REFINE-CAC Protocol: Risk Evaluation With AI-CPA + HCS For Patients IN Whom Calcium is confirmEd to Improve Coronary Artery Disease Care

Part of paid clinical trials in New York, New York.

Sponsor
HeartFlow, Inc.
Study ID
NCT07853716
Status
Not Yet Recruiting

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Conditions

  • CAD - Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
40 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Heartflow Analysis — DEVICE
    REFINE-CAC will provide Heartflow Analyses

Study Details

REFINE-CAC is a prospective, multi-center trial assessing the management of asymptomatic participants with CAC scores 1-299 Agatston units or incidental CAC findings on chest computed tomography (CT), all of whom will undergo CCTA and are blinded to the coronary anatomy (e.g., % stenosis). The trial includes a randomized, controlled pathway and a single arm, observational registry pathway.

Key Dates

First listed
Oct 2, 2026
Start date
Nov 30, 2026
Status verified
Sep 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Usual Care Arm
  • Experimental: Unblinded Test Arm
  • Other: Unblinded Registry Arm

Primary Outcome Measure

Percentage of participants who initiate, intensify, cease, or de-escalate lipid lowering therapy (LLT) [ Time Frame: Enrollment to 90 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
REFINE-CAC Trial SiteNew YorkNew York10005
Heartflow Investigator
[email protected]
8774783569

Find similar trials in New York, NY

By research site
REFINE-CAC Trial Site· New York, NY

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