THRONE: The Heartflow Coronary Disease Progression Evaluation Study

Sponsor

Erasmus Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04052256

Collaborator

(none)

250

Enrollment

Location

59.9

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Diagnostic Test: Coronary computed tomography angiography

Study Design

Study Type:

Observational

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Heartflow Coronary Disease Progression Evaluation Study

Actual Study Start Date :

Oct 5, 2018

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients with intermediate coronary lesions Patients (age ≥ 18 years) who have undergone invasive coronary angiography and have a minimum of one non-treated coronary artery with a measured invasive FFR of 0.81-0.90.	Diagnostic Test: Coronary computed tomography angiography Computational fluid dynamic model information derived from CT

Arm

Intervention/Treatment

Patients with intermediate coronary lesions

Patients (age ≥ 18 years) who have undergone invasive coronary angiography and have a minimum of one non-treated coronary artery with a measured invasive FFR of 0.81-0.90.

Diagnostic Test: Coronary computed tomography angiography

Computational fluid dynamic model information derived from CT

Outcome Measures

Primary Outcome Measures

Coronary atherosclerotic disease progression [2 years]
FFRCT

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
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:

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