OCORO Heart Study
A new standard for
cardiovascular research.
The OCORO Heart Study aims to bridge the data insight gap surrounding the world’s leading cause of death.
The Problem
A leading killer,
seen only in snapshots.
Cardiovascular disease kills more people globally than anything else. But the evidence informing how we treat it comes from brief clinic visit months apart and data fragmented across visits.
#1
cause of death globally, cardiovascular disease (CVD) has been the world’s leading killer for more than two decades
Global deaths by cause (2021)
1 in 3
global deaths each year are caused by cardiovascular disease
The data gap
~89%
of atrial fibrillation cases missed by standard cardiac monitoring over three years versus continuous capture
The time cost
~4/yr
in-person visits asked of stable heart-failure patients each year. Each visit costs travel, time off work, and clinic time, usually for a routine check-in.
A longitudinal view of cardiovascular health.
The OCORO Heart Study is a decentralized, observational cardiovascular research study using multi-modal data capture from medical grade wearables, connected devices, electronic health records (EHR), clinical labs, and electronic patient-reported outcomes (ePRO). The real-world data will help researchers understand how cardiovascular disease evolves in daily life, even spanning different diagnoses.
Prolaio sponsors and manages the OCORO Heart Study.
In collaboration with
The COHORT
Who’s in the study?
OCORO follows U.S. adults with diagnosed cardiovascular conditions. Patients may be referred by clinicians or self-enroll, and are able to continue their usual care.
Enrolling
Patient Cohort
Eligibility
- Adults (18+) living in the U.S. (all 50 states)
- Diagnosed cardiovascular condition (cardiomyopathy, arrhythmia, heart failure, hypertension, valve disease)
-
45+
Clinical subtypes
included -
38
States
represented -
59
Median
age -
69%
Female
Study Design
How the study works.
From consent to continuous data capture, each step is designed to fit in a participant’s daily life.
Screen & Consent
Online eligibility check + electronic informed consent, completed from home.
Kit Delivery
All devices shipped to participant’s door at no cost. Setup in ~20 minutes.
Multi-Modal Data Collection & Analysis
Data collected from at-home wearables, EHR, and ePRO are paired with predictive analytics.
Monthly Participant Summary Report
Participant receives a monthly participant summary report that they may choose to share with their doctor.
Longitudinal Follow-up
Participants continue for up to 5 years. Withdrawal is voluntary.
Study Methodology
What we’re learning.
How we measure it.
Continuous data is only useful if you know what to ask of it. OCORO is built around structured research aims and a portfolio of validated digital biomarkers—turning real-world signal into clinical-grade evidence.
Study Objectives
- Understand how heart disease changes over time. Use continuous, multi-stream data to characterize how disease progresses across patient cohorts.
- Detect transitions in disease state. Identify physiologic profiles that mark changes in disease severity or differentiate between cardiovascular conditions.
- Improve the study experience through direct patient feedback. Incorporate participant feedback to improve usability, engagement, and retention throughout the study.
Digital Biomarkers
- eVO2peak. A cardiorespiratory fitness biomarker derived from at-home wearable data, validated against gold-standard CPET.
- A growing portfolio of digital biomarkers. Prolaio has and continues to develop digital biomarkers from high-density, continuous wearable data, translating raw signal into validated clinical measures that researchers and clinicians can act on.
Data Collected from Study Devices
Cardiobracelet
- Heart Rate (HR)
- Peripheral Oxygen Saturation (SpO2)
- Respiratory Rate (RR)
- Heart Rate Variability (HRV)
- Activity
Blood Pressure Cuff
- Systolic Blood Pressure
- Diastolic Blood Pressure
- Resting Pulse Rate
ECG Patch
- Continuous ECG (electrocardiogram)
- Heart Rate Variability (HRV)
- Respiratory Rate (RR)
- Activity
Weight Scale
- Body weight
Additional Data Streams we connect to
EHR (Electronic Health Records)
- Conditions & Allergies
- Medications & Immunizations
- Vital Signs
- Demographics & Family
- Clinical & Procedure History
- Care Plans & Goals
Lab Results
- Cardiac biomarkers
- Lipid panel
- Metabolic & kidney function
- Glycemic markers
- Hematology
- Specimens
ePRO (electronic Patient-Reported Outcomes)
- Health goals
- Mental health & mood
- Symptom & Lifestyle diary
- Sleep self-report
- Medication adherence
- Quality of life & functional status
-
5K+
Participant target
-
6
Biomarker streams
-
7
FDA-regulated algorithms
-
Monthly
Participant summary reports
-
100%
Remote, no required clinic visits
Built for participants.
Trusted by researchers.
OCORO is designed to the highest standards of participant experience, data security, and scientific rigor.
The tools clinicians rely on shouldn’t stay locked in clinics. When everyone has access to the technology, research and care improves for everyone.
Dr. Greg Kurio
Cardiologist
Prolaio's Head of Developmental Services
Principal Investigator for OCORO
Heart failure runs in my family, so this felt like a way to support research that may benefit my kid’s generation.
Vinnie B.
Participant
OCORO Heart Study
My patients have found the system included in the OCORO study to be empowering and helpful to them.
Jeffrey B. Geske, MD
Cardiologist, Professor of Medicine
Mayo Clinic Rochester
IRB oversight
Overseen by an independent Institutional Review Board (IRB).
HIPAA & data security
Encrypted, HIPAA-compliant handling with a Part 11 audit trail.
Observational & voluntary
Observational only; no real-time health monitoring.
Listed on ClinicalTrials.gov
Registered as NCT07420907 on ClinicalTrials.gov.
Ways to engage with OCORO.
Whether you’re running a targeted analysis, referring a patient, or seeing if you’re eligible to join — there’s a path for you.
For patients
See if you're eligible
Check your eligibility and enroll in the OCORO Heart Study — at-home cardiovascular monitoring at no cost to you.
For clinicians
Refer a patient
Send a patient into the study with a one-form referral. The study team handles enrollment, devices, and follow-up.
For Partners
Discover disease insights
Work with the Prolaio team to generate insights or outcomes from the OCORO cohort — indication-specific research, regulatory submissions, or RWE programs.