An interventional study of Smartphone large language model assistance (GPT-4o, version-locked) in Acute Coronary Syndromes, ST Elevation Myocardial Infarction and Non-ST Elevated Myocardial Infarction, sponsored by École Supérieure de Soins Ambulanciers - College of Higher Education in Prehospital Care. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by École Supérieure de Soins Ambulanciers - College of Higher Education in Prehospital Care · Not applicable, Interventional, and Diagnostic
Among 42 studies in Acute Coronary Syndrome with a site in Switzerland — 11 open to participants now, 12 under way, 2 of them phase 3. Acute Coronary Syndrome · Switzerland.
Among the 42 studies in Acute Coronary Syndrome with a site in Switzerland, this one is the 24th largest by planned enrollment of the 29 interventional ones, is one of 4 that started in 2026, is one of 13 with no phase, reaches primary completion later than 0 of the 11 other live ones, and was the 42nd registered.
1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.
This study's planned enrollment of 144 is below the median of 200 across 865 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →11 of the 42 studies in Acute Coronary Syndrome with a site in Switzerland are open now, in 12 countries. Each count lists the studies.
Of the 196 Acute Coronary Syndrome studies recruiting now, 144 (73%) set no upper age limit and 19 (10%) stop at 75 or younger; 14 take children under 18; 15 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →42 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 4 started in 2026.
Median enrollment 1,200 across the 29 interventional studies, 2,498 across the 13 observational. Of the 26 that completed or were terminated, 8 (31%) have results posted.
17 of 42 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with École Supérieure de Soins Ambulanciers - College of Higher Education in Prehospital Care as lead sponsor.
École Supérieure de Soins Ambulanciers - College of Higher Education in Prehospital Care has 1 study filed under Acute Coronary Syndrome — fewer than ten, so there is no comparison to draw.
7 of the studies in Acute Coronary Syndrome with a site in Switzerland that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07102628Phase 3Novartis PharmaceuticalsEvaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes | 2027-02-11 |
| NCT07810686École Supérieure de Soins Ambulanciers - College of Higher Education in Prehospital CareSmartphone AI Assistance for Prehospital ECG Interpretation | 2026-11-30 |
| NCT07597031Matthias Wilhelm, MDFeasibility Study of a Digital Interactive Life-style Platform for Individuals After Rehabilitation | 2027-02-01 |
| NCT04000061University Hospital, Basel, SwitzerlandHeart Failure-USB: Prediction and Progression | 2027-04-04 |
| NCT07091682Biotronik AGSafety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions | 2027-06 |
Among the 42 studies in Acute Coronary Syndrome with a site in Switzerland, from their registry updates:
Prehospital providers interpret 12-lead electrocardiograms (ECGs) under time pressure and without immediate expert support. Missed acute coronary occlusion - occlusion myocardial infarction (OMI) - delays reperfusion, while false positive interpretations trigger unnecessary catheterization laboratory activations. Multimodal large language models (LLMs) available on any smartphone can now analyze a photographed ECG, and prehospital providers have begun using them spontaneously. No randomized trial has evaluated whether this practice improves diagnostic performance.
This randomized controlled trial compares the diagnostic performance of prehospital providers interpreting ECG clinical vignettes with and without mandatory assistance from a single, version-locked smartphone large language model. Participants - paramedics, emergency medical technicians, nurses and physicians practicing in prehospital care in French-speaking Switzerland - are randomized 1:1 on a dedicated digital platform and answer 14 clinical vignettes presented in individually randomized order. Each vignette is built around a real, anonymized 12-lead ECG obtained during routine clinical care.
The primary outcome is the proportion of vignettes for which the participant correctly identifies the presence or absence of an OMI. Secondary outcomes are sensitivity, specificity, and the accuracy of the prehospital priority decision level.
Design and setting. Two-arm parallel-group randomized controlled trial conducted on a dedicated digital platform. Phase 1 takes place during a single in-person session at the Swiss French-speaking prehospital clinical research conference (Morat, Switzerland, 2 September 2026). Phase 2 extends recruitment to prehospital emergency services across French-speaking Switzerland (September to November 2026) using an identical standardized protocol.
Randomization. Individual 1:1 allocation performed automatically by the platform using permuted blocks of variable size (4 to 6), without stratification, after the demographic questionnaire and before the first vignette. Allocation cannot be changed once assigned. The presentation order of the 14 vignettes is independently randomized for each participant, which neutralizes position effects and prevents copying between neighbouring participants.
Intervention. Participants allocated to the intervention arm must consult the study-imposed large language model for every vignette before submitting their answer; the platform locks the submit button until use of the tool is confirmed. A single model (OpenAI GPT-4o) in an API version locked for the entire study is used by all participants, with a standardized, non-modifiable prompt identical for every participant and every vignette. Participants cannot add text, ask follow-up questions, or provide additional clinical context. Exposure to the tool is mandatory, but adherence to its interpretation is not: participants remain free to base their final answer on their own clinical reasoning. Control participants interpret the same ECGs unaided, with smartphones turned face down and out of reach.
Reference standard. For each vignette, the expected answers were defined a priori by the study cardiologist and locked, with any subsequent modification time-stamped in the platform audit log. The reference standard is the answer expected of a prehospital provider at the point of care, anchored on coronary angiography wherever angiography is discriminant. For non-ischaemic mimics, the expected answer depends on whether the acute presentation allows the condition to be distinguished from a coronary occlusion: it does not for the Takotsubo case included in the study, whose expected answer is therefore "yes", whereas acute pericarditis, being usually recognizable, has an expected answer of "no". This pre-specified departure from a purely angiographic standard is reported as such, and the primary analysis is repeated in a sensitivity analysis in which all mimics are classified as non-OMI.
Blinding. Participants and investigators cannot be masked. The statistician conducting the primary analysis receives coded group labels only, and the allocation key is released after database lock and approval of the statistical analysis plan.
Statistical analysis. Mixed-effects logistic regression with correct OMI identification at vignette level as the dependent variable, arm as the main fixed effect, grouped ECG category as a fixed covariate, and random intercepts for participant and for vignette. Intention-to-treat, alpha 0.05 two-sided. The target is 130 evaluable participants (65 per arm), giving 80% power to detect an absolute increase from 0.65 to 0.80 with an intraclass correlation up to approximately 0.43. Allowing for approximately 10% of sessions to be abandoned before completion, planned enrollment is 144 (72 per arm).
ECG material. All tracings originate from routine clinical care at the Geneva University Hospitals, were selected by a cardiologist to cover predefined electrocardiographic categories, and were anonymized at source before transmission to the research team. No patient is enrolled, followed or contacted, and the research team holds no key allowing re-identification.
Pilot. A technical pilot involving a small number of prehospital providers was conducted before the study start date to test the platform. Pilot sessions took place outside the standardized study conditions and are identified in the database by a dedicated centre code; their data are excluded from all analyses, as pre-specified in the protocol.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants interpret each of the 14 ECG vignettes without any assistance. Smartphones are turned face down and out of reach for the duration of the session. No intervention is administered.
Participants must consult the study-imposed large language model for every vignette before submitting their answer. The platform locks the submit button until use of the tool is confirmed. Participants remain free not to follow the interpretation produced by the model and may base their final answer on their own clinical reasoning.
Diagnostic Test: Smartphone large language model assistance (GPT-4o, version-locked)
The platform transmits the ECG image to a single large language model (OpenAI GPT-4o, API snapshot gpt-4o-2024-08-06), locked for the entire study, together with a standardised prompt identical for all participants and all vignettes: "I am on an urgent prehospital call with a patient who presents this ECG. Analyse it and tell me what you think." Participants cannot modify the prompt, ask follow-up questions or provide additional clinical context. The model version and system fingerprint returned by the API are recorded for every call. The model's interpretation is displayed within the vignette. Use of the tool is mandatory; adherence to its interpretation is not.
Also known as: ChatGPT, gpt-4o-2024-08-06
Proportion of vignettes with correct identification of occlusion myocardial infarction (OMI) status
For each of the 14 vignettes, the participant answers a binary question: "At this stage of care, is an OMI (acute coronary occlusion) likely? Yes / No". Responses are scored against a reference standard defined a priori, vignette by vignette, by the study cardiologist and locked before data collection. This reference standard is the answer expected of a prehospital provider at the point of care, anchored on coronary angiography wherever angiography is discriminant. For non-ischaemic mimics the expected answer depends on whether the acute presentation allows the condition to be distinguished from a coronary occlusion: it does not for the Takotsubo case (expected answer "yes"), whereas acute pericarditis is usually recognisable (expected answer "no"). This pre-specified departure from a purely angiographic standard is reported as such, and the analysis is repeated in a sensitivity analysis classifying all mimics as non-OMI. The outcome is the proportion of correctly classified vignettes
Time frame: Single study session, approximately 90 minutes; 14 vignettes per participant
Sensitivity of OMI detection
Proportion of correctly identified OMI among vignettes whose expected answer is "yes", compared between arms. Analysed by mixed-effects logistic regression restricted to these vignettes, with arm as fixed effect and a random intercept per participant.
Time frame: Single study session, approximately 90 minutes
Specificity of OMI detection
Proportion of correctly identified non-OMI among vignettes whose expected answer is "no" (non-occlusive ischaemia, indeterminate ischaemia, recognisable non-ischaemic mimics, normal or non-specific ECGs), compared between arms. Same modelling approach as for sensitivity.
Time frame: Single study session, approximately 90 minutes
Accuracy of the prehospital priority decision level
Proportion of vignettes for which the participant selects the correct prehospital priority decision level, on a pre-specified five-level scale ranging from high-risk acute coronary syndrome with activation of the STEMI pathway to clearly non-cardiac symptoms. The expected level is defined a priori for each vignette and locked before data collection.
Time frame: Single study session, approximately 90 minutes
Diagnostic accuracy on the closed-list diagnosis question
For each vignette the participant selects a single diagnosis from a closed list of 86 items grouped in 8 families, using a filterable selector. Two variables are produced automatically: exact match with the expected diagnosis, and match with the expected diagnosis or with any diagnosis pre-specified as clinically acceptable. Reported descriptively by ECG category and by arm, then modelled by mixed-effects logistic regression if numbers allow. The primary analysis uses the exact-or-acceptable variable; the strict variable is reported as a sensitivity analysis.
Time frame: Single study session, approximately 90 minutes
Self-reported confidence and calibration
Confidence in the answer is reported by the participant for each vignette on a five-point Likert scale of self-reported diagnostic confidence, ranging from 1 (not at all confident) to 5 (very confident). A higher score indicates greater self-reported confidence; confidence is a descriptive measure and a higher score is not in itself a better outcome. Confidence is compared between arms by mixed-effects ordinal logistic regression. Calibration is assessed as the concordance between reported confidence and the actual correctness of the answer, using calibration curves and the Brier score, which ranges from 0 to 1, a lower score indicating better calibration.
Time frame: Single study session, approximately 90 minutes
Self-reported influence of the AI on the final answer
Degree to which the participant reports having been influenced by the model's interpretation, on a five-point Likert scale, collected for each vignette in the intervention arm only. Analysed descriptively and in relation to the correctness of the answer. No comparison between AI tools is conducted, the model version being fixed.
Time frame: Single study session, approximately 90 minutes
Response time per vignette
Time from display of the vignette to submission of the answer, measured automatically in seconds by the platform. Analysed by linear mixed-effects model on the log of the response time, with arm as fixed effect and a random intercept per participant; a sensitivity analysis compares individual median times between arms. A longer time is expected in the intervention arm owing to consultation of the model, and is treated as a feasibility outcome for prehospital use.
Time frame: Single study session, approximately 90 minutes
Diagnostic performance by level of training
Diagnostic performance according to the participant's level of training (emergency medical technician, paramedic, nurse, physician), and interaction between arm and level of training. The study is not powered for this comparison and the distribution of training levels depends on spontaneous recruitment; results are hypothesis-generating and reported with confidence intervals only. A minimum of 10 participants per category is required for separate analysis, failing which categories are pooled according to a rule documented before unblinding.
Time frame: Single study session, approximately 90 minutes
Plan to share: Yes — Fully anonymised individual participant data - responses to all vignettes, demographic variables and platform-generated technical variables - will be deposited in an open repository (Zenodo or OSF) at the time of publication, in accordance with FAIR principles. The ECG tracings themselves are excluded from this deposit: they originate from routine clinical care at the Geneva University Hospitals, which authorise their use for this study only and do not permit transmission to third parties. Requests concerning the tracings must be addressed to the Geneva University Hospitals.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: From the date of publication, with no end date.
Access criteria: Open access, no restriction, no request procedure.
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Nov 2026, 2 months after the start.
Of 210 non-industry interventional studies with no phase under Acute Coronary Syndrome, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 46. This study's planned 2 months is below that.
Counting every sponsor, half of 225 studies reached it within 34 months; a quarter within 18 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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