| CTRI Number |
CTRI/2024/03/063750 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
06/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Radiation Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of nuclear scan in stiff heart disease |
|
Scientific Title of Study
|
Predictive value of strain echocardiography in the diagnosis and outcome
of restrictive cardiomyopathy in comparison with technetium -99m-pyrophosphate scintigraphy |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vidya Nayak |
| Designation |
Assistant Professor-Selection Grade |
| Affiliation |
Manipal College Of Health Professions |
| Address |
Room 212,Second floor, Department of CVT, MCHP, MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844624003 |
| Fax |
|
| Email |
Vidyakabyadi@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Vidya Nayak |
| Designation |
Assistant Professor-Selection Grade |
| Affiliation |
Manipal College Of Health Professions |
| Address |
Room 212,Second floor, Department of CVT, MCHP, MAHE Manipal
KARNATAKA
576104
India |
| Phone |
9844624003 |
| Fax |
|
| Email |
Vidyakabyadi@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Vidya Nayak |
| Designation |
Assistant Professor-Selection Grade |
| Affiliation |
Manipal College Of Health Professions |
| Address |
Room 212,Second floor, Department of CVT, MCHP, MAHE Manipal
KARNATAKA
576104
India |
| Phone |
9844624003 |
| Fax |
|
| Email |
Vidyakabyadi@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| 3rd floor, OPD Block, Department of Cardiology and Ground floor , Shirdi Block, Department of Nuclear Medicine, Kasturba hospital Manipal |
|
|
Primary Sponsor
|
| Name |
Manipal University |
| Address |
Research Data Management, O/o Directorate of Research, MAHE |
| 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 Krishnananda Nayak |
Kasturba Hospital |
3rd floor, OPD Block, Cardiac Non-Interventional Lab, Department of Cardiology and Ground floor , Shirdi Block, Department of Nuclear Medicine, Kasturba hospital Manipal
Udupi
KARNATAKA |
9964015487
krishnananda.n@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: I425||Other restrictive cardiomyopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/A |
N/A |
| Intervention |
Single photon emission computed tomography(SPECT) |
Single photon emission computed tomography gamma camera (SPECT-CT)will be performed where each subject will be intravenously injected with:
Dose-15-20 mCi
Drug used- 99m -technetium -pyrophosphate radiotracer(Tc99m-PYP)
Duration-Approximately 3 hours
At every hour after injection a planar scan will be performed and the images will be stored for post processing, image reconstruction and data analysis.
Frequency-once at baseline. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age above 18 years
Suspected/diagnosed restrictive cardiomyopathy
Suspected/Diagnosed Amyloidosis |
|
| ExclusionCriteria |
| Details |
Breast feeding mothers
Previously documented hypersensitivity reaction
History of MI
History of life threatening arrythmias
End stage heart failure
LV dysfunction with serious LVOTO
Severe hypertension
Recent PTE , DVT , active endocarditis , myocarditis or pericarditis
LBBB
Hypotension
Bradycardia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Global longitudinal Strain left ventricle(%)
RV free wall strain(%)
LA strain(%) |
Taken once at baseline,no follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Area length Ejection fraction
Tricuspid Annular Plane Systolic Excursion
Right Ventricular Systolic
pressure
Diastolic Function E & A
Left Ventricular Volumes at end systole & end diastole
Tissue Doppler Imaging left ventricular septal & lateral wall |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
01/04/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
After IEC clearance and CTRI registration, this Interventional single arm study will be conducted. Patients with diagnosed RCM at Kasturba hospital, Manipal will be enrolled in this pilot study. Cases are selected if willing to give informed consent. Brief details of the patient’s demographic and clinical history are obtained. This includes age, gender, weight, height and comorbidity history like Hypertension and Diabetes.12 lead ECG will be recorded. ECG gated conventional echocardiography along with strain echocardiography (layer specific strain) will be performed and recorded. Strain echocardiographic analysis will be performed offline with the already available recorded echo images and will be stored for future references ,where LVEF, RV parameters, strain and strain rate will measured at baseline. Standard views will be taken with patient lying in left lateral decubitus position. Standard views like parasternal long axis and short axis at three levels of LV and apical 4,5 ,3 and 2 chamber views were recorded and stored. LVEF measurements will be taken by M mode and Simpson’s method. These images will be stored for offline analysis of strain. These patients will be later taken for single photon emission computed tomography gamma camera (SPECT-CT) where each subject will be intravenously injected with 740 MBq 99m -technetium -pyrophosphate radiotracer, post one hour after injection a planar scan will be performed and the images will be stored for post processing image reconstruction and data analysis. Strain echocardiographic parameters will be compared with 99m -technetium - pyrophosphate imaging results and assessed to see which among the two is a better predictor for the outcomes (sensitivity and specificity values will be calculated). |