Coronary Artery DiseaseSPECIFICNCT02810795
Dynamic Stress Perfusion CT for Detection of Inducible Myocardial Ischemia
An observational study of Coronary Artery Disease, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Diagnostic detection of coronary artery disease
- How many people
- 180 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Jun 2016to 10 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with know or suspect coronary artery diseased, referred for invasive coronary angiography.
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Coronary Artery Disease
- Being tested
- Diagnostic detection of coronary artery disease
- Keywords
- Coronary, Artery, Computed tomography, FFR, CT myocardial perfusion, Dynamic
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic detection of coronary artery diseaseOther
Myocardial perfusion defect on dynamic CT perfusion imaging, and diagnostic accuracy as compared invasive FFR.
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial perfusion
invasive fractional flow reserve measurement
Measured: For each patient within 4 weeks of the CT perfusion acquisition
Secondary outcomes (8)
Presence of myocardial perfusion defect on MPIMRI
Measured: For each patient within 1 week before invasive fractional flow reserve measurement
Per patient assessment of hemodynamically significant CAD
Measured: For each patient within 4 weeks of the CT perfusion acquisition
Ischemia per standardized myocardial segment
Measured: For each patient within 4 weeks of the CT perfusion acquisition
Coronary stenosis by CTA per territory (branch)
Measured: For each patient within 4 weeks of the CT perfusion acquisition
Coronary stenosis by invasive angiography per territory (branch)
Measured: For each patient within 4 weeks of the CT perfusion acquisition
Demographics.
Measured: For each patient within 1 week before invasive fractional flow reserve measurement
Cardiovascular risk factors
Measured: For each patient within 1 week before invasive fractional flow reserve measurement
'Image quality, based on the DICOM images measured by experienced readers."
Measured: Through study completion, an average of 1 to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study start7 Jun 2016
- Primary completion10 Dec 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Trialbureau radiology, Erasmus Medical Center
- Investigators
- Koen Nieman, MD PHD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810795
- Sponsor's protocol ID
- SPECIFIC
- Acronym
- SPECIFIC
- Status last verified
- Dec 2020
- First submitted
- 7 Jun 2016
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 39162632Nous 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.
PubMed 34538630
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Stress Perfusion ct for Detection of Inducible Myocardial Ischemia
- ClinicalTrials.gov ID
- NCT02810795
- Acronym / sponsor ID
- SPECIFIC / SPECIFIC
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary, Artery, Computed tomography, FFR, CT myocardial perfusion, Dynamic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- 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
- Study start
- 7 Jun 2016 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with know or suspect coronary artery diseased, referred for invasive coronary angiography.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic detection of coronary artery diseaseMyocardial perfusion defect on dynamic CT perfusion imaging, and diagnostic accuracy as compared invasive FFR. | Other | – |
Primary outcome
Myocardial perfusion
Time frame: For each patient within 4 weeks of the CT perfusion acquisition
invasive fractional flow reserve measurement
8 secondary outcomes
Presence of myocardial perfusion defect on MPIMRI
Time frame: 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
Ischemia per standardized myocardial segment
Time frame: 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
Coronary stenosis by invasive angiography per territory (branch)
Time frame: 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
Cardiovascular risk factors
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Derived from this study: PubMed 39162632Soschynski 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.
- Derived from this study: PubMed 34538630Nous 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koen Nieman, MD PHD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial perfusion (time frame: For each patient within 4 weeks of the CT perfusion acquisition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02810795, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.