Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2026-02-21 @ 10:34 AM
Study NCT ID:
NCT02810795
Status:
COMPLETED
Last Update Posted:
2020-12-11
First Post:
2016-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Stress Perfusion CT for Detection of Inducible Myocardial Ischemia
Sponsor:
Erasmus Medical Center
Organization:
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:
True
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?: