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Implementing AI-Powered Clinical Decision Support for Electrocardiography (ECG) Analysis: Advancing Equitable and Sustainable Cardiovascular Diseases Diagnosis and Management in Ethiopia (AI-SUSTAINS CVD Care): Hybrid Effectiveness-Implementation Design

Implementing AI-Powered Clinical Decision Support for Electrocardiography (ECG) Analysis: Advancing Equitable and Sustainable Cardiovascular Diseases Diagnosis and Management in Ethiopia (AI-SUSTAINS CVD Care): Hybrid Effectiveness-Implementation Design

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202511872360497
Enrollment
1000
Registered
2025-11-05
Start date
2025-06-25
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Cardiovascular diseases Cardiovascular diseases

Interventions

AI Powered ECG for Africa Platform with Clinical Decision Support

Sponsors

MI4People
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients of any age or sex suspected of having cardiovascular disease. Patients undergoing a 12-lead ECG at one of the participating hospitals. Patients (or their legal guardians) who provide informed consent to participate in the study. Patients whose ECG data can be uploaded to the AI-powered ECG4Africa platform for analysis.

Exclusion criteria

Exclusion criteria: Patients with incomplete or poor-quality ECG recordings that cannot be analyzed by the AI platform. Patients who decline or are unable to provide informed consent. Patients already enrolled in another interventional cardiovascular study that may interfere with ECG interpretation. Patients with conditions that prevent standard 12-lead ECG acquisition (e.g., severe skin conditions, limb amputations preventing electrode placement).

Design outcomes

Primary

MeasureTime frame
Diagnostic accuracy of the AI-powered ECG4Africa system compared with senior cardiologist interpretations, measured by sensitivity, specificity, and overall agreement in detecting cardiovascular abnormalities from 12-lead ECGs.

Secondary

MeasureTime frame
Turnaround time for ECG interpretation: Time from ECG acquisition to clinical decision support provided by the AI system. Clinician adherence to AI recommendations: Proportion of AI suggestions followed by physicians in clinical decision-making. Feasibility and usability of the AI system: Assessed through clinician feedback and system usage metrics. Capacity building outcomes: Number of clinicians trained and level of confidence in interpreting AI-assisted ECGs. Data completeness and quality: Proportion of ECGs successfully uploaded and analyzed on the AI platform.

Countries

Ethiopia

Contacts

Public ContactTsegab Alemayehu Bukate

Clinical Researcher Armauer Hansen Research Institute

tseguama@gmail.com+251926359702

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026