| CTRI Number |
CTRI/2024/08/072646 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To compare the images taken by saline and contrast optical coherence tomography during coronary angioplasty |
|
Scientific Title of Study
|
Saline Vs Contrast Optical Coherence Tomography: A Prospective Multicenter Trial |
| 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 Ankush Gupta |
| Designation |
Professor of Medicine Interventional Cardiologist |
| Affiliation |
Army Institute of Cardio Thoracic Sciences |
| Address |
Department of Cardiology, Ground Floor, Room No.5, Golibar Maidan
Pune
MAHARASHTRA
411040
India |
| Phone |
9592903488 |
| Fax |
|
| Email |
drankushgupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankush Gupta |
| Designation |
Professor of Medicine Interventional Cardiologist |
| Affiliation |
Army Institute of Cardio Thoracic Sciences |
| Address |
Department of Cardiology, Ground Floor, Room No.5, Golibar Maidan
MAHARASHTRA
411040
India |
| Phone |
9592903488 |
| Fax |
|
| Email |
drankushgupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankush Gupta |
| Designation |
Professor of Medicine Interventional Cardiologist |
| Affiliation |
Army Institute of Cardio Thoracic Sciences |
| Address |
Department of Cardiology, Ground Floor, Room No.5, Golibar Maidan
MAHARASHTRA
411040
India |
| Phone |
9592903488 |
| Fax |
|
| Email |
drankushgupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Army Institute of Cardio Thoracic Sciences (AICTS) Department of Cardiology Golibar Maidan, Pune 411040 |
|
|
Primary Sponsor
|
| Name |
Principal Investigator |
| Address |
Army Institute of Cardio Thoracic Sciences (AICTS) Department of Cardiology Golibar Maidan Pune 411040 |
| Type of Sponsor |
Other [Self funding] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankush Gupta |
Army Institute of Cardio Thoracic Sciences |
Department of Cardiology, Ground Floor, Room No. 5, Golibar Maidan
Pune
MAHARASHTRA |
9592903488
drankushgupta@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Armed Forces Medical College e |
Approved |
| Postgraduate Institute of Medical Education and Research, Chandigarh Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I25||Chronic ischemic heart disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
OCT to be performed with Contrast and Saline |
Patients with IHD taken up for angiography. FD-OCT imaging will be done pre and post PCI in patients with significant coronary stenosis on Angiography. First Oct run shall be done with contrast followed by heparinized saline with catheter placed at same position. Repeat OCT shall be done with heparinized saline only. Pairs of OCT images shall be compared. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients are at least 18 years of age, undergoing OCT-guided PCI for acute or chronic coronary syndrome and willing to participate in this study will be enrolled |
|
| ExclusionCriteria |
| Details |
Patients having ST elevation myocardial infarction
Patients with end stage renal disease
Patients with significant Ostial left main disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pairs of OCT runs will be analysed at core lab by an expert investigator who is blinded to the identify of the runs. Three anatomically identical frames will be compared for measurements between saline and contrast run. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No secondary endpoint |
NIL |
|
|
Target Sample Size
|
Total Sample Size="688"
Sample Size from India="688"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/08/2024 |
| Date of Study Completion (India) |
02/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published in Journal of the American College of Cardiology, Advances, 20 March 2026 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This will be a Prospective, Multicentre Observational study at various centers across India. The present study is being conducted at multiple centres to do a head to head comparison of images and dimensions obtained during Contrast and Saline FD-OCT during per-cutaneous coronary intervention (PCI).Pairs of OCT runs will be analysed at core lab an expert investigator who is blinded to the identify of the of the runs. Three anatomically identical frames will be compared for measurements between saline and contrast run. Pre PCI pair of runs will be analysed and compared for luminal area (MLA), proximal reference diameter (PRD), distal reference diameter (DRD) and post PCI runs will be analysed for minimum stent area (MSA) and PRD/DRD at stent edges. To ensure that the quantitative analysis is done at the same anatomical point in both the heparinised saline and contrast runs, anatomical landmarks like side branch, macrophages, calcium thickness, cholesterol crystal and dissections will be identified during OCT analysis. PRD and DRD will be measured using the external elastic lamina wherever possible, otherwise luminal dimensions will be noted. Multiple markers will be used to confirm that the vessel dimensions were measured at the same anatomical position in both the runs regardless of the distance from the MLA as vessel length may vary considerably during the cardiac cycle. |