| CTRI Number |
CTRI/2020/06/026072 [Registered on: 23/06/2020] Trial Registered Prospectively |
| Last Modified On: |
21/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing hemodynamic changes during minimal invasive Coronary artery bypass and conventional coronary artery bypass grafting |
|
Scientific Title of Study
|
A cross sectional observation study on comparison of hemodynamic changes between conventional off pump coronary artery bypass and minimally invasive off pump coronary artery bypass during Left anterior descending and obtuse marginal grafting |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KAMALAKKANNAN G S |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SRIHER |
| Address |
NO 1, RAMACHANDRA NAGAR, PORUR, CHENNAI.
NO 1, RAMACHANDRA NAGAR, PORUR, CHENNAI.
Chennai
TAMIL NADU
600116
India |
| Phone |
9791174372 |
| Fax |
|
| Email |
anaeskamal2006@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KAMALAKKANNAN G S |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
NO 1, RAMACHANDRA NAGAR, PORUR, CHENNAI.
NO 1, RAMACHANDRA NAGAR, PORUR, CHENNAI.
Chennai
TAMIL NADU
600116
India |
| Phone |
9791174372 |
| Fax |
|
| Email |
anaeskamal2006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KAMALAKKANNAN G S |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
NO 1, RAMACHANDRA NAGAR, PORUR, CHENNAI.
NO 1, RAMACHANDRA NAGAR, PORUR, CHENNAI.
Chennai
TAMIL NADU
600116
India |
| Phone |
9791174372 |
| Fax |
|
| Email |
anaeskamal2006@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
24 and 26, LAKSHMI STREET, KILPAUK. |
| Type of Sponsor |
Research institution |
|
|
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 |
| KAMALAKKANNAN G S |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
NO 1, RAMACHANDRA NAGAR
Chennai
TAMIL NADU |
9791174372
anaeskamal2006@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra University (SRU), Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.All elective CABG
2.EF>35 |
|
| ExclusionCriteria |
| Details |
1.Patients with left ventricular ejection fraction (LVEF) <35%,
2.Patients requiring preoperative inotropic support
3.Intra-aortic balloon counter pulsation
4.Emergency CABG
5.Patients not willing to participate in study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic response during grafting as measured by perfusion index (PI), Central venous pressure, mean arterial pressure and heart rate. |
Base line before grafting, Starting of grafting, 3 min into grafting and End of grafting. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tissue perfusion as measured by serum lactate |
nil |
|
|
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)
|
31/07/2020 |
| 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="6"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To compare the peripheral perfusion by means of mean arterial pressure and perfusion index between convestional and minimal invasive off pump coronary artery bypass during grafting. |