Dynamic Stress Perfusion CT for Detection of Inducible Myocardial Ischemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-07

Study Completion Date

2020-12-10

Brief Summary

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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

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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

Conditions

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Coronary Artery Disease

Keywords

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Coronary Artery Computed tomography FFR CT myocardial perfusion Dynamic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Diagnostic detection of coronary artery disease

Myocardial perfusion defect on dynamic CT perfusion imaging, and diagnostic accuracy as compared invasive FFR.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 21-75 years
* Stable angina symptoms, suspected or known CAD, and referred for invasive angiography on clinical grounds.
* Ability to provide informed consent
* Ability to perform a 20-30 second breath hold

Exclusion Criteria

* Hemodynamically and clinically unstable condition (angina at rest, malignant arrhythmias)
* Prior, documented myocardial infarction, other than (procedure related) minor type II myocardial infarction, which includes Q waves on the ECG or evidence of myocardial infarction on prior non-invasive imaging.
* Prior stenting or coronary artery bypass graft surgery
* Significant other cardiovascular conditions affecting the interpretation of MPICT, including, but not limited to: clinical heart failure, IECD (pacemaker/ICD), severe valvular heart disease or prosthetic valves, significant intra-cardiac shunting or other relevant congenital heart disease.
* eGFR\<60 ml/kg/min
* BMI\>30 kg/m2, or weight \>120 kg.
* Atrial fibrillation or other arrhythmia, \>6 ectopic beats / min
* Known or suspected allergy to iodinated contrast medium
* Pregnancy cannot be excluded
* Contra-indications for adenosine: bronchial asthma, second or third degree atrioventricular block, blood pressure \<110/70 mmHg, allergies or severe side effects in the past.

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Trialbureau radiology

Dr. K. Nieman MD, PHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Koen Nieman, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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ErasmusMC

Rotterdam, South Holland, Netherlands

Site Status

Countries

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Netherlands

References

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Soschynski M, Storelli R, Birkemeyer C, Hagar MT, Faby S, Schwemmer C, Nous FMA, Pugliese F, Vliegenthart R, Schlett CL, Nikolaou K, Krumm P, Nieman K, Bamberg F, Artzner CP. CT Myocardial Perfusion and CT-FFR versus Invasive FFR for Hemodynamic Relevance of Coronary Artery Disease. Radiology. 2024 Aug;312(2):e233234. doi: 10.1148/radiol.233234.

Reference Type DERIVED

PMID: 39162632 (View on PubMed)

Nous FMA, Geisler T, Kruk MBP, Alkadhi H, Kitagawa K, Vliegenthart R, Hell MM, Hausleiter J, Nguyen PK, Budde RPJ, Nikolaou K, Kepka C, Manka R, Sakuma H, Malik SB, Coenen A, Zijlstra F, Klotz E, van der Harst P, Artzner C, Dedic A, Pugliese F, Bamberg F, Nieman K. Dynamic Myocardial Perfusion CT for the Detection of Hemodynamically Significant Coronary Artery Disease. JACC Cardiovasc Imaging. 2022 Jan;15(1):75-87. doi: 10.1016/j.jcmg.2021.07.021. Epub 2021 Sep 15.

Reference Type DERIVED

PMID: 34538630 (View on PubMed)

Other Identifiers

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SPECIFIC

Identifier Type: -

Identifier Source: org_study_id