Coronary Artery DiseaseNCT05609214
Complementary Investigation of Perfusion and Anatomy Measures of the Heart With MRI and Combined PET/MRI
An observational study of Coronary Artery Disease, run by University of Zurich at 1 site in Switzerland.
Trial summary
The goal of this observational study is to evaluate the complimentary information of anatomy, perfusion and viability of PET and MR. The main question[s] it aims to answer are: to compare perfusion and anatomy measurements and perfusion related signals from PET and MR imaging and estimate its prognostic values. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Nov 2022to 13 Aug 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with known or suspected coronary artery disease who are referred for noninvasive cardiac evaluation, clinically indicated cardiac anatomy, viability and/or perfusion evaluation by MRI or PET scan
Who may be able to join
- Male and Female participants over the age of 18 years
- Written informed consent by the participant after information about the research project
- Symptoms consistent with possible coronary artery disease
- Clinical referral for a vasodilator stress CMR and/or PET examination
Who cannot join
- Patients with high degree heart block
- Contraindications to gadolinium-enhanced CMR examination
- Severe claustrophobia
- Specific implantable devices which are contraindicated for CMR
- Current pregnancy
- Advanced renal disease (GFR<30)
- Uncontrolled obstructive pulmonary disease or asthma
- Atrial fibrillation at the time of study enrolment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMPLEMENTARY INVESTIGATION OF PERFUSION AND ANATOMY MEASURES OF THE HEART WITH MRI AND COMBINED PET/MRI
The goal of this observational study is to evaluate the complimentary information of anatomy, perfusion and viability of PET and MR. The main question[s] it aims to answer are:
- to compare perfusion and anatomy measurements and perfusion related signals from PET and MR imaging and estimate its prognostic values.
- to evaluate potential optimization of routine scanning procedure with regards to completeness and potential added value of quantitative measurements.
Read the detailed description
Stress perfusion cardiac magnetic resonance (CMR), Cardiac Computed Tomography (CT) and Positron Emission Tomography (PET) are well-established non-invasive imaging tests that are increasingly being used for the assessment of patients with known or suspected ischemic heart disease [1]. While all of these clinically established modalities have different characteristics and thus inherent advantages and disadvantages, none of them alone allows simultaneous exclusive visualization of anatomic, functional, and metabolic features of the heart. Stress CMR provides an accu-rate assessment of cardiac function [2, 3], myocardial scar [4, 5], and myocardial ischemia [6-8]. However, stress perfusion CMR remains underutilized for the assessment of chest pain compared with other non-invasive methods [8]. This is in part due to cost, inadequate access to the technology, long scan times, and an insufficient number of physicians with expertise to interpret the images while automated analysis is not well established for CMR. On the other side, stress PET perfusion imaging can accurately assess myocardial scar and myocardial ischemia and has moreover the unique ability to quantify myocardial blood flow [9, 10].
Given this discrepancy between the professional guidelines supporting the use of stress CMR and the lack of adoption into clinical practice, there is significant interest in developing: (A) more efficient and higher quality image acquisition and (B) more automated and quantitative image analysis approaches to improve the utilization of and access to stress CMR. One such improvement is the modification of the magnetic resonance imaging (MRI) pulse sequence currently used to assess myocardial perfusion so that it can also simultaneously be used to provide the information necessary to quantify myocardial blood flow [11]. Indeed when combined with a specially designed image analysis software, this modified pulse sequence provides images that can be used to automatically quantify myocardial blood flow on a pixel-by-pixel basis [12].
Further improvements in the software used to acquire and analyse stress CMR images are needed to make this important diagnostic tool more accessible to patients that would benefit from it.
Hence, the primary goal of this study is to compare in a larger patient sample perfusion and metabolism assessed by MR or complimentary by PET and MR in terms of identifying individuals with myocardial perfusion defects. Furthermore, in those patients where cardiac CT and invasive coro-nary angiography data is available (from clinical routine examinations), complimentary anatomy and perfusion measures of CT, PET, coronary angiography, and MR measurements will be assessed as well. Within this study a comparison of various assessments and possible readouts will be compared with regards values and parameters received. Typical readouts used in clinical routine and available automated algorithms will be used. The goal is to evaluate current clinical protocols, its benefits and potential optimization.
Additionally, this study will submit data into a multicentric data registry in order to efficiently test and validate potential of future technological developments in CMR. Therefore, the de-identified images and raw data acquired will be collected from multiple centers and stored at a HIPAA-compliant repository at University of Chicago Medicine and the University of Virginia. The images which would fulfill the criteria for this register will be further processed. The de-identified imaging and clinical data will be distributed to a Core Laboratory located at McGill University (Montreal, Canada) and also to other academic partners for image processing, image analysis, and software development. Additionally, downstream testing and patient outcomes will be collected as pilot data towards determining the clinical impact of automated quantitative myocardial blood flow analysis of stress CMR images.
- Conditions
- Coronary Artery Disease
- Keywords
- Myocardial Perfusion
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Complimentary information on perfusion and metabolism
To evaluate complimentary information on perfusion and metabolism assessed by PET and MR imaging to better identify individuals with known or suspected coronary artery disease
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start21 Nov 2022
- Primary completion13 Aug 2026
- Study completion13 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aju P Pazhenkottil, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609214
- Sponsor's protocol ID
- 2021-02520
- Status last verified
- Aug 2025
- First submitted
- 1 Nov 2022
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPLEMENTARY INVESTIGATION OF PERFUSION AND ANATOMY MEASURES OF THE HEART WITH MRI AND COMBINED PET/MRI
- ClinicalTrials.gov ID
- NCT05609214
- Acronym / sponsor ID
- 2021-02520
- Conditions
- Coronary Artery Disease
- Keywords
- Myocardial Perfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 13 Aug 2026 (actual)
- Study completion
- 13 Aug 2026 (actual)
- First posted
- 8 Nov 2022 (actual)
- 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 goal of this observational study is to evaluate the complimentary information of anatomy, perfusion and viability of PET and MR. The main question[s] it aims to answer are:
- to compare perfusion and anatomy measurements and perfusion related signals from PET and MR imaging and estimate its prognostic values.
- to evaluate potential optimization of routine scanning procedure with regards to completeness and potential added value of quantitative measurements.
Detailed description
Stress perfusion cardiac magnetic resonance (CMR), Cardiac Computed Tomography (CT) and Positron Emission Tomography (PET) are well-established non-invasive imaging tests that are increasingly being used for the assessment of patients with known or suspected ischemic heart disease [1]. While all of these clinically established modalities have different characteristics and thus inherent advantages and disadvantages, none of them alone allows simultaneous exclusive visualization of anatomic, functional, and metabolic features of the heart. Stress CMR provides an accu-rate assessment of cardiac function [2, 3], myocardial scar [4, 5], and myocardial ischemia [6-8]. However, stress perfusion CMR remains underutilized for the assessment of chest pain compared with other non-invasive methods [8]. This is in part due to cost, inadequate access to the technology, long scan times, and an insufficient number of physicians with expertise to interpret the images while automated analysis is not well established for CMR. On the other side, stress PET perfusion imaging can accurately assess myocardial scar and myocardial ischemia and has moreover the unique ability to quantify myocardial blood flow [9, 10].
Given this discrepancy between the professional guidelines supporting the use of stress CMR and the lack of adoption into clinical practice, there is significant interest in developing: (A) more efficient and higher quality image acquisition and (B) more automated and quantitative image analysis approaches to improve the utilization of and access to stress CMR. One such improvement is the modification of the magnetic resonance imaging (MRI) pulse sequence currently used to assess myocardial perfusion so that it can also simultaneously be used to provide the information necessary to quantify myocardial blood flow [11]. Indeed when combined with a specially designed image analysis software, this modified pulse sequence provides images that can be used to automatically quantify myocardial blood flow on a pixel-by-pixel basis [12].
Further improvements in the software used to acquire and analyse stress CMR images are needed to make this important diagnostic tool more accessible to patients that would benefit from it.
Hence, the primary goal of this study is to compare in a larger patient sample perfusion and metabolism assessed by MR or complimentary by PET and MR in terms of identifying individuals with myocardial perfusion defects. Furthermore, in those patients where cardiac CT and invasive coro-nary angiography data is available (from clinical routine examinations), complimentary anatomy and perfusion measures of CT, PET, coronary angiography, and MR measurements will be assessed as well. Within this study a comparison of various assessments and possible readouts will be compared with regards values and parameters received. Typical readouts used in clinical routine and available automated algorithms will be used. The goal is to evaluate current clinical protocols, its benefits and potential optimization.
Additionally, this study will submit data into a multicentric data registry in order to efficiently test and validate potential of future technological developments in CMR. Therefore, the de-identified images and raw data acquired will be collected from multiple centers and stored at a HIPAA-compliant repository at University of Chicago Medicine and the University of Virginia. The images which would fulfill the criteria for this register will be further processed. The de-identified imaging and clinical data will be distributed to a Core Laboratory located at McGill University (Montreal, Canada) and also to other academic partners for image processing, image analysis, and software development. Additionally, downstream testing and patient outcomes will be collected as pilot data towards determining the clinical impact of automated quantitative myocardial blood flow analysis of stress CMR images.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with known or suspected coronary artery disease who are referred for noninvasive cardiac evaluation, clinically indicated cardiac anatomy, viability and/or perfusion evaluation by MRI or PET scan
Key inclusion criteria (4 listed)
- Male and Female participants over the age of 18 years
- Written informed consent by the participant after information about the research project
- Symptoms consistent with possible coronary artery disease
- Clinical referral for a vasodilator stress CMR and/or PET examination
Key exclusion criteria (8 listed)
- Patients with high degree heart block
- Contraindications to gadolinium-enhanced CMR examination
- Severe claustrophobia
- Specific implantable devices which are contraindicated for CMR
- Current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complimentary information on perfusion and metabolism
Time frame: 2 years
To evaluate complimentary information on perfusion and metabolism assessed by PET and MR imaging to better identify individuals with known or suspected coronary artery disease
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 21 Aug 2026.
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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.
Aju P Pazhenkottil principal investigator
University of Zurich
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 University of Zurich at 1 site in Switzerland.
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 8 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 21 Aug 2026. 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 Switzerland. 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?
Complimentary information on perfusion and metabolism (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2026.