Accelerating Access and Improving Imaging in Heart Failure Care (A2I2HF) Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI-assisted point-of-care ultrasound (POCUS).
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This is a prospective, multicenter, cluster randomised trial which will assess the feasibility and acceptability of AI-assisted point of care echocardiography on HF detection and downstream care processes for patients with suspected HF discharged from the Emergency Department.
Detailed description
Heart failure remains underdiagnosed in frontline care settings, in part due to limited access to timely echocardiography. Recent advances in artificial intelligence (AI)-assisted echocardiography may facilitate scalable bedside screening through automated image acquisition support and interpretation.
This is a prospective, multicenter, cluster randomised trial which will assess the feasibility and acceptability of routine implementation of AI-assisted point of care echocardiography on HF detection and downstream processes of care for patients with suspected HF being discharged from the Emergency Department.
This study will be carried out at 2 participating Emergency Departments (EDs) in Alberta, Canada. Each ED site will alternate monthly between Intervention (AI-assisted echocardiography) and Control (Usual Care) periods.
During intervention periods, patients with suspected HF will undergo AI-assisted echocardiography using a handheld point of care EchoNous Kosmos device by the treating ED physician. The US2.ai algorithm will generate an AI-automated echo report. During control periods, patients will be managed according to usual care.
Interventions
- Device AI-assisted point-of-care ultrasound (POCUS)
ED physicians at both sites will be provided with 1 session of in person training in the use of the AI-assisted POCUS device within 4 weeks of randomization including, * Device set up * Demo of patient exam with POCUS device (to be used within its CE/Health Canada marked intended purpose or where deemed clinically appropriate by the treating physician). * Generation of AI-automated echocardiogram report for LVEF and diastolic dysfunction.
Primary outcome measures
- Feasibility of AI Assisted Point of Care Echocardiography Implementation [Time frame: During the enrollment period.]
Secondary outcome measures (6)
- Diagnosis of heart failure (HF) within 90 days [Time frame: At 90 days.]
- Downstream health care resource utilization at 90 days and 1 year (e.g. rates of requests for echocardiography, cardiology referral, primary care appointments, HF hospitalization). [Time frame: At 90 days and 1 year.]
- Proportion of patients with HF receiving GDMT within 90 days [Time frame: At 90 days.]
- Difference in ratio of the incidence of diagnoses of HF via hospital admission-based versus community-based pathways [Time frame: At 90 days.]
- Uptake and utilization: differential rates of uptake and utilization of AI Assisted echocardiography in the emergency department [Time frame: During the enrollment period.]
- Determinants of uptake and utilization of AI assisted echocardiography in the emergency department (clinician questionnaire) [Time frame: During the enrollment period.]
Eligibility criteria
Inclusion criteria
- Adult patients age ≥18 years presenting to the emergency department (ED);
- with signs or symptoms of HF as per the treating physician and
- elevated natriuretic peptides (NT-proBNP >125pg/mL or BNP >50pg/mL), drawn as part of standard of care of evaluation in the ED.
Exclusion criteria
- prior documented diagnosis of HF;
- any patient receiving renal replacement therapy;
- any patient receiving comfort or palliative care;
- pregnant or nursing patients;
- patient is planned for admission.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07624565 · A2I2HF