Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02810795
Recruitment Status : Recruiting
First Posted : June 23, 2016
Last Update Posted : July 22, 2020
Sponsor:
Collaborators:
University Hospital Tuebingen
Siemens Medical Solutions
Bayer
University of Erlangen-Nürnberg
University Medical Center Groningen
Mie University
University Hospital, Zürich
Queen Mary University of London
University Hospital Munich
Information provided by (Responsible Party):
Trialbureau radiology, Erasmus Medical Center

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.

Condition or disease Intervention/treatment
Coronary Artery Disease Other: Diagnostic detection of coronary artery disease

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

Layout table for study information
Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dynamic Stress Perfusion ct for Detection of Inducible Myocardial Ischemia
Actual Study Start Date : June 7, 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Diagnostic detection of coronary artery disease
    Myocardial perfusion defect on dynamic CT perfusion imaging, and diagnostic accuracy as compared invasive FFR.


Primary Outcome Measures :
  1. Myocardial perfusion [ Time Frame: For each patient within 4 weeks of the CT perfusion acquisition ]
    invasive fractional flow reserve measurement


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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with know or suspect coronary artery diseased, referred for invasive coronary angiography.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810795


Contacts
Layout table for location contacts
Contact: Laurens Groenendijk 31 10 7033612 l.groenendijk@erasmusmc.nl
Contact: Koen Nieman 31 10 7033612 k.nieman@erasmusmc.nl

Locations
Layout table for location information
Netherlands
ErasmusMC Recruiting
Rotterdam, Zuid Holland, Netherlands, 3015CE
Sponsors and Collaborators
Erasmus Medical Center
University Hospital Tuebingen
Siemens Medical Solutions
Bayer
University of Erlangen-Nürnberg
University Medical Center Groningen
Mie University
University Hospital, Zürich
Queen Mary University of London
University Hospital Munich
Investigators
Layout table for investigator information
Principal Investigator: Koen Nieman, MD PHD Erasmus Medical Center
Layout table for additonal information
Responsible Party: Trialbureau radiology, Dr. K. Nieman MD, PHD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT02810795    
Other Study ID Numbers: SPECIFIC
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Trialbureau radiology, Erasmus Medical Center:
Coronary
Artery
Computed tomography
FFR
CT myocardial perfusion
Dynamic
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes