Ignite Creation Date:
2024-05-06 @ 8:45 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02810795
Status:
COMPLETED
Last Update Posted:
2020-12-11
First Post:
2016-06-07
Brief Title:
Dynamic Stress Perfusion CT for Detection of Inducible Myocardial Ischemia
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Dynamic Stress Perfusion ct for Detection of Inducible Myocardial Ischemia
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:
SPECIFIC
Brief Summary:
The purpose of this study is to determine the diagnostic accuracy of MPICT for the detection of hemodynamically relevant coronary stenosis as determined by invasive FFR in patients with suspected or known CAD clinically referred for invasive angiography
Detailed Description:
Rationale Cardiac computed tomography CT provides accurate assessment of the coronary arteries and detects significant coronary stenosis with high diagnostic accuracy However the hemodynamic relevance of these stenotic lesion remains unclear although highly relevant for clinical decision-making Recent technical developments with third-generation dual-source CT allow to determine myocardial perfusion during hyperemia and thus for assessment of the hemodynamic relevance of coronary lesions using a dynamic acquisition mode To date there is only very limited evidence of the feasibility of this approach stemming from single-center studies with varying standards of reference
Objective To determine the diagnostic accuracy of MPICT for the detection of hemodynamically relevant coronary stenosis as determined by invasive FFR in patients with suspected or known CAD clinically referred for invasive angiography In an optional sub-study the diagnostic accuracy of MPICT for the detection of myocardial perfusion defects as determined by cardiac magnetic resonance imaging CMRI will be investigated
Study design Observational cohort study with fractional flow reserve FFR during invasive angiography as the reference standard
Study population Patients with known or suspected CAD clinically referred for invasive angiography
Main study parameters Myocardial perfusion defect on dynamic CT perfusion imaging and diagnostic accuracy as compared invasive FFR
Co Principle Investigators Koen Nieman MD PhD Erasmus University Medical Center Fabian Bamberg MD PhD University of Tübingen
Investigators Valerie Schmidt-Honndorf PhD University of Tübingen Tobias Geisler MD PhD University of Tübingen Joost Daemen MD PhD Erasmus University Medical Center Adriaan Coenen MD Erasmus University Medical Center Stephan Achenbach MD PhD Erlangen University Micheala M Hell MD Erlangen University Rozemarijn Vliegenthart MD PhD UMC Groningen Pim van der Harst MD PhD UMC Groningen Francesca Pugliese MD PhD Queen Mary University of London Kakuya Kitagawa MD PhD Mie University Hatem Alkadhi MD PhD University Hospital Zurich Switzerland Robert Manka MD PhD University Hospital Zurich Switzerland
Objective To determine the diagnostic accuracy of MPICT for the detection of hemodynamically relevant coronary stenosis as determined by invasive FFR in patients with suspected or known CAD clinically referred for invasive angiography In an optional sub-study the diagnostic accuracy of MPICT for the detection of myocardial perfusion defects as determined by cardiac magnetic resonance imaging CMRI will be investigated
Study design Observational cohort study with fractional flow reserve FFR during invasive angiography as the reference standard
Study population Patients with known or suspected CAD clinically referred for invasive angiography
Main study parameters Myocardial perfusion defect on dynamic CT perfusion imaging and diagnostic accuracy as compared invasive FFR
Co Principle Investigators Koen Nieman MD PhD Erasmus University Medical Center Fabian Bamberg MD PhD University of Tübingen
Investigators Valerie Schmidt-Honndorf PhD University of Tübingen Tobias Geisler MD PhD University of Tübingen Joost Daemen MD PhD Erasmus University Medical Center Adriaan Coenen MD Erasmus University Medical Center Stephan Achenbach MD PhD Erlangen University Micheala M Hell MD Erlangen University Rozemarijn Vliegenthart MD PhD UMC Groningen Pim van der Harst MD PhD UMC Groningen Francesca Pugliese MD PhD Queen Mary University of London Kakuya Kitagawa MD PhD Mie University Hatem Alkadhi MD PhD University Hospital Zurich Switzerland Robert Manka MD PhD University Hospital Zurich Switzerland
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None