Coronary Artery DiseaseNCT02697877
Assessment of Global Myocardial Perfusion Reserve Using Coronary Sinus Flow Measurements
An observational study of Coronary Artery Disease, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The aim of this study is to assess whether myocardial perfusion reserve, measured during routine clinically ordered regadenoson stress cardiac magnetic resonance (CMR) has prognostic value in predicting adverse cardiovascular events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Regadenoson
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Jul 2018
- 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 ≥ 18yrs who are undergoing clinically indicated stress cardiac magnetic resonance (CMR) imaging for known or suspected coronary artery disease.
Who may be able to join
- Age ≥18
- Male or Female
- Referred for clinical cardiac magnetic resonance stress testing (with Regadenoson) at the University of Illinois Hospital \& Health Sciences System by their healthcare provider as part of their routine clinical care for known or suspected coronary artery disease.
Who cannot join
- Presence of metallic implants contraindicated with cardiac magnetic resonance (e.g. implantable cardiac defibrillator, pacemaker)
- Glomerular Filtration Rate (GFR) <30ml/min
- High degree atrio-ventricular block
- Hypersensitivity to Regadenoson
- Severe active wheezing from asthma
- Severe claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
1740 W Taylor Street, 2nd Floor, Cardiac Imaging
Chicago, Illinois, 60612
About this study
Official title: Assessment and Prognostic Significance of Global Myocardial Perfusion Reserve Using Coronary Sinus Flow Measurements During Regadenoson Stress Cardiac Magnetic Resonance
The aim of this study is to assess whether myocardial perfusion reserve, measured during routine clinically ordered regadenoson stress cardiac magnetic resonance (CMR) has prognostic value in predicting adverse cardiovascular events. Myocardial perfusion reserve will be measured with CMR by assessing blood flow through the coronary-sinus - the primary vein in the heart.
Read the detailed description
Myocardial perfusion reserve is the ratio of global myocardial blood flow at stress vs. rest. Traditionally, it has been measured non-invasively using quantitative positron emission tomography (PET) or cardiac magnetic resonance (CMR). Several recent studies have suggested that measurement of myocardial perfusion reserve provides significant additive prognostic information during stress perfusion imaging in patients with known or suspected coronary artery disease. Myocardial perfusion reserve depends not only on trans-stenotic pressure gradient of the epicardial arteries and thus stenosis severity but even more on the ability of the coronary microvasculature (especially the pre-arterioles) to dilate. Therefore, coronary microvascular dysfunction, which impairs pre-arteriolar function, reduces myocardial perfusion reserve independently of the presence of epicardial coronary stenosis. Hence, the ability to measure myocardial perfusion reserve allows a more comprehensive assessment of the entire coronary circulation, beyond the current paradigm of the epicardial arteries.
However, both PET and current CMR techniques are cumbersome, and in the case of PET require radiation as well as on-site Rubidium-82 generators. Therefore, they are challenging for routine clinical practice and have been limited to specialized research centers. An alternative, simple CMR method for measurement of myocardial perfusion reserve by quantifying change in coronary sinus flow has been described. The coronary sinus drains approximately 96% of total myocardial blood flow and provides a potentially convenient location for measurement of global myocardial blood flow. This method has been validated against both invasive and PET techniques. The investigators hypothesized that measurement of coronary sinus flow at stress and rest may provide a simple and rapid assessment of myocardial perfusion reserve during regadenoson stress perfusion CMR.
This study will use phase contrast images obtained from patients during their clinically indicated CMR stress study to calculate myocardial perfusion reserve as the ratio of maximum myocardial blood flow to baseline blood flow - at the coronary sinus. Coronary sinus flow will be calculated by post-processing of images after the patient has left the scanner. In brief, the contour of the coronary sinus will be traced on the flow images throughout the cardiac cycle. Coronary sinus flow is calculated by integrating the momentary flow rate values from each cardiac phase over the entire cardiac cycle and multiplying by the mean heart rate during the acquisition. Patients will be followed for the occurrence of major adverse cardiac events (death, myocardial infarction, late revascularization, hospitalization for heart failure or unstable angina).
- Conditions
- Coronary Artery Disease
- Being tested
- Regadenoson
- 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.
RegadenosonDrug
| Study group | Role | What they receive |
|---|---|---|
| Patients with known or suspected coronary artery disease. | Patients with known or suspected coronary artery disease undergoing clinically ordered stress cardiac magnetic resonance imaging. Receives: Drug: Regadenoson |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
Measured: For upto 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2018
- Study completionJul 2018
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 Illinois ChicagoThe 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
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Principal investigator, Afshin Farzaneh-Far, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697877
- Sponsor's protocol ID
- 2015-1275
- Status last verified
- Oct 2019
- First submitted
- 24 Feb 2016
- Last updated
- 24 Oct 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Prognostic Significance of Global Myocardial Perfusion Reserve Using Coronary Sinus Flow Measurements During Regadenoson Stress Cardiac Magnetic Resonance
- ClinicalTrials.gov ID
- NCT02697877
- Acronym / sponsor ID
- 2015-1275
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- Feb 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 3 Mar 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 aim of this study is to assess whether myocardial perfusion reserve, measured during routine clinically ordered regadenoson stress cardiac magnetic resonance (CMR) has prognostic value in predicting adverse cardiovascular events. Myocardial perfusion reserve will be measured with CMR by assessing blood flow through the coronary-sinus - the primary vein in the heart.
Detailed description
Myocardial perfusion reserve is the ratio of global myocardial blood flow at stress vs. rest. Traditionally, it has been measured non-invasively using quantitative positron emission tomography (PET) or cardiac magnetic resonance (CMR). Several recent studies have suggested that measurement of myocardial perfusion reserve provides significant additive prognostic information during stress perfusion imaging in patients with known or suspected coronary artery disease. Myocardial perfusion reserve depends not only on trans-stenotic pressure gradient of the epicardial arteries and thus stenosis severity but even more on the ability of the coronary microvasculature (especially the pre-arterioles) to dilate. Therefore, coronary microvascular dysfunction, which impairs pre-arteriolar function, reduces myocardial perfusion reserve independently of the presence of epicardial coronary stenosis. Hence, the ability to measure myocardial perfusion reserve allows a more comprehensive assessment of the entire coronary circulation, beyond the current paradigm of the epicardial arteries.
However, both PET and current CMR techniques are cumbersome, and in the case of PET require radiation as well as on-site Rubidium-82 generators. Therefore, they are challenging for routine clinical practice and have been limited to specialized research centers. An alternative, simple CMR method for measurement of myocardial perfusion reserve by quantifying change in coronary sinus flow has been described. The coronary sinus drains approximately 96% of total myocardial blood flow and provides a potentially convenient location for measurement of global myocardial blood flow. This method has been validated against both invasive and PET techniques. The investigators hypothesized that measurement of coronary sinus flow at stress and rest may provide a simple and rapid assessment of myocardial perfusion reserve during regadenoson stress perfusion CMR.
This study will use phase contrast images obtained from patients during their clinically indicated CMR stress study to calculate myocardial perfusion reserve as the ratio of maximum myocardial blood flow to baseline blood flow - at the coronary sinus. Coronary sinus flow will be calculated by post-processing of images after the patient has left the scanner. In brief, the contour of the coronary sinus will be traced on the flow images throughout the cardiac cycle. Coronary sinus flow is calculated by integrating the momentary flow rate values from each cardiac phase over the entire cardiac cycle and multiplying by the mean heart rate during the acquisition. Patients will be followed for the occurrence of major adverse cardiac events (death, myocardial infarction, late revascularization, hospitalization for heart failure or unstable angina).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with known or suspected coronary artery disease. | – | Drug: RegadenosonPatients with known or suspected coronary artery disease undergoing clinically ordered stress cardiac magnetic resonance imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥ 18yrs who are undergoing clinically indicated stress cardiac magnetic resonance (CMR) imaging for known or suspected coronary artery disease.
Key inclusion criteria (3 listed)
- Age ≥18
- Male or Female
- Referred for clinical cardiac magnetic resonance stress testing (with Regadenoson) at the University of Illinois Hospital \& Health Sciences System by their healthcare provider as part of their routine clinical care for known or suspected coronary artery disease.
Key exclusion criteria (6 listed)
- Presence of metallic implants contraindicated with cardiac magnetic resonance (e.g. implantable cardiac defibrillator, pacemaker)
- Glomerular Filtration Rate (GFR) <30ml/min
- High degree atrio-ventricular block
- Hypersensitivity to Regadenoson
- Severe active wheezing from asthma
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 |
|---|---|---|
| Regadenoson | Drug | Patients with known or suspected coronary artery disease. |
Primary outcome
Major adverse cardiac events
Time frame: For upto 24 months
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 24 Oct 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Illinois Chicago at 1 site in United States.
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 3 inclusion and 6 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 24 Oct 2019. 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 United States. 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?
Major adverse cardiac events (time frame: For upto 24 months). 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 24 Oct 2019.