| CTRI Number |
CTRI/2025/03/083712 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
29/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparing the clarity of heart scan images taken with low radiation and improved using two different techniques. |
|
Scientific Title of Study
|
Comparison of Image Quality in Low Dose , Low Contrast Computed Tomography Coronary Angiogram Reconstructed With Filtered Back Projection and Iterative Reconstruction Algorithm |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SACHIN DINAKARA NAIK |
| 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, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8762373273 |
| Fax |
|
| Email |
sachinnaik5258@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SACHIN DINAKARA NAIK |
| 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, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8762373273 |
| Fax |
|
| Email |
sachinnaik5258@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Sharath S |
| Designation |
Assistant Professor Senior Scale |
| Affiliation |
Maniapal College of Health Profession |
| Address |
Department of medical imaging technology,
Manipal college of health professions, Manipal academy of higher education, Manipal, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9483275486 |
| Fax |
|
| Email |
sharath.s@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Not Appilicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [NA] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prakashini K |
Kasturba Hospital |
Room No - 2, Department of Radiodiagnosis
Kasturba Hospital
Manipal 576104
Udupi
KARNATAKA |
9845053325
prakashini.k@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 - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I798||Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age range 18-80 Years
All sexes
All the patients referred for CT Coronary Angiography
Ability to sustain a Breath hold for minimum of 8-10 Sec
|
|
| ExclusionCriteria |
| Details |
Patient with high BMI
CABG Cases
Coronary Stents |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The significance of this research lies in its potential to improve the efficacy and safety of coronary computed tomography angiography (CCTA) By reducing radiation exposure and contrast agent use.
With a comparative analysis of different reconstruction techniques. This research aims to find the optimal reconstruction method to achieve high image quality in a low-dose protocol. This provides important insights for improving CT coronary angio.
|
12 months (February 2025-February 2026) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
Final Enrollment numbers achieved (Total)= "76"
Final Enrollment numbers achieved (India)="76" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/04/2025 |
| Date of Study Completion (India) |
31/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/03/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
· After all the approvals sample size screening will be executed with respect to inclusion and exclusion criteria. · All the procedure will be explained to the patient and breath bold instructions should be given and heart rate should be monitored. · All the demographic details will be collected. · Scan will perform using the standard operating protocol · The best cardiac phase with least motion artifact will be reconstructed with respect to R-R interval. · The best Phase will be selected and reconstructed using filtered back and iterative (idose level 3) reconstruction algorithm by keeping the filter CB constant · All the images will be then transferred to ISP server for image analysis. · Image will be analysed qualitatively and quantitively. For quantitative analysis ROI will be placed LM, RCA, LAD, LCX and Major branch to calculate CNR, SNR and image noise. · For qualitative analysis images will be accessed by two Radiologist without revealing the reconstruction technique to access image quality. |