Cardiac DiseaseNCT02550366
Accelerated Contrast-Enhanced High Resolution Whole Heart Cardiac MRI
An observational study of Cardiac Disease, run by University of Minnesota at 1 site in United States.
Trial summary
Coronary artery disease (CAD) is the leading cause of death in the United States. Cardiac MRI is a non-invasive non-ionizing technique for a comprehensive cardiac exam, which can be used in the diagnosis of CAD. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- MRI Contrast
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 19 Jan 2024
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult population with no contraindication to magnetic resonance imaging
Who may be able to join
- "Healthy" subjects 18 years and older
- Cardiovascular disease patients referred from the Department of Cardiology, who do not meet any of the exclusion criteria.
Who cannot join
- Exclusion criteria include those associated with the use of MR as the imaging modality. Patients with pacemakers, implanted cardioverter-defibrillators, intracerebral clips or other implants that are not MR incompatible, atrial flutter or frequent atrial or ventricular ectopic activity, weight over 250 pounds, or significant claustrophobia will be excluded.
- Subjects should not have the following which may be hazardous to their health or interfere with MRI examinations: cardiac pacemaker; implanted cardiac defibrillator; carotid artery vascular clamp; intravascular stents, filters, or coils; aortic clip; internal pacing wires; vascular access port and/or catheter; Swan-Ganz catheter; shunt (spinal or intraventricular); aneurysm clip(s); neurostimulator; electrodes (on body, head, or brain);heart valve prosthesis; any type of prosthesis (eye, penile, etc.); artificial limb or joint replacement; bone growth/fusion stimulator; bone/joint pin, screw, nail, wire, plate; metal rods in bones; Harrington rods (spine); metal or wire mesh implants; wire sutures or surgical staples; insulin pump or infusion device; any metal fragments (i.e. metal shop); any implant held in place by a magnet; cochlear, otologic, or ear implant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Accelerated Contrast-Enhanced High Resolution Whole Heart Cardiac MR for Non-Invasive Evaluation of Coronary Artery Disease
Coronary artery disease (CAD) is the leading cause of death in the United States. Cardiac MRI is a non-invasive non-ionizing technique for a comprehensive cardiac exam, which can be used in the diagnosis of CAD. In this work, the investigators will develop and validate techniques for accelerated cardiac MRI, offering better volumetric coverage of the heart, improved contrast, and superior spatial and temporal resolutions.
Read the detailed description
Coronary artery disease (CAD) is the leading cause of death in the United States, even though significant efforts have been made in prevention and diagnosis. The clinical gold standard for diagnosis of CAD is catheter-based invasive x-ray angiography, performed more than a million times per year. Of these examinations, up to 35% have been found to have no significant stenosis, yet these patients had to go through the potential risks and complications of an invasive test that further exposes the patient to ionizing radiation and iodinated contrast. Thus, non-invasive diagnostic alternatives are highly desirable.
Cardiac MRI (CMR) provides a method for a comprehensive non-invasive cardiac exam, including contractile functional assessment (cine) to detect wall-motion abnormality, myocardial CMR perfusion for diagnosing perfusion defects, viability assessment using late gadolinium enhancement for evaluation of acute and chronic myocardial infarction, and coronary MRI for the identification of stenosis. CMR is advantageous in several respects, since it does not require ionizing radiation or iodinated contrast, thereby facilitating repeated or follow-up scanning. However, long data acquisition time remains as one of its main limitations. Several approaches have been studied to facilitate rapid CMR acquisition. Nonetheless, the acquisition time for high-resolution CMR remains long, and spatial and temporal resolution is traded off for acquisition time. Therefore, developments of methods to reduce the duration of data acquisition beyond what is available now are appealing. The investigators will develop novel reconstruction methodologies for high-resolution CMR that learn the anatomical structures in the images being reconstructed. The investigators will validate these techniques in a range of contrast-enhanced CMR imaging protocols, providing better volumetric coverage of the heart, efficient use of the contrast agents, and higher spatial and temporal resolution.
- Conditions
- Cardiac Disease
- Being tested
- MRI Contrast
- Keywords
- Cardiac MRI, Accelerate imaging, coronary artery disease
- Medical subject headings
- Heart Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI ContrastDrug
MRI Contrast
| Study group | Role | What they receive |
|---|---|---|
| CMR | Subjects with no contraindication to magnetic resonance imaging, who will undergo cardiac MRI scanning. Receives: Drug: MRI Contrast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative comparison of the proposed techniques with existing imaging techniques
vessel length and sharpness
Measured: 1 and 3 years
infarct size,
quantitative measures
Measured: 1 and 3 years
left and right ventricular volumes and masses,
quantitative measures
Measured: 1 and 3 years
time-intensity-curve upslopes,
quantitative measures
Measured: 1 and 3 years
high-resolution approaches with existing standard resolution imaging technique
quantitative measures
Measured: 1 and 3 years
Secondary outcomes (3)
presence of stenosis (yes/no dichotomous)
Qualitative comparison
Measured: 1 and 3 years
presence of infarct (yes/no dichotomous),
Qualitative comparison
Measured: 1 and 3 years
image quality (scores range from 1 [poor] to 4 [excellent]).
Qualitative comparison
Measured: 1 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study start1 Jan 2016
- Primary completion19 Jan 2024
- Study completion19 Jan 2024
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 Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehmet Akcakaya, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550366
- Sponsor's protocol ID
- CMR_CE_WH_AccMRI
- Status last verified
- Jan 2024
- First submitted
- 27 Aug 2015
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akcakaya M, Basha TA, Chan RH, Manning WJ, Nezafat R. Accelerated isotropic sub-millimeter whole-heart coronary MRI: compressed sensing versus parallel imaging. Magn Reson Med. 2014 Feb;71(2):815-22. doi: 10.1002/mrm.24683.
PubMed 23440946Akcakaya M, Basha TA, Pflugi S, Foppa M, Kissinger KV, Hauser TH, Nezafat R. Localized spatio-temporal constraints for accelerated CMR perfusion. Magn Reson Med. 2014 Sep;72(3):629-39. doi: 10.1002/mrm.24963. Epub 2013 Oct 7.
PubMed 24123058
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Accelerated Contrast-Enhanced High Resolution Whole Heart Cardiac MR for Non-Invasive Evaluation of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02550366
- Acronym / sponsor ID
- CMR_CE_WH_AccMRI
- Conditions
- Cardiac Disease
- Keywords
- Cardiac MRI, Accelerate imaging, coronary artery disease
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 15 Sep 2015 (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.
Coronary artery disease (CAD) is the leading cause of death in the United States. Cardiac MRI is a non-invasive non-ionizing technique for a comprehensive cardiac exam, which can be used in the diagnosis of CAD. In this work, the investigators will develop and validate techniques for accelerated cardiac MRI, offering better volumetric coverage of the heart, improved contrast, and superior spatial and temporal resolutions.
Detailed description
Coronary artery disease (CAD) is the leading cause of death in the United States, even though significant efforts have been made in prevention and diagnosis. The clinical gold standard for diagnosis of CAD is catheter-based invasive x-ray angiography, performed more than a million times per year. Of these examinations, up to 35% have been found to have no significant stenosis, yet these patients had to go through the potential risks and complications of an invasive test that further exposes the patient to ionizing radiation and iodinated contrast. Thus, non-invasive diagnostic alternatives are highly desirable.
Cardiac MRI (CMR) provides a method for a comprehensive non-invasive cardiac exam, including contractile functional assessment (cine) to detect wall-motion abnormality, myocardial CMR perfusion for diagnosing perfusion defects, viability assessment using late gadolinium enhancement for evaluation of acute and chronic myocardial infarction, and coronary MRI for the identification of stenosis. CMR is advantageous in several respects, since it does not require ionizing radiation or iodinated contrast, thereby facilitating repeated or follow-up scanning. However, long data acquisition time remains as one of its main limitations. Several approaches have been studied to facilitate rapid CMR acquisition. Nonetheless, the acquisition time for high-resolution CMR remains long, and spatial and temporal resolution is traded off for acquisition time. Therefore, developments of methods to reduce the duration of data acquisition beyond what is available now are appealing. The investigators will develop novel reconstruction methodologies for high-resolution CMR that learn the anatomical structures in the images being reconstructed. The investigators will validate these techniques in a range of contrast-enhanced CMR imaging protocols, providing better volumetric coverage of the heart, efficient use of the contrast agents, and higher spatial and temporal resolution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMR | – | Drug: MRI ContrastSubjects with no contraindication to magnetic resonance imaging, who will undergo cardiac MRI scanning. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult population with no contraindication to magnetic resonance imaging
Key inclusion criteria (2 listed)
- "Healthy" subjects 18 years and older
- Cardiovascular disease patients referred from the Department of Cardiology, who do not meet any of the exclusion criteria.
Key exclusion criteria (2 listed)
- Exclusion criteria include those associated with the use of MR as the imaging modality. Patients with pacemakers, implanted cardioverter-defibrillators, intracerebral clips or other implants that are not MR incompatible, atrial flutter or frequent atrial or ventricular ectopic activity, weight over 250 pounds, or significant claustrophobia will be excluded.
- Subjects should not have the following which may be hazardous to their health or interfere with MRI examinations: cardiac pacemaker; implanted cardiac defibrillator; carotid artery vascular clamp; intravascular stents, filters, or coils; aortic clip; internal pacing wires; vascular access port and/or catheter; Swan-Ganz catheter; shunt (spinal or intraventricular); aneurysm clip(s); neurostimulator; electrodes (on body, head, or brain);heart valve prosthesis; any type of prosthesis (eye, penile, etc.); artificial limb or joint replacement; bone growth/fusion stimulator; bone/joint pin, screw, nail, wire, plate; metal rods in bones; Harrington rods (spine); metal or wire mesh implants; wire sutures or surgical staples; insulin pump or infusion device; any metal fragments (i.e. metal shop); any implant held in place by a magnet; cochlear, otologic, or ear implant.
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 |
|---|---|---|
| MRI ContrastMRI Contrast | Drug | CMR |
Primary outcome
Quantitative comparison of the proposed techniques with existing imaging techniques
Time frame: 1 and 3 years
vessel length and sharpness
infarct size,
Time frame: 1 and 3 years
quantitative measures
left and right ventricular volumes and masses,
Time frame: 1 and 3 years
quantitative measures
time-intensity-curve upslopes,
Time frame: 1 and 3 years
quantitative measures
high-resolution approaches with existing standard resolution imaging technique
Time frame: 1 and 3 years
quantitative measures
3 secondary outcomes
presence of stenosis (yes/no dichotomous)
Time frame: 1 and 3 years
presence of infarct (yes/no dichotomous),
Time frame: 1 and 3 years
image quality (scores range from 1 [poor] to 4 [excellent]).
Time frame: 1 and 3 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Results publication: PubMed 23440946Akcakaya M, Basha TA, Chan RH, Manning WJ, Nezafat R. Accelerated isotropic sub-millimeter whole-heart coronary MRI: compressed sensing versus parallel imaging. Magn Reson Med. 2014 Feb;71(2):815-22. doi: 10.1002/mrm.24683.
- Results publication: PubMed 24123058Akcakaya M, Basha TA, Pflugi S, Foppa M, Kissinger KV, Hauser TH, Nezafat R. Localized spatio-temporal constraints for accelerated CMR perfusion. Magn Reson Med. 2014 Sep;72(3):629-39. doi: 10.1002/mrm.24963. Epub 2013 Oct 7.
- 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.
Mehmet Akcakaya, PhD principal investigator
University of Minnesota
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 Cardiac Disease, run by University of Minnesota 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 2 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: stopped early, as of the sponsor's last update on 23 Jan 2024. 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 was stopped early. Results are not available in the source record.
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?
Quantitative comparison of the proposed techniques with existing imaging techniques (time frame: 1 and 3 years). The study lists 5 primary outcomes in all. 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 NCT02550366, 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 23 Jan 2024.