The Heartflow Coronary Disease Progression Evaluation Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04052256

Acronym

THRONE

Enrollment

250

Registered

2019-08-09

Start date

2018-10-05

Completion date

2023-10-01

Last updated

2022-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Fractional flow reserve, Coronary computed tomography angiography, Computational fluid dynamics, Plaque characteristics

Brief 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.

Interventions

DIAGNOSTIC_TESTCoronary computed tomography angiography

Computational fluid dynamic model information derived from CT

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients (age ≥ 18 years) treated with PCI (for non-ST elevation myocardial infarction, unstable or stable angina and silent ischemia) or who undergo invasive FFR. 2. Minimum of one non-treated coronary artery with an intermediate lesion and invasive FFR 0.81-0.90 to serve as the target vessel for FFRCT.

Exclusion criteria

1. ST elevation myocardial infarction. 2. Previous CABG. 3. Target vessel for FFR measurement \< 2.0 mm in diameter. 4. Contraindications to contrast agents, beta-blocking agents, nitroglycerin or adenosine. 5. Life expectancy less than 3 years. 6. Creatinine clearance \< 30 ml/min\*1.73m2.

Design outcomes

Primary

Measure	Time frame	Description
Coronary atherosclerotic disease progression	2 years	FFRCT

Secondary

Measure	Time frame	Description
Target lesion failure Target vessel failure	3-5 years	Composite of all-cause mortality, target-vessel myocardial infarction and cinically driven target vessel revascularization.
Any coronary revascularisation	3-5 years	—

Countries

Netherlands

Contacts

Primary ContactNicolas van Mieghem, MD, PhD

n.vanmieghem@erasmusmc.nl00311070438894

Backup ContactAdmir Dedic, MD, PhD

a.dedic@erasmusmc.nl00311070438894

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026