| CTRI Number |
CTRI/2024/04/066111 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
prospective study to assess effect of heart relaxation(diastolic) abnormality on outcomes after CORONARY ARTERY BYPASS GRAFT SURGERY ( CABG) |
|
Scientific Title of Study
|
A PROSPECTIVE STUDY TO ASSESS THE IMPACT OF DISTOLIC DYSFUNCTION ON POST-OPERATIVE OUTCOMES AFTER CORONARY ARTERY BYPASS GRAFT SURGERY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR VINAY KUMAR SHARMA |
| Designation |
DNB SUPERSPECILITY ( CARDIAC ANAESTHESIA) |
| Affiliation |
MAX SUPERSPECIALITY HOSPITAL, DEVKI DEVI FOUNDATION, EAST BLOCK, SAKET , NEW DELHI. |
| Address |
MAX SUPERSPECIALITY HOSPITAL, DEVKI DEVI FOUNDATION, EAST BLOCK, SAKET , NEW DELHI.
Max superspecility hospital,saket, new Delhi, 110017
New Delhi
DELHI
110017
India |
| Phone |
7232032777 |
| Fax |
|
| Email |
drwin1987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KUSHANT GUPTA |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
MAX SUPERSPECIALITY HOSPITAL |
| Address |
MAX SUPERSPECIALITY HOSPITAL, DEVKI DEVI FOUNDATION, EAST BLOCK, SAKET , NEW DELHI.
DEVKI DEVI FOUNDATION, EAST BLOCK, SAKET , NEW DELHI.
South
DELHI
110017
India |
| Phone |
7232032777 |
| Fax |
|
| Email |
kushant.gupta@maxhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KUSHANT GUPTA |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
MAX SUPERSPECIALITY HOSPITAL |
| Address |
MAX SUPERSPECIALITY HOSPITAL, DEVKI DEVI FOUNDATION, EAST BLOCK, SAKET , NEW DELHI.
DEVKI DEVI FOUNDATION, EAST BLOCK, SAKET , NEW DELHI.
South
DELHI
110017
India |
| Phone |
7232032777 |
| Fax |
|
| Email |
kushant.gupta@maxhealthcare.com |
|
|
Source of Monetary or Material Support
|
| max superspeciality hospital, DEVKI DEVI FOUNDATION, EAST BLOCK, SAKET , NEW DELHI. |
|
|
Primary Sponsor
|
| Name |
max superspeciality hospital, DEVKI DEVI FOUNDATION, EAST BLOCK, SAKET , NEW DELHI. |
| Address |
saket, new delhi |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 vinay kumar sharma |
cardiac ot and cardiac icu and ward |
max superspeciality hospital, DEVKI DEVI FOUNDATION, EAST BLOCK, SAKET , NEW DELHI.
South
DELHI |
7232032777
drwin1987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTE , EAST BLOCK, MAX SUPERSPECIALITY HOSPITAL, SAKET, NEW DELHI, |
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 |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
ALL ADULT PATIENTS (AGE ABOVE 18 YEARS) UNDERRGOING CABG SURGERY |
|
| ExclusionCriteria |
| Details |
REFUSAL FOR CONSENT, KIDNEY DISEASE, STRUCTURAL HEART DISESE, PREGNANT FEMALE, MORBID OBESITY, REDO CARDIAC SURGERY, ANEMIA, THYROID DISORDER, ARRHYTHMIA, PACEMAKER DEPENDENT, RECENT MYOCARDIAL INFRACTION |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| duration of intubation, new onset atrial fibrillation |
duration of intubation, new onset atrial fibrillation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| hospital length of stay,need of high oxygen support,respiratory complication,vas score, readmission to icu. 30 days mortality |
hospital length of stay,need of high oxygen support,respiratory complication,vas score, readmission to icu. 30 days mortality |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
03/05/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
we will do transesophageal echocardiography intra-operatively, which is a standard procedure intra-op for cardiac surgery. in this we will assess patients diastolic functions. and make 2 groups. one having normal diastolic function another with diastolic dysfunction. now we will see post-operative outcomes in these 2 group patiets like duration of intubation, onset of new atrial fibrillation, incidences of aki. |