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The Heartflow Coronary Disease Progression Evaluation Study (THRONE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04052256
Recruitment Status : Recruiting
First Posted : August 9, 2019
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Nicolas van Mieghem, 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.


Condition or disease Intervention/treatment
Coronary Artery Disease Diagnostic Test: Coronary computed tomography angiography

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Coronary atherosclerotic disease progression [ Time Frame: 2 years ]
    FFRCT


Secondary Outcome Measures :
  1. 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.

  2. Any coronary revascularisation [ Time Frame: 3-5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Nicolas van Mieghem, MD, PhD 00311070438894 n.vanmieghem@erasmusmc.nl
Contact: Admir Dedic, MD, PhD 00311070438894 a.dedic@erasmusmc.nl

Locations
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Netherlands
Erasmus MC Recruiting
Rotterdam, Netherlands
Contact: Admir Dedic, MD, PhD    00311070438894    a.dedic@erasmusmc.nl   
Principal Investigator: Nicolas van Mieghem, MD, PhD         
Sub-Investigator: Admir Dedic, MD, PhD         
Sponsors and Collaborators
Erasmus Medical Center
Investigators
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Study Chair: Jonathan A Leipsic, MD, PhD University of British Columbia

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Responsible Party: Nicolas van Mieghem, Director of Interventional Cardiology, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT04052256    
Other Study ID Numbers: THRONE1
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nicolas van Mieghem, Erasmus Medical Center:
Fractional flow reserve
Coronary computed tomography angiography
Computational fluid dynamics
Plaque characteristics
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Disease Progression
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Disease Attributes
Pathologic Processes