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

NCT07735338 | Not Yet Recruiting FDA Device

• 1 other identifier: 86331
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Device: Smartphone application Antshrike

Interventions

Smartphone application Antshrike DEVICE

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.

Smartphone application Antshrike

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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:
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Stanford University: lead
• Before Health Intelligence Ltd: collaborator
• Samsung Electronics Co., Ltd: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (2)

• 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.

  PMID: 30392584 BACKGROUND

• 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.

  PMID: 31722151 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction; Stroke

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sandra Tsai, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor in Medicine

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)