The Heartflow Coronary Disease Progression Evaluation Study (THRONE)
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|ClinicalTrials.gov Identifier: NCT04052256|
Recruitment Status : Recruiting
First Posted : August 9, 2019
Last Update Posted : September 30, 2019
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|
|Coronary Artery Disease||Diagnostic Test: Coronary computed tomography angiography|
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||The Heartflow Coronary Disease Progression Evaluation Study|
|Actual Study Start Date :||October 5, 2018|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2023|
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
- Coronary atherosclerotic disease progression [ Time Frame: 2 years ]FFRCT
- Target lesion failure Target vessel failure [ Time Frame: 3-5 years ]Composite of all-cause mortality, target-vessel myocardial infarction and cinically driven target vessel revascularization.
- Any coronary revascularisation [ Time Frame: 3-5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04052256
|Contact: Nicolas van Mieghem, MD, PhDemail@example.com|
|Contact: Admir Dedic, MD, PhDfirstname.lastname@example.org|
|Contact: Admir Dedic, MD, PhD 00311070438894 email@example.com|
|Principal Investigator: Nicolas van Mieghem, MD, PhD|
|Sub-Investigator: Admir Dedic, MD, PhD|
|Study Chair:||Jonathan A Leipsic, MD, PhD||University of British Columbia|