The Heartflow Coronary Disease Progression Evaluation Study

• Conditions: Coronary Artery Disease
• Interventions: Diagnostic Test: Coronary computed tomography angiography

• Registration Number: NCT04052256
• Lead Sponsor: Erasmus Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-05
• Study First Submitted: 2019-08-08
• Study First Submitted QC: 2019-08-08
• Study First Posted: 2019-08-09
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-27
• Primary Completion: 2022-10
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with intermediate coronary lesions	Coronary computed tomography angiography	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.

Primary Outcome Measures

Name	Time	Method
Coronary atherosclerotic disease progression	2 years	FFRCT

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Erasmus MC; 🇳🇱 Rotterdam, Netherlands