Heart Disease, IschemicPhase 2/3NCT01234870
Comprehensive Evaluation of Ischemic Heart Disease Using MRI
A Phase 2/3 study testing Gadolinium and Adenosine in people with Heart Disease, Ischemic and Atherosclerosis, Coronary, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of the study is to assess the diagnostic performance of fully automated motion corrected (MC) first pass myocardial perfusion MRI, compared to the original non-corrected first pass myocardial perfusion images in a cohort of patients with suspected ischemic heart disease, using coronary angiography as the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease, Ischemic, Atherosclerosis, Coronary
- What is being tested?
- Gadolinium and Adenosine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jan 2012
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Under an Institutional Committee on Human Research board approved protocol 80 patients with a suspected myocardial ischemic disease recruited from the cardiac cath laboratory will be recruited in this prospective study. Volunteers will be recruited for the purpose of protocol development and will not be included in analysis. All subjects will be screened for glomerular filtration rate (GFR) within 24 hours before the exam. All patients must have a GFR > 30 mL/min/1.73m2 to be part of the study.
- All subjects will be selected following the Nephrogenic Systemic Fibrosis (NSF) guidelines. All dialysis patients or end-stage renal disease patients with a creatinine clearance of < 30 mL/min will not be selected for the study to avoid NSF. Patients with GFR < 60 ml/min but >30 ml/min will receive a reduced dose of Gadolinium contrast (0.1 ml/kg).
Who cannot join
- Age <18 years;
- Known contraindication to MR imaging (such as pacemaker placement, magnetic implants, etc);
- Claustrophobia;
- Inability to perform an adequate breath-hold for imaging,
- Inability to provide informed consent;
- all subjects will be will be screened for GFR within 24 hours before the exam and subjects presenting with GFR < 30 ml/min will be excluded;
Show all 27Show fewer
- Pregnant and lactating women;
- Patients with hypersensitivity to gadolinium contrast agents, metoprolol, adenosine, or nitroglycerin;
- Contra indication for Adenosine
- 2nd- or 3rd-degree atrioventricular block (except in patients with a functioning artificial pacemaker)
- Sinus node disease (except in patients with a functioning artificial
- pacemaker)
- Unstable angina
- Acute myocardial infarction
- Known or suspected bronchoconstrictive or bronchospastic lung
- disease (e.g., asthma)
- Hypersensitivity to adenosine
- Caffeine within 12-24 hours
- Theophylline and Dipyridamole products within 24 hours.
- Contra indication for Metoprolol
- sinus bradycardia
- heart block greater than first degree
- Cardiac Failure
- Bronchospastic Disease
- Contra indication for Nitroglycerin
- Early myocardial infarction, severe anemia, increased intracranial pressure, and those with a known hypersensitivity to nitroglycerin.
- b .Administration of Nitrostat (nitroglycerin tablets, USP) is contraindicated in patients who are using Viagra® since Viagra has been shown to potentiate the hypotensive effects of organic nitrates.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to assess the diagnostic performance of fully automated motion corrected (MC) first pass myocardial perfusion MRI, compared to the original non-corrected first pass myocardial perfusion images in a cohort of patients with suspected ischemic heart disease, using coronary angiography as the reference standard. It is expected that this improved comprehensive protocol for cardiac MRI be accurate at detecting significant coronary artery disease and may obviate the need for other more expensive and invasive diagnostic tests currently used.
Read the detailed description
Coronary heart disease is the leading cause of death and disability in the US, accounting for about one-third of all deaths in subjects over age 35.
With the development of newer Magnetic Resonance Imaging (MRI) techniques, such as faster pulse sequences and parallel imaging, cardiac MRI has become a routine tool for the evaluation and detection of myocardial ischemic disease. First pass myocardial perfusion (FPMP) using MRI is increasingly being used to assess ischemic heart disease. MRI offers the advantages of spatial resolution sufficient to differentiate between subendocardial and subepicardial perfusion; shorter examination time and also lack of ionizing radiation. Left ventricle cine gradient echo imaging can be used to assess regional ventricular function. Left ventricular myocardial viability can also be easily assessed at the same time in order to determine the amount of viable left ventricular myocardium and the percentage of irreversibly scarred myocardium by delayed enhanced images. Viability imaging is usually added to the perfusion protocol to increase specificity by allowing detection of fixed perfusion defects, which represent scar. The ultimate cardiac MRI protocol would be to combine both of these imaging strategies with a reliable and accurate coronary Magnetic Resonance Angiography(MRA) technique, such that obstructive coronary artery disease could be evaluated comprehensively at the same time. If all of these techniques can be combined together in a single study, it may be feasible to finally achieve a "one stop shop" for cardiac Magnetic Resonance Imaging.
- Conditions
- Heart Disease, Ischemic, Atherosclerosis, Coronary
- Being tested
- Gadolinium, Adenosine
- Keywords
- Myocardial Perfusion Imaging, Magnetic Resonance Imaging
- Medical subject headings
- Myocardial Ischemia, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GadoliniumDrug
Also called Magnevist, Bayer HealthCare Pharmaceuticals
AdenosineDrug
| Study group | Role | What they receive |
|---|---|---|
| Ischemic heart disease patients | Experimental | Patients with suspected ischemic heart disease prospectively recruited for first pass myocardial perfusion MRI. All subject to receive Gadolinium infusion of 0.075 mmol/kg at rate of 4 ml/sec. Adenosine administered at a rate of 0.14 mg/kg/min for a duration of 4 minutes to induce stress. Receives: Drug: Gadolinium; Drug: Adenosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic Resonance Image Quality Rating
The purpose of the study is to assess the incremental value of diagnostic performance using a fully-automated, motion-corrected (MC) first pass myocardial perfusion image acquisition protocol compared to images obtained under a non-corrected, breath-hold, shallow-breathing first pass myocardial perfusion image acquisition protocol in patients with suspected ischemic heart disease. The MR images resulting from two different image acquisition techniques, including Non-Corrected Breath-Hold Shallow-Breathing and Motion-Corrected, were assessed independently by two radiologists (average of 7 years of experience in reading cardiac MRI) using the American Heart Association modified 16 segment model and were evaluated using a four point Likert scale (1 = poor, 2 = fair, 3 = good, and 4 = excellent) for image quality
Measured: Cross sectional study; magnetic resonance images were obtained on all patients using two different acquisition methods.
Secondary outcomes (1)
Number of Participants With Adverse Events to Demonstrate Feasibility of a Comprehensive Cardiac Magnetic Resonance Imaging Protocol
Adverse events relating to administration of adenosine during a coronary heart disease comprehensive cardiac MRI study.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart Disease, IschemicStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma US, Inc., Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Responsible party
- Principal investigator, James Carr, Northwestern University
- Investigators
- James C Carr, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234870
- Sponsor's protocol ID
- CR1_STU00006013
- Other IDs
- ASCA-9J02
- Status last verified
- Sep 2014
- First submitted
- 5 Oct 2010
- Last updated
- 26 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Evaluation of Ischemic Heart Disease Using MRI
- ClinicalTrials.gov ID
- NCT01234870
- Acronym / sponsor ID
- CR1_STU00006013
- Conditions
- Heart Disease, Ischemic, Atherosclerosis, Coronary
- Keywords
- Myocardial Perfusion Imaging, Magnetic Resonance Imaging
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Astellas Pharma US, Inc., Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Study start
- Jun 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 4 Nov 2010 (estimated)
- Results
- Posted 26 Sep 2014
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 the study is to assess the diagnostic performance of fully automated motion corrected (MC) first pass myocardial perfusion MRI, compared to the original non-corrected first pass myocardial perfusion images in a cohort of patients with suspected ischemic heart disease, using coronary angiography as the reference standard. It is expected that this improved comprehensive protocol for cardiac MRI be accurate at detecting significant coronary artery disease and may obviate the need for other more expensive and invasive diagnostic tests currently used.
Detailed description
Coronary heart disease is the leading cause of death and disability in the US, accounting for about one-third of all deaths in subjects over age 35.
With the development of newer Magnetic Resonance Imaging (MRI) techniques, such as faster pulse sequences and parallel imaging, cardiac MRI has become a routine tool for the evaluation and detection of myocardial ischemic disease. First pass myocardial perfusion (FPMP) using MRI is increasingly being used to assess ischemic heart disease. MRI offers the advantages of spatial resolution sufficient to differentiate between subendocardial and subepicardial perfusion; shorter examination time and also lack of ionizing radiation. Left ventricle cine gradient echo imaging can be used to assess regional ventricular function. Left ventricular myocardial viability can also be easily assessed at the same time in order to determine the amount of viable left ventricular myocardium and the percentage of irreversibly scarred myocardium by delayed enhanced images. Viability imaging is usually added to the perfusion protocol to increase specificity by allowing detection of fixed perfusion defects, which represent scar. The ultimate cardiac MRI protocol would be to combine both of these imaging strategies with a reliable and accurate coronary Magnetic Resonance Angiography(MRA) technique, such that obstructive coronary artery disease could be evaluated comprehensively at the same time. If all of these techniques can be combined together in a single study, it may be feasible to finally achieve a "one stop shop" for cardiac Magnetic Resonance Imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ischemic heart disease patients | Experimental | Drug: Gadolinium, Drug: AdenosinePatients with suspected ischemic heart disease prospectively recruited for first pass myocardial perfusion MRI. All subject to receive Gadolinium infusion of 0.075 mmol/kg at rate of 4 ml/sec. Adenosine administered at a rate of 0.14 mg/kg/min for a duration of 4 minutes to induce stress. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Under an Institutional Committee on Human Research board approved protocol 80 patients with a suspected myocardial ischemic disease recruited from the cardiac cath laboratory will be recruited in this prospective study. Volunteers will be recruited for the purpose of protocol development and will not be included in analysis. All subjects will be screened for glomerular filtration rate (GFR) within 24 hours before the exam. All patients must have a GFR > 30 mL/min/1.73m2 to be part of the study.
- All subjects will be selected following the Nephrogenic Systemic Fibrosis (NSF) guidelines. All dialysis patients or end-stage renal disease patients with a creatinine clearance of < 30 mL/min will not be selected for the study to avoid NSF. Patients with GFR < 60 ml/min but >30 ml/min will receive a reduced dose of Gadolinium contrast (0.1 ml/kg).
Key exclusion criteria (27 listed)
- Age <18 years;
- Known contraindication to MR imaging (such as pacemaker placement, magnetic implants, etc);
- Claustrophobia;
- Inability to perform an adequate breath-hold for imaging,
- Inability to provide informed consent;
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 |
|---|---|---|
| GadoliniumAlso: Magnevist, Bayer HealthCare Pharmaceuticals | Drug | Ischemic heart disease patients |
| Adenosine | Drug | Ischemic heart disease patients |
Primary outcome
Magnetic Resonance Image Quality Rating
Time frame: Cross sectional study; magnetic resonance images were obtained on all patients using two different acquisition methods.
The purpose of the study is to assess the incremental value of diagnostic performance using a fully-automated, motion-corrected (MC) first pass myocardial perfusion image acquisition protocol compared to images obtained under a non-corrected, breath-hold, shallow-breathing first pass myocardial perfusion image acquisition protocol in patients with suspected ischemic heart disease. The MR images resulting from two different image acquisition techniques, including Non-Corrected Breath-Hold Shallow-Breathing and Motion-Corrected, were assessed independently by two radiologists (average of 7 years of experience in reading cardiac MRI) using the American Heart Association modified 16 segment model and were evaluated using a four point Likert scale (1 = poor, 2 = fair, 3 = good, and 4 = excellent) for image quality
1 secondary outcome
Number of Participants With Adverse Events to Demonstrate Feasibility of a Comprehensive Cardiac Magnetic Resonance Imaging Protocol
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
James C Carr, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Gadolinium and Adenosine in people with Heart Disease, Ischemic and Atherosclerosis, Coronary, run by Northwestern University 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 2 inclusion and 27 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 26 Sep 2014. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Magnetic Resonance Image Quality Rating (time frame: Cross sectional study; magnetic resonance images were obtained on all patients using two different acquisition methods.). 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 26 Sep 2014; AzTrials last refreshed its copy on 1 Nov 2026.