The Heartflow Coronary Disease Progression Evaluation Study

NCT04052256 | Unknown

• 1 other identifier: THRONE1
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Fractional flow reserve; Coronary computed tomography angiography; Computational fluid dynamics; Plaque characteristics

Outcome Measures

Primary Outcomes (1)

• Coronary atherosclerotic disease progression

  FFRCT

  2 years

Secondary Outcomes (2)

• Target lesion failure Target vessel failure

  3-5 years

• Any coronary revascularisation

  3-5 years

Study Arms (1)

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

Interventions

Coronary computed tomography angiography DIAGNOSTIC_TEST

Computational fluid dynamic model information derived from CT

Patients with intermediate coronary lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Jonathan A Leipsic, MD, PhD

  University of British Columbia

  STUDY CHAIR

Central Study Contacts

Nicolas van Mieghem, MD, PhD

CONTACT

00311070438894; n.vanmieghem@erasmusmc.nl

Admir Dedic, MD, PhD

CONTACT

00311070438894; a.dedic@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Interventional Cardiology

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 9, 2019
• Study Start: October 5, 2018
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)