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CTRI Number  CTRI/2018/01/011150 [Registered on: 04/01/2018] Trial Registered Prospectively
Last Modified On: 11/11/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Morphological and Functional Characterization of Plaques in Young Indian Acute Coronary Syndrome Patients by Optical Coherence Tomography and Fractional Flow Reserve  
Scientific Title of Study   A prospective, multi-centric study to investigate the plaque characteristics and natural history of lesions in the non-culprit vessels in young Indian patients (less than 45 yrs) with ACS undergoing PCI by Optical Coherence Tomography (OCT) imaging 
Trial Acronym  ACS-OCT  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Upendra Kaul 
Designation  Chairman 
Affiliation  Batra Hospital & Medical Research Centre 
Address  Batra Heart Centre, 1, Tughlakabad Institutional Area, Mehrauli Badarpur road, New Delhi

New Delhi
DELHI
110062
India 
Phone  9811150518  
Fax  01129957661  
Email  kaul.upendra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Upendra Kaul 
Designation  Chairman 
Affiliation  Batra Hospital & Medical Research Centre 
Address  Batra Heart Centre, 1, Tughlakabad Institutional Area, Mehrauli Badarpur road, New Delhi

New Delhi
DELHI
110062
India 
Phone  9811150518  
Fax  01129957661  
Email  kaul.upendra@gmail.com  
 
Details of Contact Person
Public Query  
Name  Yumnam Diana Devi 
Designation  Assistant Manager  
Affiliation  Batra Hospital & Medical Research Centre 
Address  Academics and Research Department, 1st floor, Batra Heart Centre,1, Tughlakabad Institutional Area, Mehrauli Badarpur road, New Delhi

New Delhi
DELHI
110062
India 
Phone  9654341135  
Fax  01129957661  
Email  yumnam.diana@batrahospitaldelhi.org  
 
Source of Monetary or Material Support  
Batra Hospital and Medical Research Centre, 1, Tughlakabad Institutional Area, Mehrauli Badarpur Road, New Delhi-110062 
 
Primary Sponsor  
Name  Batra Hospital and Medical Research Centre 
Address  1, Tughlakabad, Institutional Area, Mehrauli Badarpur, Road, New Delhi-110062 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Abott Vascular  #665/10,11-B Main Road, 5th Block, Jayanager Bangalore 560041 India.  
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr D K Baruah  Apollo Hospitals  Chinnagadilli Arilova Visakhapatnam Andhra Pradesh 530040
Visakhapatnam
ANDHRA PRADESH 		 9848051710

baruahdk_9@yahoo.com 
Dr Upendra Kaul  Batra Heart Centre,Batra Hospital and Medical Research Centre  1, Tughlakabad Institutional Area, Mehrauli Badarpur road, New Delhi
New Delhi
DELHI 		 9811150518
01129957661
kaul.upendra@gmail.com 
Dr Sanjeeb Roy  Fortis Escorts Hospital  J L N Marg, Malviya Nagar
Jaipur
RAJASTHAN 		 9829644459

sanjeeb.roy@fortishealthcare.com 
Dr Rishi Sethi  King Georges Medical University  Department of Cardiology, Lucknow-226003
Lucknow
UTTAR PRADESH 		 9415085717

drrishisethi1@gmail.com 
Dr Nagendra Singh Chouhan  Medanta The Medicity  Sector 38 Gurgaon Haryana 122001
Gurgaon
HARYANA 		 9971382999

nagendra.chouhan@medanta.org 
Dr Rajesh Vijayvergia  Postgraduate Institute of Medical Education and Research  Madhya Marg, Sector 12-160012
Chandigarh
CHANDIGARH 		 9815221856

rajeshvijay999@hotmail.com 
Dr P K Goel  Sanjay Gandhi Post Graduate Institute of Medical Sciences  Raebareli Road Lucknow 226014
Lucknow
UTTAR PRADESH 		 9839015010

golf_pgi@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Institutional Ethics Committee, Fortis Escorts Hospital, Jaipur  Approved 
Institutional Ethics Committee, king Georges Medical university, U.P.  Approved 
Institutional Ethics Committee, PGIMER, Chandigarh  Approved 
Institutional Ethics Committee, SGPGI Lucknow  Approved 
Institutional Ethics Committee,Apollo Hospital, Vishakhapatnam  Approved 
Medanta Institutional Ethics Committee  Approved 
Scientific Research and Ethical Review Committee, Batra Hospital and Medical Research Centre, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I248||Other forms of acute ischemic heart disease, young indian acute coronary syndrome patients who are less than 45 years of age,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Patient is more than or equals to 18 and less than or equals to 45 years of age and going for PCI of the culprit lesion (more than 90 per cent diameter stenosis)

At least more than or equals to 1 de novo lesions in a native coronary segment with a visually estimated diameter stenosis between more than or equals to 40 per cent and less than 90 per cent

Patient has documented ACS ( unstable angina, NSTEMI or STEMI within the previous 72 hours)

Patient demonstrates a left ventricular ejection fraction (LVEF) of more than or equals to 40 per cent as measured prior to enrollment

Patient understands and agrees to comply with all specified study requirements and provides written Informed Consent to this effect

 
 
ExclusionCriteria 
Details  The patient has a life expectancy of less than 24 months due to another medical condition

Patient exhibits cardiogenic shock (systolic pressure less than 80mm Hg and PCWP more than 20mm Hg or cardiac index less than 1.8 liters per minute per meter square or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure more than 80 mm Hg) for any time within 24 hours prior to index procedure.

Patient demonstrates evidence of acute or chronic renal dysfunction (serum creatinine more than 2.0 mg per dl or 177 μmol per l)

Planned cardiac surgery procedure less than or equals to 6 months post-index procedure.

Cerebrovascular accident (CVA) including stroke or TIA within previous 3 months

Patient has contraindication to Aspirin clopidogrel, prasugrel or ticagrelor

Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 6 months post index procedure

Patient that in the opinion of the investigator is not clinically appropriate for OCT evaluation

Patient in whom the primary culprit lesion requiring PCI have one of the following characteristics –
vessel is moderately or severely calcified, by visual estimate
lesion is ostial in location (within 5.0 mm of vessel origin)
lesion involving arterial segments with highly tortuous anatomy or where lesion is located within or distal to a more than 60 degree bend in the vessel.
lesion involves a diseased (more than 50 per cent stenotic) side branch more than 2.0 mm in diameter
lesion is located in the left main coronary artery, whether protected or unprotected
arterial or saphenous vein graft lesions or lesions distal to a diseased arterial or saphenous vein graft
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
minimum lumen area, fibrous cap thickness, lipid arc extension, presence of micro-calcification macrophage infiltration and microchannel formation at the explored plaques, spotty calcification and cholesterol crystals
plaque disruption
Intraluminal abnormalities: Red thrombus, White thrombus, Re-canalized thrombus
In the group of stented patients additionally we will look for features of stent mal-apposition, NIH, plaque prolapse and intimal dissection

 		 baseline and 1 year  
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of MACE, a composite of Cardiac Death, MI or re-hospitalization for progressive angina  30 days, 6, months and 1, 2 and 3 years  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/01/2018 
Date of Study Completion (India) 11/03/2022 
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)  		 Indian heart Journal https://doi.org/10.1016/j.ihj.2024.11.001 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Coronary artery disease and its manifestations are seen at younger ages, presentation with acute coronary syndromes and with high fatality in Indian patients. Recent investigations have implicated a complex interaction of certain phenotypic characterization of plaque detected on coronary CTA and risk factors for a pro-thrombotic milieu as an important substrate associated with a higher risk of ACS. Lipid rich plaques as seen by OCT evaluation in non-culprit vessels have been reported to be predictors of adverse outcomes. Additional FFR evaluation also can predict higher event rates in patients with abnormal FFR values. There is no published data among CAD patients in India which characterizes coronary plaque morphology and plaque burden with OCT in non- culprit vessels in predicting future events like ACS in young Indian patients undergoing PCI for symptomatic CAD.

Our hypothesis is that young ACS patients with TCFA in non-culprit vessels will have a worse outcome as compared to those without TCFA. In addition, lesions in non-culprit vessels with FFR < 0.80 would be an additional predictor of adverse outcomes during follow up.

Optical coherence tomography (OCT) is emerging as a new gold standard for endovascular imaging of plaque morphology especially identifying vulnerable plaques. The addition of FFR evaluation in these vessels could give incremental information in predicting adverse morbid events like ACS and sudden death on follow up. 

The ACS-OCT India will evaluate the plaque characteristics (minimum lumen area, fibrous cap thickness, lipid arc extension, presence of microcalcification macrophages infiltration and microchannel formation at the explored plaques) of non-culprit lesions at baseline & follow-up by OCT analysis and additional FFR. This information will be correlated with the follow clinical data in these patients undergoing PCI for ACS in young Indian patients.

 
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