| CTRI Number |
CTRI/2024/03/064104 [Registered on: 13/03/2024] Trial Registered Prospectively |
| Last Modified On: |
01/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Left heart function assessment in diabetic and hypertensive patients |
|
Scientific Title of Study
|
Left atrial function in individuals with metabolic syndrome : A cross-sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
N Neethu Pai |
| Designation |
Postgraduate student |
| Affiliation |
Manipal College of Health Profession |
| Address |
Room No 212 2nd floor Department of Cardiovascular technology
MCHP MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9495550211 |
| Fax |
|
| Email |
paineethu123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Jyothi Samanth |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Profession |
| Address |
Department of Cardiovascular technology
MCHP MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9964586823 |
| Fax |
|
| Email |
samanth.jyothi@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
N Neethu Pai |
| Designation |
Postgraduate student |
| Affiliation |
Manipal College of Health Profession |
| Address |
Room No 212 2nd floor Department of Cardiovascular technology
MCHP MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9495550211 |
| Fax |
|
| Email |
paineethu123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Cardiology Kasturba Medical College Manipal Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal Academy of Higher Education |
| Address |
Kasturba Medical College and Hospital Tiger Circle Road Madhava
Nagar Manipal Udupi Karnataka PIN- 576104
|
| 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 Padmakumar R |
Kasturba Hospital Manipal |
Room no 37
New OPD
Department of Cardiology
Kasturba Medical College
Manipal Academy of Higher Education
Udupi
KARNATAKA |
9900921428
padma.kumar@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
All individuals having Metabolic Syndrome between the age group of 30 years to 55 years of age |
|
| ExclusionCriteria |
| Details |
Participants with previously diagnosed cardiovascular disease including valvular heart disease ischemic heart disease previous cardiac surgery or percutaneous interventions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Left atrial strain
Left atrial volume index |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Left atrial volume
Left atrial area
Left atrial ejection fraction
Estimated Left ventricular filling pressure |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="260"
Sample Size from India="260"
Final Enrollment numbers achieved (Total)= "107"
Final Enrollment numbers achieved (India)="107" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/04/2024 |
| Date of Study Completion (India) |
31/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The study will be conducted after obtaining IRC and IEC approval and CTRI registration. After IRC, IEC and CTRI registration, stable participants aged between 30-55 years of age diagnosed with metabolic syndrome according to the NCEP ATP III criteria undergoing transthoracic echocardiography advised by Cardiologists will be recruited in the study. Test details will be explained to the subject and informed consent will be obtained. ECG gated standard views will be acquired using transthoracic echocardiography. Using 2D echocardiography, all the basic parameters including tissue Doppler velocities at septal and lateral wall are obtained. Conventional parameters like LA volume, LA area, LA EF and LA strain will also be obtained. Analysis of LA strain will be done offline using a presently marked semi-automated software Echo PAC version 202. |