Smartphone Application to PREDICT Real-Time Cardiovascular Risk for Heart Attack and Stroke (PREDICT-HS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Myocardial Infarction (MI)
• Intervention / Treatment: Device: Smartphone application Antshrike

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University
      • Contact: Sandra Tsai, MD; Phone Number: 650-498-9000; Email: stsai1@stanford.edu
      • Principal Investigator: Sandra Tsai, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Be able to provide electronic or written informed consent and be able to effectively communicate and understand the study procedures, risks, and required activities.
2. Age 40 to 79 years.
3. 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.
4. Established ASCVD or at an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as anyone of the following:

i) 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.

ii) Coronary artery calcium score ≥ 100 Agatston units.

iii) High estimated10-year ASCVD risk ≥ 20% by pooled cohort equation.

iv) Intermediate estimated 10-year ASCVD risk 7.5% to <20% by pooled cohort equation with at least 2 of the following risk-enhancing factors:

1. A first degree relative with history of premature ASCVD (males, age <55 years; females, age <65 years).
2. History of premature menopause before age 40.
3. History of maternal pregnancy complications (defined as a history of either preeclampsia, gestational hypertension, or gestational diabetes).
4. South Asian ancestry.
5. 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).
6. 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.
7. Lipoprotein (a) ≥50 mg/dL or ≥125 nmol/L at any time before the screening visit.
8. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2.
9. Ankle branchial index (ABI) <0.9 with no symptoms of intermittent claudication.
10. Metabolic syndrome: increased waist circumference, elevated triglycerides, elevated blood pressure, elevated glucose, and low HDL-C are factors

i. Diabetes

Exclusion Criteria:

1. The 10-year ASCVD risk <7.5%.
2. Elevated troponin at baseline.
3. Cognitive impairment.
4. Neurological disorders that would impair their ability to provide informed consent or adhere to study protocols.
5. Metastatic cancer or active cancer undergoing chemotherapy.
6. Terminal illness.
7. Pregnant women or women of childbearing potential not using contraception.
8. Current or past major psychiatric disorders (e.g., schizophrenia, bipolar disorder, severe depression) that could affect physiological or biometric data.
9. 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.
10. Unwillingness or inability to comply with study procedures, including adherence to study visits, fasting blood draws and compliance with study protocol.
11. Residing in an inpatient facility or bedbound

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Smartphone application Antshrike; 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.	Device: Smartphone application Antshrike; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline through 18 months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Before Health Intelligence Ltd; Samsung Electronics Co., Ltd
• Investigators: Principal Investigator: Sandra Tsai, MD, Stanford University

Publications and helpful links

General Publications

• Perez 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030

Study Registration Dates

• First Submitted: July 24, 2026
• First Submitted That Met QC Criteria: July 24, 2026
• First Posted (Actual): July 30, 2026

Study Record Updates

• Last Update Posted (Actual): July 30, 2026
• Last Update Submitted That Met QC Criteria: July 24, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Stroke; Myocardial Infarction
• Other Study ID Numbers: 86331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No