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CTRI Number  CTRI/2022/09/045872 [Registered on: 26/09/2022] Trial Registered Prospectively
Last Modified On: 14/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Correlation of Cardiac Function on Aortic Enhancement in Coronary Angiography. 
Scientific Title of Study   Correlation between Cardiac Function on Aortic Enhancement in ECG Gated Coronary Angiography. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Clireen Paes 
Designation  Post Graduate Student 
Affiliation  Manipal College of Health Professions 
Address  Department of Medical Imaging Technology. Manipal College of Health Professions. Manipal Academy of Higher Education,Manipal,Karnataka-576104

Udupi
KARNATAKA
576104
India 
Phone  8861651928  
Fax    
Email  clireen.paes@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Visakh T  
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Medical Imaging Technology. Manipal College of Health Professions. Manipal Academy of Higher Education,Manipal,Karnataka-576104

Udupi
KARNATAKA
576104
India 
Phone  8281182310  
Fax    
Email  visakh.t@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Clireen Paes 
Designation  Post Graduate Student 
Affiliation  Manipal College of Health Professions 
Address  Department of Medical Imaging Technology. Manipal College of Health Professions. Manipal Academy of Higher Education,Manipal,Karnataka-576104

Udupi
KARNATAKA
576104
India 
Phone  8861651928  
Fax    
Email  clireen.paes@learner.manipal.edu  
 
Source of Monetary or Material Support  
Room Number2 Department of Radiodiagnosis and Imaging. Emergency Trauma Block.Katurba Hospital Manipal. Karnataka 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [] 
 
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 
Clireen Paes  Kasturba Medical College  Department of Radio diagnosis and Imaging. Philips Incisive 128 Slice CT.
Udupi
KARNATAKA 		 8861651928

clireen.paes@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I779||Disorder of arteries and arterioles, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1)Subjects undergoing CT Coronary Angiography.
2)Age range between 18 years to 80 years.
3)Both sexes 
 
ExclusionCriteria 
Details  Subjects who have undergone CABG, Subjects who are allergic to Contrast Media, Subjects with Aortic regurgitation, Subjects with outflow tract obstruction, Subjects having high calcification in the aortic vessel. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Cardiac output: measured in L/min
2. Ejection Fraction: in percentage %
3. Stroke volume: ml
4. Heart rate: beats per minute
5. Aortic Peak enhancement: HU  		 From: January 2022 To: March 2023
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  nil 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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)   03/10/2022 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
  • Approval will be acquired from Institutional Research Committee, MCHP & Institutional Ethics Committee, and Kasturba Hospital Manipal for conducting the research. 
  • CTRI registration will be done. 
  •  Subjects who are undergoing CT coronary angiography will be selected for the study based on Inclusion and exclusion criteria. 
  •  Informed consent will be taken from the patient 
  • All the scans will be performed using Standard ECG gated coronary angiography CT Protocol of the Department. 
  •  All the ECG gated coronary angiography are done on Philips 128 slice incisive CT scanner.
  • The patient’s file will be used to acquire patient information such as age, gender, weight, and height. 
  •  For the scan, the patient is positioned supine - feet first orientation and centered for Cardiac scan by placing vertical laser on the midsagittal plane and horizontal laser on mid coronal of the thorax. 
  •  180 anterior to posterior scanogram in craniocaudal will be obtained from the apex of the lungs to the costophernic angle. 
  • A plain scan will be taken in the craniocaudal direction and the technologist will examine the image for any motion artefact after which a locator will be placed on the carina. 
  •  The locator is placed on the carina where the pulmonary trunk divides into the right and left Pulmonary artery. Bolus tracking is used with the ROI positioned at the descending aorta and the threshold will be kept at 120 HU. 
  •  80ml on contrast with 40ml of saline at a flow rate of 5cc/sec is injected. 
  •  After evaluation of the image, the patient is taken off the positioning table and the cardiac phases are reconstructed with respect to R-R interval. 
  • The following are the cardiac-specific parameters: Heart rate, left ventricular volume, ejection fraction, cardiac output.
  •  These images will be collected from the ISP server (version10).
  • The images are obtained from the main cardiac phase is 75% from there the cardiac phases are reconstructed from phase 10% to phase 90% with respect to the R-R interval. The reconstructed phases are uploaded to the Cardiac comp. 
  •  The cardiac comp has a function option that will provide us with stroke volume, ejection fraction, and cardiac output values in the form of a table.

 
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