| CTRI Number |
CTRI/2024/03/064822 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of co-occurrence of autonomic dysfunction in patients with transient loss of consciousness. |
|
Scientific Title of Study
|
Assessment of coexistence of autonomic dysfunction in patients with syncope. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani Rao |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room no 212, 2nd floor, department of Cardiovascular Technology, MCHP, MAHE
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9403985501 |
| Fax |
|
| Email |
shivani3.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukund A Prabhu |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Cardiology, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9895137146 |
| Fax |
|
| Email |
mukundaprabhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukund A Prabhu |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Cardiology, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9895137146 |
| Fax |
|
| Email |
mukundaprabhu@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, Manipal |
| 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 Mukund A Prabhu |
Kasturba Hospital, Manipal |
HUTT test room, Cardiac ICU, 2nd floor, Kasturba Medical College, Manipal Academy of Higher Education
Udupi
KARNATAKA |
9895137146
mukundaprabhu@gmail.com |
|
|
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: R55||Syncope and collapse, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
participants with syncope above the age of 18 years |
|
| ExclusionCriteria |
| Details |
1. Participants who present with postural orthostatic tachycardia syndrome
2. Participants with cardiovascular diseases such as:
-Arrhythmias.
-Ischemic heart disease (IHD).
-Cardiomyopathies.
-Valvular heart diseases (VHD).
-Congenital heart diseases (CHD).
- Pericarditis
-Pacemaker implantation.
-Cardiac tumors or thrombus.
3. Pregnant women
4. participants with poor echo window.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
LVOT VTI
Cardiac Output
Cardiac Index
Stroke volume index
Left ventricular stroke work index
Myocardial performance index |
All outcomes at baseline, syncope and recovery stages. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
02/04/2024 |
| 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)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will be conducted after Institutional Research Committee and Institutional Ethics
Committee approval and CTRI registration. Participants satisfying the inclusion
criteria will be carefully chosen for the study. Participants with syncope referral
for Head Up Tilt Table Test will be undergoing electrocardiogram (ECG) and
echocardiography screening test for cardiac evaluation. Details pertaining to the need of the test will be
explained to the participant and written informed consent will be taken for the same. Participants
with syncope and no known cardiovascular disease will undergo Head Up Tilt Table Test and autonomic
function testing. Autonomic function
test will be performed using heart rate variability as per standard guidelines
by 1996 Taskforce statement using time and frequency domain measures and the Italian protocol will be followed for the HUTT test. Various echocardiographic parameters will be
recorded and stored at every stage of the procedure of head up tilt table test. 2D echocardiography will be used for obtaining
standard views like (PLAX, A4C, A5C) and PW Doppler for LVOT VTI as a part of routine evaluation. |