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Establishing normal indian reference values for echocardiography: a retrospective study

Normal Indian Reference Values and Analysis for Nationwide Adult Echocardiography: NIRVANA Stud - NILL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/12/078053
Enrollment
7000
Registered
2024-12-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Sponsors

Rhythm Heart and Critical Care
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age: Adults aged 20 years and above. 2. Gender: Both male and female participants. 3. Echocardiographic Readings: Participants with normal echocardiographic parameters based on existing clinical records. 4. Medical History:No history of diabetes, hypertension, or any cardiac illness. o No history of significant systemic diseases or malignancies. 5. Body Composition: Participants with body surface area (BSA)-indexed echocardiographic measurements within normal ranges. 6. Regional Representation:Data will be drawn from participants across various regions to ensure national representation.

Exclusion criteria

Exclusion criteria: 1. Pre-existing Cardiac Conditions: Participants with structural heart abnormalities (e.g., congenital or acquired). Any prior diagnosis of heart disease (including ischemic heart disease, cardiomyopathies, or valvular heart diseases). 2. Systemic Illnesses: Participants with a history of systemic diseases (e.g., autoimmune diseases, cancer) or malignancy. 3. Pregnancy and Lactation: Pregnant and lactating mothers will be excluded due to potential physiological changes in cardiac dimensions during these conditions. 4. Lifestyle Factors:Smokers (both current and former, if smoking has significantly affected cardiac health). Chronic alcoholics (participants with a history of heavy alcohol consumption). 5. Athletes: Athletes involved in regular intensive training will be excluded due to potential alterations in cardiac dimensions caused by athletic conditioning. 6. Abnormal Cardiac Dimensions:Participants with any deviation from normal cardiac dimensions detected through pre-existing echocardiographic data will be excluded to maintain the integrity of the normal dataset. 7. Incomplete Medical Records: Participants with incomplete or missing echocardiographic data or essential clinical information will not be included.

Design outcomes

Primary

MeasureTime frame
Establishment of normal echocardiographic reference values for healthy Indian adults.Timepoint: Within 2 weeks of the start of trial

Secondary

MeasureTime frame
Evaluation of Gender-Specific Differences: Analyze variations in echocardiographic parameters between male & female participants to establish gender-specific reference ranges. Age-Stratified Reference Values: Determine how echocardiographic parameters vary across different age groups to provide age-specific normal values. Regional Variations: Assess potential geographic or regional differences in echocardiographic parameters among participants from different parts of India. Comparison with International Reference Values: Compare the established Indian-specific values with existing global echocardiographic reference standards to identify significant deviations.Timepoint: Within 2 weeks of start of the trial

Countries

India

Contacts

Public ContactHARSHAWARDHAN DHANRAJ RAMTEKE

Rhythm Heart and Critical Care

harshawardhanramteke7@gmail.com8369525334

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026