| CTRI Number |
CTRI/2019/05/019344 [Registered on: 24/05/2019] Trial Registered Prospectively |
| Last Modified On: |
17/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Does the location and length of blockage in arteries of heart matter |
|
Scientific Title of Study
|
Impact of location and length of intermediate coronary stenosis on its physiological significance using fractional flow reserve and its correlation with intravascular ultrasound. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JEET RAM KASHYAP |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Government Medical College & Hospital, Sector-32, Chandigarh, INDIA |
| Address |
DEPARTMENT OF CARDIOLOGY GOVERNMENT MEDICAL COLLEGE CHANDIGARH
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646461971 |
| Fax |
|
| Email |
jeetramkashyap@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
JEET RAM KASHYAP |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Government Medical College & Hospital, Sector-32, Chandigarh, INDIA |
| Address |
DEPARTMENT OF CARDIOLOGY GMCH 32 CHANDIGARH
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646461971 |
| Fax |
|
| Email |
jeetramkashyap@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
JEET RAM KASHYAP |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Government Medical College & Hospital, Sector-32, Chandigarh, INDIA |
| Address |
DEPARTMENT OF CARDIOLOGY GMCH 32 CHANDIGARH
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646461971 |
| Fax |
|
| Email |
jeetramkashyap@yahoo.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT MEDICAL COLLEGE & HOSPITAL SECTOR 32 B CHANDIGARH INDIA |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT MEDICAL COLLEGE HOSPITAL CHANDIGARH |
| Address |
SECTOR 32 B CHANDIGARH INDIA |
| Type of Sponsor |
Government medical college |
|
|
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 JEET RAM KASHYAP |
DEPARTMENT OF CARDIOLOGY GOVERNMENT MEDICAL COLLEGE & HOSPITAL CHANDIGARH |
Room No 538 Block D Level 5 GMCH SECTOR 32 B CHANDIGARH
Chandigarh
CHANDIGARH |
09646461971
jeetramkashyap@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT MEDICAL COLLEGE & HOSPITAL SECTOR 32 CHANDIGARH INDIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I208||Other forms of angina pectoris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
-- |
-- |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
ALL PATIENTS AGED MORE THAN 18 YEARS WITH STABLE ANGINA WILLING TO PARTICIPATE IN THE STUDY AND HAVING INDICATIONS FOR CORONARY ANGIOGRAPHY AND HAVING INTERMEDIATE CORONARY STENOSIS ON ANGIOGRAPHY e.i. 40 - 80% SHALL BE INCLUDED IN THE STUDY FOR FUTHER EVALUATION OF THESE LESIONS BY USING FRACTIONAL FLOW RESERVE FFR TO KNOW THEIR PHYSIOLOGICAL SIGNIFICANCE AND INTRAVASCULAR ULTRASOUND SHALL ALSO BE DONE TO KNOW THE PLAQUE MORPHOLOGY AND COMPOSITION TO FINF THE CORRELATION BETWEEN FFR AND IVUS AS WELL AS QCA. |
|
| ExclusionCriteria |
| Details |
1. Acute coronary syndrome (STEMI/NSTEMI/UA)
2. Culprit lesion of previous myocardial infarction
3. Previous coronary artery bypass surgery
4. Tandem lesion
5. In-stent restenosis lesion
6. Cardiogenic shock
7. Low left ventricular systolic function (LVEF < 40%)
8. Chronic Kidney Disease
9. Chronic Liver Disease
10. Pregnant females
11. Failure to obtain informed consent from participants
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CORRELATION BETWEEN LOCATION AND LENGTH OF LESION ON ITS PHYSIOLOGICAL SIGNIFICANCE BY USING FRACTIONAL FLOW RESERVE (FFR) |
At 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine the correlation between QCA, IVUS and FFR for intermediate coronary lesions.
2. To find a correlation between FFR and BARI scores used for assessment of myocardial area under jeopardy
|
CROSS SECTIONAL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/06/2019 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NOT YET STARTED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
THIS STUDY SHALL BE CONDUCTED AT A SINGLE CENTRE IN NORTHERN PART OF INDIA e.i. GOVERNMENT MEDICAL COLLEGE & HOSPITAL SECTOR 32 CHANDIGARH IN PATIENTS WITH CHRONIC STABLE ANGINA AGED MORE THAN 18 YEARS AND HAVING INDICATIONS FOR CORONARY ANGIOGRAPHY AFTER OBTAINING INFORMED CONSENT. THOSE PATIENT WHO SRE FOUND TO HAVE INTERMEDIATE CORONARY LESION SHALL FURTHER BE SUBJECTED TO FRACTIONAL FLOW RESERVE AND INTRAVASCULAR ULTRASOUND AND QCA ANALYSIS AND BARI SCORE EVALUATION. THE TRIAL PROTOCOL HAS BEEN ALREADY EVALUATED AND APPROVED BY THE RESEARCH COMMITTEE OF THE INSTITUTE AND HAS FURTHER BEEN SUBMITTED TO INSTITUTIONAL ETHICS COMMITTEE FOR FINAL APPROVAL. THE APPROVAL OF ETHICS COMMITTEE IS AVAITED VERY SOON AND THE DAY WE GET THE APPROVAL THE STUDY SHALL BE STATRED IMMEDIATELY. |