| CTRI Number |
CTRI/2018/06/014608 [Registered on: 25/06/2018] Trial Registered Prospectively |
| Last Modified On: |
22/06/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparitive study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of age and gender on heart disease measured by ultrasound scanning test in patients undergoing angioplasty procedure |
|
Scientific Title of Study
|
Influence of age and gender on plaque morphology measured by Intravascular ultrasound (IVUS) in patients undergoing coronary intervention |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jothi sorubha |
| Designation |
Student |
| Affiliation |
SOAHS MAHE |
| Address |
Dept of CVT SOAHS MAHE MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9566934697 |
| Fax |
|
| Email |
jothialagar1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hashir Kareem |
| Designation |
Associate prof & Unit III head |
| Affiliation |
Karnataka medical council |
| Address |
Department of cardiovascular technology kasturba hospital manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
hashirkareem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jothi sorubha |
| Designation |
Student |
| Affiliation |
School of Allied Health Sciences |
| Address |
Department of cardiovascular technology SOAHS Manipal MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
jothialagar1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jothi sorubha School of Allied Health Sciences , Manipal |
|
|
Primary Sponsor
|
| Name |
jothi sorubha |
| Address |
Department of cardiovascualr technology , SOAHS , Manipal |
| 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 |
| Jothi sorubha |
Kasturba hospital |
Department of cardiology cathlab , Kasturba hospital , Manipal
Udupi
KARNATAKA |
9566934697
jothialagar1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college & hospital Institutional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing Angioplasty with IVUS guiding, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing Intravascular ultrasound guided oercutaneous coronary intervention |
|
| ExclusionCriteria |
| Details |
Instent restenosis
Coronary artery bypass graft lesion
Previous percutaneous coronary intervention
Chronic total occlusion |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| By understanding the plaque morphology in different age groups helps us in decision making treatment strategy |
2years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| By understanding the plaque morphology in different age groups helps us in decision making treatment strategy |
2years |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/06/2018 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim of the study: To assess the influence of age and gender on plaque morphology / characteristicsmeasured by intravascular ultrasound in patients undergoing percutaneous coronary intervention
Objectives: To compare the plaque morphology in terms of different age groups in male and female : <40yrs 40-60yrs >60yrs |