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Comparing a Handheld AI Heart Scanner with a Standard Hospital Heart Scanner for Measuring Heart Pumping Strength in Adults

Agreement of AI-Driven Handheld Echocardiography for Global Longitudinal Strain Compared With Cart-Based Echocardiography - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/04/109306
Enrollment
90
Registered
2026-04-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: I501- Left ventricular failure, unspecified

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Intervention4: Nil: Nil

Sponsors

Care CIIGMA Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 years or more 2. Referred for clinically indicated transthoracic echocardiography (TTE) as part of routine care 3. Sinus rhythm at the time of echocardiographic examinations 4. Adequate acoustic windows to allow standard apical views (4-chamber, 2-chamber, and 3-chamber) on both handheld and cart-based systems, in the judgment of the operator 5. Able and willing to provide written informed consent

Exclusion criteria

Exclusion criteria: Atrial fibrillation at the time of echocardiographic examinations Frequent ventricular or supraventricular ectopy precluding reliable GLS assessment Paced rhythm at the time of imaging Poor image quality in any required apical view (4-, 2, or 3 chamber) rendering GLS analysis non-diagnostic Haemodynamic instability precluding safe completion of both examinations within the required timeframe Any condition making participation unsafe or interfering with image acquisition/interpretation (e.g., inability to lie in left lateral decubitus, severe respiratory distress) Refusal or inability to provide informed consent

Design outcomes

Primary

MeasureTime frame
Agreement between GLS derived from handheld echocardiography (analysed using US2.AI) and GLS obtained from cart-based echocardiography (reference standard), assessed by: Bland-Altman analysis mean bias and 95% limits of agreement Intraclass Correlation Coefficient (ICC) two-way random-effects, absolute-agreement model Timepoint: At the time of the single study visit (within the 30-minute imaging window)

Secondary

MeasureTime frame
Feasibility of GLS measurement with handheld + US2.AI (proportion of patients with successful GLS calculation), with 95% CITimepoint: Single Study Visit

Countries

India

Contacts

Public ContactDr Deepak Borde

Care CIIGMA Hospital

deepakborde2482@gmail.com7350357108

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026