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The PRECISE Protocol: Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization

NCT03702244 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2103

Last updated 2023-12-29

Study results available
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Summary

The study will be a prospective, pragmatic, randomized clinical trial of the comparative effectiveness of diagnostic evaluation strategies for stable CAD, to be performed in outpatient settings, including primary care and cardiology practices.

Conditions

Interventions

DIAGNOSTIC_TEST

cCTA with selective FFRct

PRECISE will evaluate whether a precision evaluation strategy that combines contemporary risk stratification using the PROMISE Risk Tool with functional and anatomic non-invasive evaluation with cCTA with selective FFRct can improve outcomes over usual care in stable chest pain patients while safely deferring further testing in low-risk patients and reducing cost overall

Sponsors & Collaborators

  • Duke Clinical Research Institute

    collaborator OTHER

  • Cardiovascular Research Foundation, New York

    collaborator OTHER

  • HeartFlow, Inc.

    lead INDUSTRY

Principal Investigators

  • Pamela S Douglas · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-27
Primary Completion
2022-05-20
Completion
2022-05-20
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03702244 on ClinicalTrials.gov