An interventional study of UPMC AF Prediction Model in Stroke, sponsored by Samir Saba. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Samir Saba · Not applicable, Interventional, and Treatment
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Among 1,994 studies in Stroke with a site in United States — 395 open to participants now, 492 under way, 17 of them phase 3. Stroke · United States.
Among the 1,994 studies in Stroke with a site in United States, this one is the 394th largest by planned enrollment of the 1,620 interventional ones that give a count, is one of 106 that started in 2026, is one of 1,124 with no phase, reaches primary completion later than 385 of the 490 other live ones, and was the 1,993rd registered.
8,268 studies on the registry are indexed under Stroke; 2,055 are open to participants now.
Browse Stroke studies →395 of the 1,994 studies in Stroke with a site in United States are open now. Recruiting first, the newest first:
University of Utah · Sites in United States
Ages 40–85
Carle Foundation Hospital · Sites in United States
Ages 18+
Weill Medical College of Cornell University · Sites in United States
Ages 18–79
Neuralink Corp · Sites in United States
Ages 18+
Casa Colina Hospital and Centers for Healthcare · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 1,415 Stroke studies recruiting now, 695 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 195 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,994 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 173 · Phase 2 235 · Phase 3 126 · Phase 4 43
First in 1980; this study’s year is marked. 106 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 49 across 6,027 interventional studies indexed under Stroke.
Median enrollment 40 across the 1,620 interventional studies, 153 across the 363 observational. Of the 1,328 that completed or were terminated, 563 (42%) have results posted.
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295 of 1,994 have an industry lead sponsor. The 10 most frequent:
Samir Saba is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Samir Saba has 1 study filed under Stroke — fewer than ten, so there is no comparison to draw.
164 of the studies in Stroke with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05065216Phase 3DiaMedica Therapeutics IncTreatment of Acute Ischemic Stroke (ReMEDy2 Trial) | 2026-12 |
| NCT03223220Phase 3Lower Merion Neurology Research FoundationQuelling of Excitotoxicity in Acute Stroke With Ketamine | 2026-12-31 |
| NCT05047172Phase 3University of FloridaComparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis | 2027-01-31 |
| NCT05691244Phase 3Pharmazz, Inc.Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke | 2027-09 |
| NCT05997914University of Massachusetts, WorcesterStorytelling for Reducing Gap in Anticoagulation Use in African Americans With Atrial Fibrillation | 2026-11 |
Add all 164 to your calendar (.ics) → With an account.
Among the 1,994 studies in Stroke with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Stroke is a major cause of disability and the second leading cause of death in adults. Some strokes are linked to atrial fibrillation (AF), a type of irregular heartbeat. When AF is found, doctors usually prescribe blood-thinning medicines to help prevent another stroke. If AF is not found, patients are usually treated with antiplatelet medicines, such as aspirin.
However, AF can be difficult to detect. Because of this, doctors may not know which treatment is best.
Our research team has developed computer programs that analyze a normal electrocardiogram (EKG) and predict whether a person may develop AF in the future. These programs have been shown to be highly accurate.
The goal of this study is to see how sharing these prediction results affects treatment decisions made by patients who have had an embolic stroke of undetermined source (ESUS) and their neurologist. An ESUS is a type of stroke where the exact cause cannot be identified.
Participants in the study will have their normal EKG analyzed using the prediction program. Researchers will then evaluate whether providing these results to the neurologist influences decisions about the patient's care.
Patients presenting to outpatient or inpatient stroke services or to the inpatient cardiac procedure unit for implantation of implantable cardiac monitor at the hospitals of UPMC and who have suffered an ischemic stroke without overt clinical etiology will be considered for participation in this clinical trial. The research coordinator for the trial will screen the inpatient services and outpatient clinics and will verify that any prospective subject meets all the inclusion and none of the exclusion criteria. Once this information is ascertained, the investigator, research coordinator, or both will approach the patient to explain the rationale of the study and its requirements after a clinician known to the participant has obtained their permission to be approached. After signing written informed consent, patients will be enrolled into the study whereby the normal sinus rhythm EKG will be analyzed using the novel machine learning method to assess the patient's risk for developing AF in the following year. Participants will undergo standard of care monitoring on an outpatient basis which includes initially a wearable monitor and then an implantable monitor if the wearable monitor does not reveal AF. If any monitoring reveals AF, then the patients will be on anticoagulation, as indicated in any patient with stroke and AF. This information will be shared with the treating neurologist.
Once a patient is enrolled, their baseline normal EKG will be analyzed using the machine learning algorithm and their risk category for developing AF will be determined. The results which are classified into low, intermediate, and high risk will be presented to the stroke team. The stroke specialists will then share these risk prediction data with their patient for shared decision-making regarding anticoagulation strategy -- oral anticoagulation (OAC) vs. Aspirin. When the information from the novel learning method is shared with the treating neurologist or stroke specialist, the research team will remind them that this is a research tool and has not been fully validated.
The machine learning algorithm, referred to for research purposes as the UPMC AF Prediction Model, was developed under STUDY20030038. The algorithm performance was tested and validated on more than 26,000 patients, 23% of whom developed AF over the course of one year after their original normal EKG. The algorithm performance shows an area under the Receiver Operating Characteristic curve of 0.800 with an F1 score of 0.42. Accordingly, the risk groups in the study were defined as follows, after consultation with stroke specialists:
A. Low risk group, based on a negative predictive value of 97.5% (i.e., only 2.5% of patients classified as low risk will develop AF over 1-year of follow-up) B. High risk group, based on a positive predictive value of 30% (i.e., 30% of patients classified as high risk will develop AF over 1-year of follow-up) C. Intermediate risk group, which will include patients who do not belong in either of the two previous risk groups
Patients will be followed up for 90 days for clinical events. Follow-up at 30 and 90 days will consist of phone calls and review of electronic health records. The rate of use of OAC will be assessed at 30 and 90 days in each AF risk category.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Patients presenting to outpatient or inpatient stroke services or to the inpatient cardiac procedure unit for implantation of implantable cardiac monitor at the hospitals of UPMC and who have suffered an ischemic stroke without overt clinical etiology will be considered for participation in this trial. Once a patient is enrolled, their baseline normal EKG will be analyzed using the machine learning algorithm and their risk category for developing AF will be determined. The results, which are classified into low, intermediate, and high risk, will be presented to the stroke team. The stroke specialists will then share these risk prediction data with their patient for shared decision-making regarding anticoagulation strategy (OAC vs. Aspirin). Patients will be followed up for 90 days for clinical events. Follow-up at 30 and 90 days will consist of phone calls and review of electronic health records. The rate of use of OAC will be assessed at 30 and 90 days in each AF risk category.
Device: UPMC AF Prediction Model
Enrolled patients' baseline normal EKG will be analyzed using the UPMC AF Prediction Model and their risk category for developing AF will be determined. The results, which are classified into low, intermediate, and high risk, will be presented to the stroke team. The stroke specialists will then share these risk prediction data with their patient for shared decision-making regarding anticoagulation strategy (OAC vs. Aspirin). Patients will be followed up for 90 days for clinical events. Follow-up at 30 and 90 days will consist of phone calls and review of electronic health records. The rate of use of OAC will be assessed at 30 and 90 days in each AF risk category.
Rates of Prescribing OAC versus Antiplatelet Agent
The primary endpoint of this trial is the rates of prescribing OAC versus antiplatelet agent after 30 days and after 90 days of patient enrollment, and before any diagnosis of AF is made. In the unlikely event that a patient is diagnosed with AF in the first 30 days after enrollment, their OAC status before the AF diagnosis is made will be recorded and used as the primary endpoint. Patients will be followed up for a total of 90 days for clinical events. All follow-up visits will consist of phone calls and review of electronic health records. The rate of use of OAC will be assessed at 90 days in each AF risk category.
Time frame: From enrollment until assessment at 90 days
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Sep 2028, 22 months later.
Of 3,111 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 22 months is close to that.
Counting every sponsor, half of 3,255 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Samir Saba