Ignite Creation Date:
2024-05-06 @ 11:18 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03481712
Status:
COMPLETED
Last Update Posted:
2021-01-20
First Post:
2018-01-25
Brief Title:
Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease 2
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease 2
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
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 2
Brief Summary:
In a cohort of symptomatic patients referred to coronary computed tomography angiography CCTA the investigators aim
1 To investigate and compare the diagnostic precision of Rubidium Positron Emission Tomography Rb PET and 3 Tesla Cardiac Magnetic Resonance imaging 3T CMRI in patients where CCTA does not exclude significant coronary artery disease CAD using invasive coronary angiography with fractional flow reserve ICA-FFR as reference standard
2 To evaluate the diagnostic precision of quantitative flow ratio QFR and ICA-FFR in patients where CCTA does not exclude significant CAD using Rb PET and 3T CMRI as reference standard
3 To show superiority for the CADScorSystem compared to the Diamond-Forrester score in detection of CAD with CCTA and ICA quantitative coronary angiography ICA-QCA as reference standard
4 To study the diagnostic accuracy of computed tomography fractional flow reserve CT-FFR in patients where CCTA does not exclude significant CAD with ICA-FFR as reference standard
5 To identify and characterize genetic risk variants and circulating biomarkers importance in developing CAD
6 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 3 Tesla Cardiac Magnetic Resonance imaging 3T CMRI in patients where CCTA does not exclude significant coronary artery disease CAD using invasive coronary angiography with fractional flow reserve ICA-FFR as reference standard
2 To evaluate the diagnostic precision of quantitative flow ratio QFR and ICA-FFR in patients where CCTA does not exclude significant CAD using Rb PET and 3T CMRI as reference standard
3 To show superiority for the CADScorSystem compared to the Diamond-Forrester score in detection of CAD with CCTA and ICA quantitative coronary angiography ICA-QCA as reference standard
4 To study the diagnostic accuracy of computed tomography fractional flow reserve CT-FFR in patients where CCTA does not exclude significant CAD with ICA-FFR as reference standard
5 To identify and characterize genetic risk variants and circulating biomarkers importance in developing CAD
6 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 In Dan-NICAD 2 we intend to investigate the diagnostic accuracy of advanced non-invasive myocardial perfusion imaging tests Rb PET and 3T CMRI 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
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 CT-FFR has not been head to head compared against Rb PET and 3T CMRI
Obtained during ICA 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 ICA-QCA diameter stenosis However disagreement between FFR and QFR has been identified in up to 20 of all measurements
Acoustic detections of coronary stenosis from automatically recorded and analyzed heart sounds is a newly developed technology potentially useful for pre-test risk stratification before eg CCTA One of these devices the CADScorSystem has previously shown an area under the receiver operating characteristic curve AUC of ROC of 70-80 compared to conventional ICA-QCA This indicates that the CADScorSystem could potentially supplement clinical assessment of CAD and be used for risk stratification prior to CCTA
The investigators aim to obtain blood samples for biobank purposes and record heart sounds with the CADScorSystem in 2000 patients that by clinical evaluation undergo CCTA In approximately 400 patients 20 CCTA does not exclude significant CAD These patients are all examined using Rb PET 3T CMRI and ICA with QCA In patients with a coronary diameter stenosis of 30-90 determined during the ICA examination FFR coronary flow reserve CFR and QFR is performed
In patients with suspicion of coronary stenosis detected by CCTA current guidelines recommend verification of myocardial ischemia In Dan-NICAD 2 we intend to investigate the diagnostic accuracy of advanced non-invasive myocardial perfusion imaging tests Rb PET and 3T CMRI 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
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 CT-FFR has not been head to head compared against Rb PET and 3T CMRI
Obtained during ICA 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 ICA-QCA diameter stenosis However disagreement between FFR and QFR has been identified in up to 20 of all measurements
Acoustic detections of coronary stenosis from automatically recorded and analyzed heart sounds is a newly developed technology potentially useful for pre-test risk stratification before eg CCTA One of these devices the CADScorSystem has previously shown an area under the receiver operating characteristic curve AUC of ROC of 70-80 compared to conventional ICA-QCA This indicates that the CADScorSystem could potentially supplement clinical assessment of CAD and be used for risk stratification prior to CCTA
The investigators aim to obtain blood samples for biobank purposes and record heart sounds with the CADScorSystem in 2000 patients that by clinical evaluation undergo CCTA In approximately 400 patients 20 CCTA does not exclude significant CAD These patients are all examined using Rb PET 3T CMRI and ICA with QCA In patients with a coronary diameter stenosis of 30-90 determined during the ICA examination FFR coronary flow reserve CFR and QFR is performed
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