Clinical trial NCT04052256: The Heartflow Coronary Disease Progression Evaluation Study
Official title: The Heartflow Coronary Disease Progression Evaluation Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: Fractional flow reserve
Coronary computed tomography angiography
Computational fluid dynamics
Plaque characteristics
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Coronary atherosclerotic disease progression
timeFrame: 2 years
Secondary outcomes:
measure: Target lesion failure Target vessel failure
timeFrame: 3-5 years
measure: Any coronary revascularisation
timeFrame: 3-5 years
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: University of British Columbia
name: Jonathan A Leipsic, MD, PhD
role: STUDY_CHAIR
References: