Dynamic Stress Perfusion CT for Detection of Inducible Myocardial Ischemia (SPECIFIC)

December 10, 2020 updated by: Trialbureau radiology, Erasmus Medical Center

Dynamic Stress Perfusion ct for Detection of Inducible Myocardial Ischemia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Zuid Holland
      • Rotterdam, Zuid Holland, Netherlands, 3015CE
        • ErasmusMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with know or suspect coronary artery diseased, referred for invasive coronary angiography.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial perfusion
Time Frame: For each patient within 4 weeks of the CT perfusion acquisition
invasive fractional flow reserve measurement
For each patient within 4 weeks of the CT perfusion acquisition

Secondary Outcome Measures

Outcome Measure
Time Frame
Presence of myocardial perfusion defect on MPIMRI
Time Frame: For each patient within 1 week before invasive fractional flow reserve measurement
For each patient within 1 week before invasive fractional flow reserve measurement
Per patient assessment of hemodynamically significant CAD
Time Frame: For each patient within 4 weeks of the CT perfusion acquisition
For each patient within 4 weeks of the CT perfusion acquisition
Ischemia per standardized myocardial segment
Time Frame: For each patient within 4 weeks of the CT perfusion acquisition
For each patient within 4 weeks of the CT perfusion acquisition
Coronary stenosis by CTA per territory (branch)
Time Frame: For each patient within 4 weeks of the CT perfusion acquisition
For each patient within 4 weeks of the CT perfusion acquisition
Coronary stenosis by invasive angiography per territory (branch)
Time Frame: For each patient within 4 weeks of the CT perfusion acquisition
For each patient within 4 weeks of the CT perfusion acquisition
Demographics.
Time Frame: For each patient within 1 week before invasive fractional flow reserve measurement
For each patient within 1 week before invasive fractional flow reserve measurement
Cardiovascular risk factors
Time Frame: For each patient within 1 week before invasive fractional flow reserve measurement
For each patient within 1 week before invasive fractional flow reserve measurement
'Image quality, based on the DICOM images measured by experienced readers."
Time Frame: Through study completion, an average of 1 to 2 years
Through study completion, an average of 1 to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Collaborators

Bayer
University Medical Center Groningen
University of Erlangen-Nürnberg
Queen Mary University of London
Siemens Medical Solutions
University Hospital Tuebingen
University Hospital, Zürich
University Hospital Munich
Mie University

Investigators

  • Principal Investigator: Koen Nieman, MD PHD, Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 7, 2016

Primary Completion (ACTUAL)

December 10, 2020

Study Completion (ACTUAL)

December 10, 2020

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (ESTIMATE)

June 23, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 11, 2020

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPECIFIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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