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AI DErived Plaque Quantification: CCTA and AI-QCPA for Determining Effective CAD Management

NCT06376851 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20000

Last updated 2025-10-14

No results posted yet for this study

Summary

The objective of HeartFlow's DECIDE Registry is to collect observational data about the management of patients before and after HeartFlow Artificial Intelligence-Quantitative Coronary Plaque Analysis (AI-QCPA).

Conditions

Interventions

DIAGNOSTIC_TEST

AI-enabled quantitative coronary plaque analysis (AI-QCPA)

The HeartFlow Plaque Analysis provides plaque identification, quantification, and characterization and is meant to support qualified clinicians to aid in the evaluation and risk assessment of coronary artery disease (CAD). It provides data on the volume and type of plaque present (Calcified, Non-calcified, Low Attenuation), both vessel specific and total volumes, with which physicians can better understand a patient's risk, discuss heart health, and help optimize medical management. Plaque Analysis is calculated using image data from a previously acquired CCTA.

Sponsors & Collaborators

  • HeartFlow, Inc.

    lead INDUSTRY

Principal Investigators

  • Sarah Rinehart, MD · CAMC Health System

  • Leslee Shaw, MD · MOUNT SINAI HOSPITAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-27
Primary Completion
2026-03-27
Completion
2030-03-27
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06376851 on ClinicalTrials.gov