| CTRI Number |
CTRI/2019/01/017308 [Registered on: 31/01/2019] Trial Registered Prospectively |
| Last Modified On: |
28/01/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Device Validation |
| Study Design |
Other |
|
Public Title of Study
|
A research study for detection of cardiac disease during pregnancy using a novel noninvasive device. |
|
Scientific Title of Study
|
Improved Detection of Cardiac Disease during Pregnancy using Acoustic Cardiography |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lavanya Kiran |
| Designation |
Consultant Gynaecologist |
| Affiliation |
Mazumdar Shaw Medical College, a unit of Narayana Hrudayalaya Ltd |
| Address |
Department of obstertrics and gynaecology, #258/A, Bommasandra Industrial Area, Anekal Taluk, Bangalore
Bangalore Rural
KARNATAKA
560099
India |
| Phone |
|
| Fax |
|
| Email |
drlavanya_kiran@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alben Sigamani |
| Designation |
Group Head - Clinical Research |
| Affiliation |
Mazumdar Shaw Medical College, a unit of Narayana Hrudayalaya Ltd |
| Address |
Department of Clinical Research #258/A, Bommasandra Industrial Area, Anekal Taluk, Bangalore
Bangalore Rural
KARNATAKA
560099
India |
| Phone |
|
| Fax |
|
| Email |
alben.sigamani.dr@narayanahealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alben Sigamani |
| Designation |
Group Head - Clinical Research |
| Affiliation |
Mazumdar Shaw Medical College, a unit of Narayana Hrudayalaya Ltd |
| Address |
Department of Clinical Research, #258/A, Bommasandra Industrial Area, Anekal Taluk, Bangalore
Bangalore Rural
KARNATAKA
560099
India |
| Phone |
|
| Fax |
|
| Email |
alben.sigamani.dr@narayanahealth.org |
|
|
Source of Monetary or Material Support
|
| Audicor Cardiometrics PVT LTD, Bengaluru, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Audicor Cardiometrics PVT LTD |
| Address |
Audicor Cardiometrics PVT LTD
A302, Wellington Park
Wellington Street, Richmond Town
Bengaluru, Karnataka 560025, India
|
| Type of Sponsor |
Other [Company] |
|
|
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 Lavanya Kiran |
Mazumdhar Shaw Medical Center, a unit of Narayana Hrudayalaya Ltd |
Department of obstertrics and gynaecology, #258/A, Bommasandra Industrial Area, Anekal Taluk, Bangalore
Bangalore Rural
KARNATAKA |
9845689827
drlavanya_kiran@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Health Medical Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O268||Other specified pregnancy relatedconditions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnancy, less than 30 Weeks
2. Age 18 years or older |
|
| ExclusionCriteria |
| Details |
1. Known allergic reaction to adhesive used in ECG electrodes
2. Any sore, incision or skin rash in the area of the upper left chest where the Audicor device would be
placed
3. History of pre-eclampsia or pregnancy induced hypertension in previous pregnancy.
4. Recent history, <12 months, stroke MI or cardiac arrest or peripheral vascular disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of the performance of cardiac disease screening using acoustic
cardiography during pregnancy and post-partum. |
Initial visit to 6 months after pregnancy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
01/02/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Cardiac disease during pregnancy is a
serious complication for both the mother and fetus. However, if detected early,
treatment is available and effective in reducing both morbidity and mortality.
Acoustic cardiography combined with medical history, symptoms and other metrics
such as blood pressure can provide safe and effective cardiac disease screening
during pregnancy with minimal discomfort or risk. The
primary goal of this study is to evaluate whether the combination of
simultaneously recorded ECG and heart sounds with advanced signal processing
analysis (acoustic cardiography) can improve the diagnosis of heart disease
during pregnancy. Acoustic cardiography produces measurements that reflect both
systolic and diastolic function in addition to standard ECG parameters and
rhythm information. This technology will be used in combination with medical
history, symptoms and blood pressure in a time effective screening system
designed specifically to be used during pregnancy and post-partum |