| CTRI Number |
CTRI/2025/09/094416 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
06/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Studying Heart Artery Blockages with Advanced CT Scans in Patients Having Chest Pain in Rural Central India |
|
Scientific Title of Study
|
CORONARY PLAQUE CHARACTERIZATION USING 128-SLICE CT ANGIOGRAPHY IN SYMPTOMATIC PATIENTS FROM RURAL CENTRAL INDIA |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MUSKAN YADAV |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE ACHARYA VINOBA BHAVE RURAL HOSPITAL SAWANGI MEGHE WARDHA |
| Address |
S-24, RADHIKABAI HOSTEL,JAWAHARLAL NEHRU MEDICAL COLLEGE ACHARYA VINOBA BHAVE RURAL HOSPITAL SAWANGI MEGHE WARDHA
Wardha
MAHARASHTRA
442007
India |
| Phone |
9971062004 |
| Fax |
|
| Email |
muskaanyadav12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SHIVALI KASHIKAR |
| Designation |
PROFESSOR |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE ACHARYA VINOBA BHAVE RURAL HOSPITAL SAWANGI MEGHE WARDHA |
| Address |
HOUSE NO-121 BEHIND MAGANWADI RAMNAGAR WARDHA MAHARASHTRA
Wardha
MAHARASHTRA
442007
India |
| Phone |
9822471380 |
| Fax |
|
| Email |
Shivalikashikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHIVALI KASHIKAR |
| Designation |
PROFESSOR |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE ACHARYA VINOBA BHAVE RURAL HOSPITAL SAWANGI MEGHE WARDHA |
| Address |
HOUSE NO-121 BEHIND MAGANWADI RAMNAGAR WARDHA MAHARASHTRA
Wardha
MAHARASHTRA
442007
India |
| Phone |
9822471380 |
| Fax |
|
| Email |
Shivalikashikar@gmail.com |
|
|
Source of Monetary or Material Support
|
| JAWAHARLAL NEHRU MEDICAL COLLEGE ACHARYA VINOBA BHAVE RURAL HOSPITAL SAWANGI MEGHE WARDHA |
|
|
Primary Sponsor
|
| Name |
MUSKAN YADAV |
| Address |
JAWAHARLAL NEHRU MEDICAL COLLEGE SAWANGI MEGHE WARDHA |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| MUSKAN YADAV |
JAWAHARLAL NEHRU MEDICAL COLLEGE ACHARYA VINOBA BHAVE RURAL HOSPITAL SAWANGI MEGHE WARDHA |
DEPARTMENT OF RADIODIAGNOSIS CT REPORTING AND CONSOLE ROOM JNMC CAMPUS SAWANGI WARDHA
Wardha
MAHARASHTRA |
9971062004
muskaanyadav12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with chest pain, dyspnoea, palpitations, syncope, fatigue, reduced exercise tolerance, or a positive family history of CVD, referred for CCTA with suspected CAD, will be included
Patients providing written informed consent
Stable heart rate |
|
| ExclusionCriteria |
| Details |
Known hypersensitivity to iodinated contrast agents
Renal impairment
Uncontrolled arrhythmias or very high heart rates
Pregnancy
Poor image quality due to motion artifacts |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the prevalence and morphological characteristics of coronary plaques (calcified, non-calcified, and mixed) using 128-slice coronary CTangiography (CCTA) in symptomatic patients from rural Central India.
To assess the degree of coronary artery stenosis associated with different types of coronary plaques.
To explore correlations between coronary plaque characteristics and clinical risk
factors such as hypertension, diabetes, dyslipidaemia, smoking, and family
history. |
To evaluate the prevalence and morphological characteristics of coronary plaques (calcified, non-calcified, and mixed) using 128-slice coronary CT angiography (CCTA) in symptomatic patients from rural Central India.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/09/2025 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 2-year prospective observational cross-sectional study will evaluate symptomatic patients with suspected coronary artery disease using 128-slice coronary CT angiography. Plaques will be classified as calcified, non-calcified, or mixed, and stenosis severity graded. Associations between plaque types and clinical risk factors such as hypertension, diabetes, dyslipidemia, smoking, and family history will be assessed. The study aims to enhance non-invasive CAD diagnosis, identify high-risk plaques, and provide regional data for targeted prevention and management strategies. |