| CTRI Number |
CTRI/2010/091/000439 [Registered on: 17/09/2010] |
| Last Modified On: |
|
| Post Graduate Thesis |
|
| Type of Trial |
|
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Type of Study
|
|
| Study Design |
Other |
|
Public Title of Study
|
Assessment of aortic valve disease by CT imaging |
|
Scientific Title of Study
|
Assessment of aortic valve disease by CT imaging |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alpa Bharati |
| Designation |
|
| Affiliation |
|
| Address |
Asian Heart Institute and Research Center, CT Scan Department
Bandra Kurla Complex, Bandra East
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02266986666 |
| Fax |
|
| Email |
alpabharati@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Alpa Bharati |
| Designation |
|
| Affiliation |
|
| Address |
Asian Heart Institute and Research Center, CT Scan Department
Bandra Kurla Complex, Bandra East
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02266986666 |
| Fax |
|
| Email |
alpabharati@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Alpa Bharati |
| Designation |
|
| Affiliation |
|
| Address |
Asian Heart Institute and Research Center, CT Scan Department
Bandra Kurla Complex, Bandra East
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02266986666 |
| Fax |
|
| Email |
alpabharati@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JB Chemicals Pvt Ltd., 4th Floor, B-wing, Neelam Centre, behind cycle road, worli, Mumbai 400030 |
| Address |
|
| Type of Sponsor |
|
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Alpa Bharati |
CT Scan Department |
Asian Heart Institute, Bandra Kurla Complex,Bandra East-400052
Mumbai
MAHARASHTRA |
02266986666
alpa.bharati@ahirc.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Asian Heart Institute and Research Centre |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Aortic valvular diseases, mainly stenosis and regurgitation due to atherosclerotic disease, rheumatic heart disease or congenital heart disease, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
multidetector CT imaging |
64 slice MDCT imaging using routine coronary imaging protocol |
| Comparator Agent |
transthoracic echocardiography |
transthoracic echocardiography done either 2 months before or after CT study |
|
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Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
adults (>14years of age) with known or suspected aortic valvular dis aortic valvular disease due to either atherosclerotic, congenital or infective pathology
|
|
| ExclusionCriteria |
| Details |
pediatric age group of 0 to 14years
Known allergy to contrast media, high sr. creatine levels, patients with significantly poor cardiac function in whom ECG gating with beta-blockers or SA node inhibitors is not advisable. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| obtaining aortic valve area by MDCT |
after CT imaging of the enitre study group comparison with 2D echo will be done. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
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Target Sample Size
|
Total Sample Size="50"
Sample Size from India=""
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)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/11/2010 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
|
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
this is a prospective, single centre study to evlauate role of multidetector CT imaging in assessment of aortic valvular disease and its correlation with transesophageal echocardiography and wether it can be considered a suitable option for those patients in whom echocardiography is difficult and to assess if any additional relevant data besides coronary arterial disease can be obtained through CT imaging |