The Heartflow Coronary Disease Progression Evaluation Study

Study Overview
=================
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.

Official Title
-----------------
The Heartflow Coronary Disease Progression Evaluation Study

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Coronary computed tomography angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with intermediate coronary lesions<br>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<br>* Computational fluid dynamic model information derived from CT<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary atherosclerotic disease progression | FFRCT | 2 years | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fractional flow reserve, Coronary computed tomography angiography, Computational fluid dynamics, Plaque characteristics