The Heartflow Coronary Disease Progression Evaluation Study

Coronary Artery Disease Clinical Trial

— THRONE  

Official title:

The Heartflow Coronary Disease Progression Evaluation Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04052256
• Other study ID #: THRONE1
• Status: Recruiting
• Start date: October 5, 2018
• Est. completion date: October 1, 2023

Study information

• Verified date: July 2022
• Source: Erasmus Medical Center
• Contact: Nicolas van Mieghem, MD, PhD
• Phone: 00311070438894
• Email: n.vanmieghem[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: October 1, 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Disease Progression

Intervention

Diagnostic Test:
• Coronary computed tomography angiography
Computational fluid dynamic model information derived from CT

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary atherosclerotic disease progression	FFRCT	2 years
Secondary	Target lesion failure Target vessel failure	Composite of all-cause mortality, target-vessel myocardial infarction and cinically driven target vessel revascularization.	3-5 years
Secondary	Any coronary revascularisation		3-5 years