Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04707859
Status:
UNKNOWN
Last Update Posted:
2021-01-29
First Post:
2021-01-11
Brief Title:
Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease 3
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease 3
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Dan-NICAD 3
Brief Summary:
In a cohort of symptomatic patients referred to coronary computed tomography angiography CCTA the investigators aim is
1 To investigate and compare the diagnostic precision of Rubidium Positron Emission Tomography Rb PET and 15O-water PET 15O-water PET in patients where CCTA does not exclude obstructive coronary artery disease CAD using invasive coronary angiography with fractional flow reserve ICA-FFR as reference standard
2 To study the diagnostic accuracy and prognostic value of computed tomography fractional flow reserve CT-FFR in patients where CCTA does not exclude obstructive CAD with ICA-FFR as reference standard
3 To validated a pre-test probability model including genetic and circulating biomarkers
4 To identify and characterize genetic risk variants and circulating biomarkers importance in developing CAD
5 To evaluate the bone mineral density in the hip and spine and correlate this to the degree of vascular calcification
1 To investigate and compare the diagnostic precision of Rubidium Positron Emission Tomography Rb PET and 15O-water PET 15O-water PET in patients where CCTA does not exclude obstructive coronary artery disease CAD using invasive coronary angiography with fractional flow reserve ICA-FFR as reference standard
2 To study the diagnostic accuracy and prognostic value of computed tomography fractional flow reserve CT-FFR in patients where CCTA does not exclude obstructive CAD with ICA-FFR as reference standard
3 To validated a pre-test probability model including genetic and circulating biomarkers
4 To identify and characterize genetic risk variants and circulating biomarkers importance in developing CAD
5 To evaluate the bone mineral density in the hip and spine and correlate this to the degree of vascular calcification
Detailed Description:
CCTA has become the preferred diagnostic modality for symptomatic patients with low to intermediate risk of CAD Of the patients examined CCTA exclude cardiovascular disease in 70-80 with an excellent negative predictive value of more than 95 Having a low positive predictive value however CCTA often overestimates the severity of CAD especially in patients with moderate to severe coronary calcification Following CCTA patients are hence unnecessarily tested using golden standard ICA-FFR These ICAs often show no obstructive coronary stenosis and are therefore not followed by revascularization The issues outlined raises the question of whether it is possible 1 to make a more precise risk stratification and consequently better selection of patients prior to CCTA and 2 to reduce the number of patients referred for unnecessary ICAs following CCTA
In patients with suspicion of coronary stenosis detected by CCTA current guidelines recommend verification of myocardial ischemia Dan-NICAD 3 investigate the diagnostic accuracy of advanced non-invasive myocardial perfusion imaging tests Rb PET and 15O-water PET These examinations have shown a high diagnostic accuracy in symptomatic patients with high risk of ischemic heart disease However the diagnostic accuracy is not investigated in patients as follow-up after CCTA In addition microcirculation may impact the correlation between PET and ICA-FFR which this study will investigate further
An alternative way to increase the diagnostic accuracy of CCTA and thus avoid unnecessary downstream testing using ICA is to utilize the ability to extract physiological information from the anatomical CCTA images CT-FFR has in previous studies shown promising results In addition calculated estimation of microcirculatiory function is under development and this study will validated these algorithms Furthermore the prognostic value of CT-FFR is unknown and will be tested in the pooled cohort of Dan-NICAD 1 2 and 3
Obtained during ICA quantitative flow ratio QFR is a novel wire-free approach for fast computation of FFR with potential to increase the global use of physiological lesion assessment QFR is superior to traditional assessment of intermediate coronary lesions based on quantitative coronary analysis of ICA However disagreement between ICA-FFR and QFR has been identified in up to 20 of all measurements QFR will be validated compared to PET and ICA-FFR
In patients with suspicion of coronary stenosis detected by CCTA current guidelines recommend verification of myocardial ischemia Dan-NICAD 3 investigate the diagnostic accuracy of advanced non-invasive myocardial perfusion imaging tests Rb PET and 15O-water PET These examinations have shown a high diagnostic accuracy in symptomatic patients with high risk of ischemic heart disease However the diagnostic accuracy is not investigated in patients as follow-up after CCTA In addition microcirculation may impact the correlation between PET and ICA-FFR which this study will investigate further
An alternative way to increase the diagnostic accuracy of CCTA and thus avoid unnecessary downstream testing using ICA is to utilize the ability to extract physiological information from the anatomical CCTA images CT-FFR has in previous studies shown promising results In addition calculated estimation of microcirculatiory function is under development and this study will validated these algorithms Furthermore the prognostic value of CT-FFR is unknown and will be tested in the pooled cohort of Dan-NICAD 1 2 and 3
Obtained during ICA quantitative flow ratio QFR is a novel wire-free approach for fast computation of FFR with potential to increase the global use of physiological lesion assessment QFR is superior to traditional assessment of intermediate coronary lesions based on quantitative coronary analysis of ICA However disagreement between ICA-FFR and QFR has been identified in up to 20 of all measurements QFR will be validated compared to PET and ICA-FFR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None