| CTRI Number |
CTRI/2018/05/013559 [Registered on: 01/05/2018] Trial Registered Prospectively |
| Last Modified On: |
28/04/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparing the strain on heart by using ultrasound scanning among long standing chest pain patients with and without heart block |
|
Scientific Title of Study
|
Comparison of LV deformation by echocardiography with and without CAD among chronic stable angina patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manjoosha |
| Designation |
MSc.Echocardiography |
| Affiliation |
School of Allied Health Sciences, Manipal |
| Address |
D/O P.Damodar
Near bhajana mandir, Moodukudru kallianpur post
Udupi Dist. Pin-576114
Near bhajana mandir, Moodukudru kallianpur post
Udupi Dist. Pin-576114
Udupi
KARNATAKA
576114
India |
| Phone |
9164513982 |
| Fax |
|
| Email |
manjoosha711ds@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manjoosha |
| Designation |
MSc.Echocardiography |
| Affiliation |
School of Allied Health Sciences, Manipal |
| Address |
D/O P.Damodar
Near bhajana mandir, Moodukudru kallianpur post
Udupi Dist. Pin-576114
Near bhajana mandir, Moodukudru kallianpur post
Udupi Dist. Pin-576114
Udupi
KARNATAKA
576114
India |
| Phone |
9164513982 |
| Fax |
|
| Email |
manjoosha711ds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manjoosha |
| Designation |
MSc.Echocardiography |
| Affiliation |
School of Allied Health Sciences, Manipal |
| Address |
D/O P.Damodar
Near bhajana mandir, Moodukudru kallianpur post
Udupi Dist. Pin-576114
Udupi
KARNATAKA
576114
India |
| Phone |
9164513982 |
| Fax |
|
| Email |
manjoosha711ds@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Cardiology Kasturba Medical college & hospital Manipal |
|
|
Primary Sponsor
|
| Name |
Department of Cardiology |
| Address |
Kasturba Medical College & Hospital ,MAHE,Manipal |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Manjoosha |
Department of Cardiology |
Room No:34
3rd floor, OPD block
Kasturba Hospital, Manipal
Udupi
KARNATAKA |
9164513982
manjoosha711ds@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Kasturba hospital, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Stable angina patients with positive Treadmill Test, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Chronic stable angina patients with positive treadmill Test |
|
| ExclusionCriteria |
| Details |
1. Valvular Heart disease
2. Old MI
3. Post CABG angina |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing ventricular deformation of patients with and without coronary artery disease having positive treadmill test by using echocardiography |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| it gives more awareness to the group of population with positive treadmill test which can significantly improve the diagnostic performance of exercise stress test |
2 years |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/05/2018 |
| 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
|
This study is mainly done to compare the left ventricular deformation in patients with and without coronary artery disease having positive treadmill test using Tissue deformation imaging of echocardiography. 1. Primary Objective: To compare LV deformation with and without CAD among chronic stable angina patients by speckle tracking and torsion 2. Secondary Objective : To compare pre and post LV deformation in patients with CAD |