| CTRI Number |
CTRI/2025/10/095629 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
05/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Exploring Heart Conditions Not Caused by Blocked Arteries |
|
Scientific Title of Study
|
Study Of Clinical and Imaging Profile of Non Ischaemic Cardiomyopathy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivam Goel |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Medicine, Kasturba Hospital, udupi-hebri road, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8882956900 |
| Fax |
|
| Email |
shivamgoel997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. RAMA BHAT |
| Designation |
PROFESSOR |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Medicine, Kasturba Hospital, udupi-hebri road, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9945272251 |
| Fax |
|
| Email |
ram.bhat@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivam Goel |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Medicine, Kasturba Hospital, udupi-hebri road, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8882956900 |
| Fax |
|
| Email |
shivamgoel997@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. Shivam Goel |
| Address |
Department Of Medicine, Kasturba Hospital, Udupi-Hebri road, Madhav Nagar, Manipal, Karnataka-576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 Shivam Goel |
Kasturba Hospital |
Department Of Medicine and Department Of Cardiology, Udupi-hebri road, madhav nagar, Manipal, Karnataka
Udupi
KARNATAKA |
8882956900
shivamgoel997@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: I420||Dilated cardiomyopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of Cardiomyopathy (outpatient and inpatient) including
Alcoholic Cardiomyopathy
Peripartum Cardiomyopathy
Dilated Cardiomyopathy
Hypertrophic Cardiomyopathy
Arrhythmogenic Cardiomyopathy
Restrictive Cardiomyopathy
Takotsubo Cardiomyopathy
|
|
| ExclusionCriteria |
| Details |
Patient with known Ischaemic Cardiomyopathy
Acute alcoholic cardiomyopathy- Wet beri beri
Chronic kidney Disease
Acute decompensated heart disease due to systemic disease/ sepsis
Significant valvular heart disease
Hypertensive heart disease
Congenital heart disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the clinical characteristics and imaging findings in patients with non-ischemic cardiomyopathy (NICM), with the aim of identifying key diagnostic markers, patterns of disease progression, and risk factors for adverse outcomes such as arrhythmias, sudden cardiac death, and advanced heart failure. |
2 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
16/10/2025 |
| 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 Yet Recruiting |
| 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
|
The proposed study, titled “Study of Clinical and Imaging Profile of Non-Ischaemic Cardiomyopathy (NICM)”, is a cross-sectional study planned to be conducted at Kasturba Hospital, Manipal, between September 2025 and September 2027. The aim is to evaluate the clinical and imaging profiles of different types of NICM, determine their underlying causes, and explore the correlation between imaging findings and clinical presentations to enhance risk prediction, prognosis, and management strategies. A total of 62 patients will be enrolled, calculated based on a 10% prevalence of dilated cardiomyopathy using Lemeshow’s formula. Adults over 18 years diagnosed with various forms of NICM, such as alcoholic, peripartum, dilated, hypertrophic, arrhythmogenic, restrictive, and Takotsubo cardiomyopathy, will be included, while patients with ischemic cardiomyopathy, significant valvular or congenital heart disease, hypertensive heart disease, chronic kidney disease, or acute systemic causes of heart failure will be excluded. Participants will be recruited from outpatient and inpatient departments, and data will be collected through clinical interviews, laboratory investigations (e.g., NT Pro-BNP, Trop-T, CRP), and advanced imaging techniques such as ECG, echocardiography, cardiac MRI, CT angiogram, PET CT, SPECT, and endomyocardial biopsy as needed. Statistical analysis will be performed using SPSS v23, employing appropriate tests based on data distribution. The study has minimal risks, limited to patient anxiety or missing data, and is expected to provide significant benefits by enabling personalized treatment plans, improving the prediction of complications like arrhythmias, sudden cardiac death, and severe heart failure, and enhancing understanding of disease phenotypes. Ethical clearance, CTRI registration, and informed consent will be obtained before initiation. This research is of national importance as it addresses the gaps in understanding NICM, validates newer diagnostic criteria, and leverages advanced imaging to optimize patient outcomes. |