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The Heartflow Coronary Disease Progression Evaluation Study

NCT04052256 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2022-07-27

No results posted yet for this study

Summary

Invasively measured fractional flow reserve (FFR) has proven to be useful in guiding coronary revascularization. Several studies have shown that it is justified to treat lesions with a value of 0.80 or lower and safe to defer from PCI in lesions with a value of \>0.80. Recently, computational fluid dynamics have allowed FFR measurement from coronary computed tomography angiography images (FFRCT) with excellent diagnostic accuracy compared to invasive FFR.

FFRCT can also effectively guide revascularization safely deferring patient with FFRCT \>0.80 from invasive angiography. In functionally non-significant lesions, computational fluid dynamic models in addition to CT plaque characteristics (low attenuation, positive remodelling, spotty calcification and napkin-ring sign) may be able to predict which lesions will become flow-limiting, causing clinical events in the future.

This study will evaluate disease progression in intermediate lesions (invasive FFR 0.81-0.90 at baseline) using FFRCT at 2 years and determine whether CT characteristics may help to identify lesions that are more susceptible for FFR decline. Additionally, we will correlate CT characteristics with coronary events (a composite endpoint consisting of all-cause mortality, target-vessel myocardial infarction and clinically driven target-vessel revascularization) up to 5 years after the baseline invasive FFR.

Conditions

Interventions

DIAGNOSTIC_TEST

Coronary computed tomography angiography

Computational fluid dynamic model information derived from CT

Sponsors & Collaborators

Principal Investigators

  • Jonathan A Leipsic, MD, PhD · University of British Columbia

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-05
Primary Completion
2022-10-31
Completion
2023-10-01

Countries

  • Netherlands

Study Locations

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Diseases
Companies

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 NCT04052256 on ClinicalTrials.gov