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CTRI Number  CTRI/2025/05/086246 [Registered on: 05/05/2025] Trial Registered Prospectively
Last Modified On: 02/05/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Longitudinal study 
Study Design  Single Arm Study 
Public Title of Study   Comparing blockages in the heart vessels and health outcomes due to them in patients with chronic kidney disease and those with normal kidney function 
Scientific Title of Study   Patterns and Outcomes of Coronary Artery Disease in Chronic Kidney Disease: Comparative Prospective Observational 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 Ravindra Prabhu A 
Designation  Professor and Unit Head 
Affiliation  Kasturba Medical College, MAHE, Manipal 
Address  Room no. 15, Department of Nephrology, OPD Block, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448107771  
Fax    
Email  ravindra.prabhu@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Ganesh Paramasivam  
Designation  Additional Professor  
Affiliation  Kasturba Medical College, MAHE, Manipal 
Address  Department of Cardiology, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9914204224  
Fax    
Email  ganesh.p@manipal.edu   
 
Details of Contact Person
Public Query  
Name  Dr Ravindra Prabhu A 
Designation  Professor and Unit Head 
Affiliation  Kasturba Medical College, MAHE, Manipal 
Address  Room no. 15, Department of Nephrology, OPD Block, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448107771  
Fax    
Email  ravindra.prabhu@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India 576104 
 
Primary Sponsor  
Name  Not Applicable 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 Ganesh Paramasivam  Kasturba Medical College, Manipal  Department of Cardiology, 3rd Floor, OPD Block, Kasturba Medical College, Manipal
Udupi
KARNATAKA 		 9914204224

ganesh.p@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N18||Chronic kidney disease (CKD), (2) ICD-10 Condition: I20-I25||Ischemic heart diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients undergoing Coronary Angiogram for the first time at the KMC hospital. 
 
ExclusionCriteria 
Details  Participants who decline participation; having incomplete medical records or missing essential data, are pregnant, have a documented history of prior CAG, PCI, or coronary artery bypass grafting (CABG), have severe valvular heart disease, or have a critical illness with a life expectancy of less than one year will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the anatomy and morphology of coronary artery lesions in CKD and compare these with non-CKD patients.  24 months 
 
Secondary Outcome  
Outcome  TimePoints 
prevalence of CAD among CKD patients undergoing CAG and
compare it with non-CKD group with similar indications. 		 24 months 
cardiovascular outcomes (3P-MACE), (4P-MACE), and (5P-MACE)  24 months 
Comparison of (3P-MACE), (4P-MACE), (5P-MACE), Mortality, Progression of CKD among CKD patients with and without comorbidities  24 months 
 
Target Sample Size   Total Sample Size="900"
Sample Size from India="900" 
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)   01/06/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 aims to delve into the trends of lesions in the coronary artery and clinical outcomes in patients with CAD, both with and without CKD, who are undergoing CAG prospectively. The main emphasis will be on assessing the anatomy, quantity, and types of lesions in CAD patients with CKD compared to those with normal kidney function. Additionally, the prevalence of CAD in CKD patients undergoing CAG will be contrasted with the non-CKD cohort, followed by evaluating the CV outcomes such as 3-point Major Adverse Cardiac Events (3P-MACE) that include CV death, nonfatal MI, nonfatal stroke, 4P-MACE (additionally including unstable angina), 5P-MACE (further inclusion of hospitalization for heart failure (HHF), Mortality, and progression of CKD in these patient demographics, offering an understanding of comparative risks and the necessity for specific management strategies in CKD populations. Finally, a subgroup analysis will be done by comparing the above outcomes among CKD patients with and without comorbidities.

 
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