Myocardial Infarction (MI)PREDICT-HSNCT07735338
Smartphone Application to PREDICT Real-Time Cardiovascular Risk for Heart Attack and Stroke
A study testing Smartphone application Antshrike in people with Myocardial Infarction (MI) and Stroke, run by Stanford University at 1 site in United States.
Trial summary
To assess the diagnostic accuracy of a smartphone application in predicting heart attack or stroke within 3-4 days in high-risk patients. Read more about this study
- Who is it for?
- Ages 40 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction (MI), Stroke
- What is being tested?
- Smartphone application Antshrike
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be able to provide electronic or written informed consent and be able to effectively communicate and understand the study procedures, risks, and required activities.
- Age 40 to 79 years.
- Be willing to wear a smartwatch continuously for 18 months and comfortable with using wearable devices or other technologies that monitor their data over time.
- Established ASCVD or at an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as anyone of the following:
- Evidence of atherosclerotic CAD on CT or invasive coronary angiogram defined as a coronary artery stenosis ≥ 20% but <50% in the left main coronary artery or a stenosis ≥ 20% but <70% in any other major coronary artery.
- Coronary artery calcium score ≥ 100 Agatston units.
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- High estimated10-year ASCVD risk ≥ 20% by pooled cohort equation.
- Intermediate estimated 10-year ASCVD risk 7.5% to <20% by pooled cohort equation with at least 2 of the following risk-enhancing factors:
- A first degree relative with history of premature ASCVD (males, age <55 years; females, age <65 years).
- History of premature menopause before age 40.
- History of maternal pregnancy complications (defined as a history of either preeclampsia, gestational hypertension, or gestational diabetes).
- South Asian ancestry.
- Chronic inflammatory disorders (defined as either rheumatoid arthritis, systemic lupus erythematosus, psoriasis covering ≥10% of body surface area, Crohn's disease, ulcerative colitis, or HIV/AIDS).
- High-sensitivity C-reactive protein (hsCRP) ≥2 mg/L documented in the 12 months preceding the screening visit, and, in absence of any underlying acute or inflammatory conditions.
- Lipoprotein (a) ≥50 mg/dL or ≥125 nmol/L at any time before the screening visit.
- Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2.
- Ankle branchial index (ABI) <0.9 with no symptoms of intermittent claudication.
- Metabolic syndrome: increased waist circumference, elevated triglycerides, elevated blood pressure, elevated glucose, and low HDL-C are factors
- Diabetes
Who cannot join
- The 10-year ASCVD risk <7.5%.
- Elevated troponin at baseline.
- Cognitive impairment.
- Neurological disorders that would impair their ability to provide informed consent or adhere to study protocols.
- Metastatic cancer or active cancer undergoing chemotherapy.
- Terminal illness.
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- Pregnant women or women of childbearing potential not using contraception.
- Current or past major psychiatric disorders (e.g., schizophrenia, bipolar disorder, severe depression) that could affect physiological or biometric data.
- Surgical or medical condition, which in the opinion of the Investigator, may place the participant at higher risk from his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study.
- Unwillingness or inability to comply with study procedures, including adherence to study visits, fasting blood draws and compliance with study protocol.
- Residing in an inpatient facility or bedbound
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stanford University
Stanford, California, 94305
Sandra Tsai, MD, 650-498-9000, stsai1@stanford.edu
Sandra Tsai, MD
About this study
Official title: Prospective Study of the Diagnostic Accuracy of a Smartphone Application to PREDICT Real-Time Cardiovascular Risk for Heart Attack and Stroke (PREDICT-HS)
To assess the diagnostic accuracy of a smartphone application in predicting heart attack or stroke within 3-4 days in high-risk patients.
- Conditions
- Myocardial Infarction (MI), Stroke
- Being tested
- Smartphone application Antshrike
- Medical subject headings
- Myocardial Infarction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone application AntshrikeDevice
All participants will wear a smart watch that has an application Antshrike, which will collect demographic data, health history, lifestyle factors, and biobehavioral data for 18 months.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone application Antshrike | Other | Participants wear the smartwatch throughout the day for 18 months other than when the smartwatch needs to be removed for charging or if the sensors fail. The study participant will be asked to follow instructions on the watch to manage. Receives: Device: Smartphone application Antshrike |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ASCVD events
ASCVD events include myocardial infarction (MI), ischemic stroke/transient ischemic attack (TIA), CV death, or clinically driven arterial revascularization or hospitalization.
Measured: Baseline through 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial Infarction (MI)Studies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Before Health Intelligence Ltd, Samsung Electronics Co., Ltd
- Responsible party
- Principal investigator, Sandra Anping Tsai, Stanford University
- Investigators
- Sandra Tsai, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735338
- Sponsor's protocol ID
- 86331
- Acronym
- PREDICT-HS
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No. Individual participant data collected during this study will not be shared with other researchers outside Stanford's primary research team and the adjudication team.
Publications
Turakhia MP, Desai M, Hedlin H, Rajmane A, Talati N, Ferris T, Desai S, Nag D, Patel M, Kowey P, Rumsfeld JS, Russo AM, Hills MT, Granger CB, Mahaffey KW, Perez MV. Rationale and design of a large-scale, app-based study to identify cardiac arrhythmias using a smartwatch: The Apple Heart Study. Am Heart J. 2019 Jan;207:66-75. doi: 10.1016/j.ahj.2018.09.002. Epub 2018 Sep 8.
PubMed 30392584Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183.
PubMed 31722151
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Diagnostic Accuracy of a Smartphone Application to PREDICT Real-Time Cardiovascular Risk for Heart Attack and Stroke (PREDICT-HS)
- ClinicalTrials.gov ID
- NCT07735338
- Acronym / sponsor ID
- PREDICT-HS / 86331
- Conditions
- Myocardial Infarction (MI), Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Before Health Intelligence Ltd, Samsung Electronics Co., Ltd
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the diagnostic accuracy of a smartphone application in predicting heart attack or stroke within 3-4 days in high-risk patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smartphone application Antshrike | Other | Device: Smartphone application AntshrikeParticipants wear the smartwatch throughout the day for 18 months other than when the smartwatch needs to be removed for charging or if the sensors fail. The study participant will be asked to follow instructions on the watch to manage. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Be able to provide electronic or written informed consent and be able to effectively communicate and understand the study procedures, risks, and required activities.
- Age 40 to 79 years.
- Be willing to wear a smartwatch continuously for 18 months and comfortable with using wearable devices or other technologies that monitor their data over time.
- Established ASCVD or at an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as anyone of the following:
- Evidence of atherosclerotic CAD on CT or invasive coronary angiogram defined as a coronary artery stenosis ≥ 20% but <50% in the left main coronary artery or a stenosis ≥ 20% but <70% in any other major coronary artery.
Key exclusion criteria (11 listed)
- The 10-year ASCVD risk <7.5%.
- Elevated troponin at baseline.
- Cognitive impairment.
- Neurological disorders that would impair their ability to provide informed consent or adhere to study protocols.
- Metastatic cancer or active cancer undergoing chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone application AntshrikeAll participants will wear a smart watch that has an application Antshrike, which will collect demographic data, health history, lifestyle factors, and biobehavioral data for 18 months. | Device | Smartphone application Antshrike |
Primary outcome
Number of ASCVD events
Time frame: Baseline through 18 months
ASCVD events include myocardial infarction (MI), ischemic stroke/transient ischemic attack (TIA), CV death, or clinically driven arterial revascularization or hospitalization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Background: PubMed 30392584Turakhia MP, Desai M, Hedlin H, Rajmane A, Talati N, Ferris T, Desai S, Nag D, Patel M, Kowey P, Rumsfeld JS, Russo AM, Hills MT, Granger CB, Mahaffey KW, Perez MV. Rationale and design of a large-scale, app-based study to identify cardiac arrhythmias using a smartwatch: The Apple Heart Study. Am Heart J. 2019 Jan;207:66-75. doi: 10.1016/j.ahj.2018.09.002. Epub 2018 Sep 8.
- Background: PubMed 31722151Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183.
- Individual participant dataSharing planned: No. No. Individual participant data collected during this study will not be shared with other researchers outside Stanford's primary research team and the adjudication team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sandra Tsai, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone application Antshrike in people with Myocardial Infarction (MI) and Stroke, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ASCVD events (time frame: Baseline through 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07735338, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.