| CTRI Number |
CTRI/2016/02/006646 [Registered on: 16/02/2016] Trial Registered Retrospectively |
| Last Modified On: |
07/03/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of blood vessel thickness and fat deposition in the blood vessels in patients undergoing surgeries not involving the heart or blood vessels |
|
Scientific Title of Study
|
Pre-operative vascular function assessment and perioperative vascular events in patients posted for elective non cardiac surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AjeetviswanathTP |
| Designation |
Junior resident, anesthesiology |
| Affiliation |
JIPMER |
| Address |
Flat-T1,plot 85-86, 1st cross, 2nd main road, Priyadarshini nagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9176591005 |
| Fax |
|
| Email |
avtp1989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SUMAN LATA |
| Designation |
Associate Professor, Department of anesthesiology and critical care |
| Affiliation |
JIPMER |
| Address |
DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE ,
JIPMER,PONDICHERRY
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9488830091 |
| Fax |
|
| Email |
sumanlatagupta13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SUMAN LATA |
| Designation |
Associate Professor, Department of anesthesiology and critical care |
| Affiliation |
JIPMER |
| Address |
DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE ,
JIPMER,PONDICHERRY
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9488830091 |
| Fax |
|
| Email |
sumanlatagupta13@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER , Dhanvantri Nagar, Pondicherry, 605006 |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
Dhanvantri nagar, Pondicherry 605006 |
| 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 |
| Dr AjeetviswanathTP |
JIPMER wards and OT complexes |
JIPMER, PONDICHERRY -605006
Pondicherry
PONDICHERRY |
9176591005
avtp1989@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER Institute Ethics Committee (Human studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients from the age group 18-65 years posted for elective non -cardiac surgeries with atleast 2 or more risk factors for endothelial dysfunction , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for elective non cardiac surgeries in JIPMER
and have atleast 2 or more risk factors for endothelial dysfunction
-hypercholesterolemia
hypertension
diabetes mellitus
chronic smoking
History of ischemic heart disease |
|
| ExclusionCriteria |
| Details |
Patients not willing to participate in the study
pregnant patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the prevalence of endothelial dysfunction and early atherosclerosis in patientswho are posted for non cardiac electuve surgeries in a tertiary health care center |
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of FMD , CIMT and FLP with cardiac and vascular events |
1.5 years |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/06/2015 |
| 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="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of the study is to find out the prevalence of endothelial dysfunction and early atherosclerosis in patients who are posted for non cardiac elective surgeries in a tettiary health center using flow mediated dilatation and carotid intima media thickness calculation. The hypothesis is that preoperative vascular functional assessment can help in the monitoring of perioperative vascular events in elective non cardiac surgeries. |