscle. CAD is usually caused by atherosclerosis, a build-up of plaque made up of cholesterol, fat, and other substances in the artery walls. Such plaque restricts blood flow to the heart and can lead to chest pain and myocardial infarction. Percutaneous coronary intervention (PCI) is one of the mainstay revascularization modalities in acute and chronic coronary artery diseases. Advancements in technique and technology have greatly improved the overall outcomes of PCI. There is a great need to assess the impact of various variables on the outcomes of PCI. Primary percutaneous coronary intervention (PCI) remains the cornerstone in the treatment by reducing the death rate in patients with acute myocardial infraction. A procedure registry, as a clinical data registry, is the result of a systematic process of data gathering, analysis, and storage that provides information about certain diagnostic or therapeutic
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2
rocedures. Such registries could help in measuring the effectiveness and quality of care, as well as monitoring the safety of procedures. Indeed, the cardiac procedure registry in Australia(1) led to early identification of outlier performance to ensure the maintenance of cardiac care standards and benchmarking of outcome data with feedback to clinicians and hospitals. Similarly, the deployment of the National Cardiovascular Data Registry (NCDR) in the United States resulted in better monitoring of cardiac procedures, comparison of diagnostic and therapeutic patterns in different settings, and assessment of the safety and performance of medical equipment used for cardiac procedures. The development of a PCI registry in collecting data and maintaining the standard of care comparable to global needs . This registry could help improve PCI outcomes and minimize complications of the PCI procedure. Improving data collection and processing approaches is necessary to build this registry efficiently and effectively. We aim to create a PCI registry at SRIHER to collect data effectively and to utilize it for all research purposes.
VERSION 1.0 dated 26.7.2024
3
STUDY DESIGN:
ï‚· Type of Study: Observational registry with an ambispective component
ï‚· Study Population: All patients who have undergone PCI at SRIHER from October 2016 or who will undergo PCI in future.[Retrospective cohort and Prospective cohort]
METHODS:
ï‚· This is an investigator-initiated registry to be performed by Department of Cardiology, Sri Ramachandra Institute of Higher Education and Research (SRIHER), Porur, Chennai.
ï‚· We will be collecting details of patients who have undergone percutaneous coronary intervention from October 2016 and who will undergo PCI.
ï‚· Patients’ details will be identified from the Cardiac Catheterization register and also from the Hospital patient database.
ï‚· Deidentified data including baseline characteristics, angiographic, and interventional details will be collected for the population.
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Inclusion Criteria
 Age ≥ 18 years old.
ï‚· Confirmed Patient who have undergone percutaneous coronary intervention
Exclusion Criteria
The patient refuses to give informed consent in the prospective cohort.
OUTCOMES:
Primary Outcomes: Major Adverse Cardiac Events (MACE) which in a composite event with death, MI and repeat target vessel revascularization .
Secondary outcome: Includes death and MI and repeat target vessel revascularization, stroke and Major Bleeding ( BAR>3 )
ETHICAL CONSIDERATIONS:
ï‚· Obtain approval from the Institutional Ethics committee
ï‚· Register the registry in CTRI
 
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