Cardiac DiseaseNCT03128268
The Effectiveness of 4D Image Acquisition and Post-processing With Vios Works
A study testing Imaging software for 4 dimensional images for Cardiac MRI in people with Cardiac Disease, run by Northwell Health at 1 site in United States.
Trial summary
This study aims to evaluate the effectiveness of 4D image acquisition and post-processing with Vios Works for the evaluation of 3D images acquired on GE Magnetic Resonance Imaging scanners. Specifically, the investigators propose to evaluate the following: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Imaging software for 4 dimensional images for Cardiac MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2018to 20 Jun 2023
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18 years of age or older
- with a valid prescription for Cardiac MRI for the following: Congenital heart disease/Shunts, Valvular heart disease, Pulmonary Hypertension, Aortic Disease, Hypertrophic Cardiomyopathy (HCM)
- receiving Standard of Care services at the MRI Center
- consent to participate in the 4D trial
Who cannot join
- Patients with any of the following will be excluded:
- Pacemaker or ICD implanted
- ICDs implanted
- Temporary Pacemakers (e.g. transvenous temporary wires)
- Leads that are abandoned (capped or retained leads not attached to device)
- Non-transvenous leads (e.g. epicardial leads)
Show all 9Show fewer
- Leads that have no fixation (e.g. floating leads)
- A lead that is known to be fractured
- Any other metallic objects that, in the opinion of the safety officer would compromise patient safety
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwell Health Imaging at Greenwich Village: a Division of Lenox Hill Hospital
New York, New York, 10011
About this study
Official title: THE EFFECTIVENESS OF 4D IMAGE ACQUISITION AND POST-PROCESSING WITH VIOS WORKS: A Phase Design Prospective Clinical Trial to Assess 4D Software Produced by GE and Arterys for Evaluating Cardiac Disease.
This study aims to evaluate the effectiveness of 4D image acquisition and post-processing with Vios Works for the evaluation of 3D images acquired on GE Magnetic Resonance Imaging scanners. Specifically, the investigators propose to evaluate the following:
- Image acquisition time using traditional 2D and new 4D processing techniques;
- Image quality for 2D and 4D processing techniques subjectively
- Post-processing time for the two techniques.
- Correlation of overall Left ventricular and right ventricular volumes and functions and aortic and pulmonic flow studies using the two techniques.
- The study will monitor any changes in patient diagnoses or treatment resulting from any differences in interpretations between the two processes.
Read the detailed description
Traditional scanning and post-processing of 2D Cardiac Magnetic Resonance images (CMRI) is highly technical and time consuming, with many exams requiring one to two hours to complete. In addition, performance of 2D scans often requires expert technologists working closely with the clinician imaging expert. These factors limit the general clinical utility of current generation cardiac MRI.
In order to address these factors, many researchers began to explore the use of 4D image acquisition and post processing to shorten exam time. These researchers have documented success at these efforts but, to the best of the current investigators' knowledge, such advanced imaging acquisition and post-processing systems are not readily commercially available in the US.
Recently GE teamed with Vios-Works for MRI to provide a cloud-based visualization platform for 4D MRI that provides quantitative and structured reporting in the post processing environment that makes use of advance MR imaging acquisition techniques. The images can be accessed by the interpreter and reviewed and manipulated in order to assess cardiac function and flow retrospectively, which, prior to this innovation, only has been available for computed tomography (CT) generated images.
This investigative team hypothesizes that the use of 4D imaging will result in reduced time for acquisition (approximately 6 minutes as opposed to 1 hour), and improvement of diagnostic capability.
Images will be acquired using the current standard 2D acquisition protocol for routine clinical cardiac MRI. A repeat acquisition will be completed using the new protocol for 4D imaging acquisition. This will require that patient exams be extended in length by six minutes for those enrolled in the study. The investigators will evaluate the image quality of the two techniques and grade them according to a scale of 1 to 3 with 1 being excellent cardiac borders easily identified; 2 - acceptable: cardiac borders acceptably identified; and 3, non-diagnostic. The investigators will specifically focus on the evaluation of cardiac function of both right and left ventricular function as well as flow analysis of both the aortic and pulmonic valves.
For each method, technician time and MD time will be collected. The exam will go through post processing for standard 2D, following by the new 4D post processing technique. Time for post processing will be collected. All subjects who agree will receive both a 2D and a 4D MRI. The investigators will evaluate inter and intra reader reliability by having all readers read the first 15 exams, and then read them a second time after two weeks in a different order Readers showing variation in performance will be retrained on interpretation of 4D MRI before reading scans for the study.
Once readers have been trained, the study will require that all 2D and 4D exams be read by two readers. The exams will be assigned randomly to readers using the Biostatistician Office random assignment services.
- Conditions
- Cardiac Disease
- Being tested
- Imaging software for 4 dimensional images for Cardiac MRI
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging software for 4 dimensional images for Cardiac MRIDevice
All enrollees will receive Cardiac MRI scans using Imaging software for 4 dimensional images for Cardiac MRI
| Study group | Role | What they receive |
|---|---|---|
| All Enrollees | Experimental | Intervention: Diagnostic test
All enrollees will receive a 4D MRI as a research intervention using imaging software for 4 dimensional images for Cardiac MRI Receives: Device: Imaging software for 4 dimensional images for Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
2D imaging findings and medical diagnoses resulting from images.
Investigators will count the number of study outcomes documented that are related to patient treatment.
Measured: Investigators are expected to interpret the 2D images in one sitting requiring 15 minutes to three hours, depending on exam complexity. The investigator will complete the scan review within 1 day to 1 month of the exam date.
4D imaging findings and medical diagnoses resulting from images.
Investigators will count the number of study outcomes documented that are related to patient treatment.
Measured: Investigators are expected to interpret the 4D images in one sitting requiring 15 minutes to three hours, depending on exam complexity. The investigator will complete the scan review within 1 day to 1 month of the exam date.
Secondary outcomes (10)
2D Time to scan acquisition
Investigators will document time to acquire 2D image.
Measured: The 2D scan time will be from the time the 2D patient scan starts to the time the 2D patient scan ends. These will be measured on the patient's scheduled scan date.
Time to 2D scan interpretation
Time to interpret 2-D scan interpretation will be from the time the reader starts reading the 2D scan until the time the reader finishes reading the 2D scan.
Measured: The time required for the reader to interpret scan for 2D and to document results. Within one month of scan completion. Reader is expected to interpret each scan in 1 to 3 hours.
Intra-reader reliability
Each reader will read each scan assigned on two different dates. The reader will be blind to identity of scan. The two readings will be compared for consistency.
Measured: The reader will record all findings from each scan immediately upon completion of scan interpretation. Findings should be recorded within a month of the exam.
Image quality
Overall measure of all scan image quality based on standard quality assessment protocol definitions.
Measured: The reader will record an image score for each exam during interpretation of the scan. The reader will record an image score within one month of scan completion date.
2D patient recommended treatments
The reader will document recommendations for patient treatment based on 2D imaging results
Measured: The reader will recommend follow-up patient care for each patient based upon completion of the exam interpretation. The reader will record all recommendations within one month of the exam.
90 day follow up
Describe patient follow-up. The interviewer will record the patient follow up by interviewing the patient within 90 to 120 days of the scan and asking what follow up was taken; and by medical record review. Follow up will be recorded and will be compared to recommended follow up.
Measured: The interviewer will contact patients with a target date of 90 to 120 days after the exam to obtain the followup information via telephone.
4D Time to scan acquisition
Investigators will document time to acquire 4D image
Measured: The 4D scan time will be from the time the 4D patient scan starts to the time the 4D patient scan ends. These will be measured on the patients scheduled scan date.
Time to 4D scan interpretation
Time to interpret 4D scan interpretation will be from the time the reader starts reading the 4D scan until the time the reader finishes reading the 4D scan.
Measured: The time required for the reader to interpret scan for 4D and to document results. Within one month of scan completion. Reader is expected to interpret each scan in 1 to 3 hours.
Inter-reader reliability
Two readers will read each scan. The readers will be blind to identity of scan. the reader will not know the results reported by the second reader. The two readings will be compared for consistency.
Measured: The reader will record all findings from each scan immediately upon completion of scan interpretation. Findings should be recorded within a month of the exam.
4D patient recommended treatments
The reader will document recommendations for patient treatment based on 4D imaging results
Measured: The reader will recommend follow-up patient care for each patient based upon completion of the exam interpretation. The reader will record all recommendations within one month of the exam.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start20 Feb 2018
- Primary completion26 Apr 2021
- Study completion20 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 Northwell HealthThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant will receive tradition 2D Cardiac imaging as ordered per standard of care. Then, the participant will receive a 4D image, requiring 6 to 10 additional minutes in the MRI scanner. The 2D and 4D images will be interpreted by readers blinded to the results of the alternate modality. Inter- and intra-reader reliability will be assessed.
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare, Arterys, Inc.
- Responsible party
- Principal investigator, Michael Poon, Northwell Health
- Investigators
- Michael Poon, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128268
- Sponsor's protocol ID
- 16-845-LHH
- Status last verified
- Oct 2022
- First submitted
- 3 Apr 2017
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Okada RD, Lim YL, Rothendler J, Boucher CA, Block PC, Pohost GM. Split dose thallium-201 dipyridamole imaging: a new technique for obtaining thallium images before and immediately after an intervention. J Am Coll Cardiol. 1983 May;1(5):1302-10. doi: 10.1016/s0735-1097(83)80144-2. No abstract available.
PubMed 6833669Vasanawala SS, Hanneman K, Alley MT, Hsiao A. Congenital heart disease assessment with 4D flow MRI. J Magn Reson Imaging. 2015 Oct;42(4):870-86. doi: 10.1002/jmri.24856. Epub 2015 Feb 24.
PubMed 25708923Hsiao A, Alley MT, Massaband P, Herfkens RJ, Chan FP, Vasanawala SS. Improved cardiovascular flow quantification with time-resolved volumetric phase-contrast MRI. Pediatr Radiol. 2011 Jun;41(6):711-20. doi: 10.1007/s00247-010-1932-z. Epub 2011 Jan 11.
PubMed 21221566Hsiao A, Lustig M, Alley MT, Murphy M, Chan FP, Herfkens RJ, Vasanawala SS. Rapid pediatric cardiac assessment of flow and ventricular volume with compressed sensing parallel imaging volumetric cine phase-contrast MRI. AJR Am J Roentgenol. 2012 Mar;198(3):W250-9. doi: 10.2214/AJR.11.6969.
PubMed 22358022Hsiao A, Lustig M, Alley MT, Murphy MJ, Vasanawala SS. Evaluation of valvular insufficiency and shunts with parallel-imaging compressed-sensing 4D phase-contrast MR imaging with stereoscopic 3D velocity-fusion volume-rendered visualization. Radiology. 2012 Oct;265(1):87-95. doi: 10.1148/radiol.12120055. Epub 2012 Aug 24.
PubMed 22923717Uretsky S, Gillam L, Lang R, Chaudhry FA, Argulian E, Supariwala A, Gurram S, Jain K, Subero M, Jang JJ, Cohen R, Wolff SD. Discordance between echocardiography and MRI in the assessment of mitral regurgitation severity: a prospective multicenter trial. J Am Coll Cardiol. 2015 Mar 24;65(11):1078-88. doi: 10.1016/j.jacc.2014.12.047.
PubMed 25790878Dyverfeldt P, Bissell M, Barker AJ, Bolger AF, Carlhall CJ, Ebbers T, Francios CJ, Frydrychowicz A, Geiger J, Giese D, Hope MD, Kilner PJ, Kozerke S, Myerson S, Neubauer S, Wieben O, Markl M. 4D flow cardiovascular magnetic resonance consensus statement. J Cardiovasc Magn Reson. 2015 Aug 10;17(1):72. doi: 10.1186/s12968-015-0174-5.
PubMed 26257141
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECTIVENESS OF 4D IMAGE ACQUISITION AND POST-PROCESSING WITH VIOS WORKS: A Phase Design Prospective Clinical Trial to Assess 4D Software Produced by GE and Arterys for Evaluating Cardiac Disease.
- ClinicalTrials.gov ID
- NCT03128268
- Acronym / sponsor ID
- 16-845-LHH
- Conditions
- Cardiac Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- GE Healthcare, Arterys, Inc.
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 20 Jun 2023 (estimated)
- First posted
- 25 Apr 2017 (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.
This study aims to evaluate the effectiveness of 4D image acquisition and post-processing with Vios Works for the evaluation of 3D images acquired on GE Magnetic Resonance Imaging scanners. Specifically, the investigators propose to evaluate the following:
- Image acquisition time using traditional 2D and new 4D processing techniques;
- Image quality for 2D and 4D processing techniques subjectively
- Post-processing time for the two techniques.
- Correlation of overall Left ventricular and right ventricular volumes and functions and aortic and pulmonic flow studies using the two techniques.
- The study will monitor any changes in patient diagnoses or treatment resulting from any differences in interpretations between the two processes.
Detailed description
Traditional scanning and post-processing of 2D Cardiac Magnetic Resonance images (CMRI) is highly technical and time consuming, with many exams requiring one to two hours to complete. In addition, performance of 2D scans often requires expert technologists working closely with the clinician imaging expert. These factors limit the general clinical utility of current generation cardiac MRI.
In order to address these factors, many researchers began to explore the use of 4D image acquisition and post processing to shorten exam time. These researchers have documented success at these efforts but, to the best of the current investigators' knowledge, such advanced imaging acquisition and post-processing systems are not readily commercially available in the US.
Recently GE teamed with Vios-Works for MRI to provide a cloud-based visualization platform for 4D MRI that provides quantitative and structured reporting in the post processing environment that makes use of advance MR imaging acquisition techniques. The images can be accessed by the interpreter and reviewed and manipulated in order to assess cardiac function and flow retrospectively, which, prior to this innovation, only has been available for computed tomography (CT) generated images.
This investigative team hypothesizes that the use of 4D imaging will result in reduced time for acquisition (approximately 6 minutes as opposed to 1 hour), and improvement of diagnostic capability.
Images will be acquired using the current standard 2D acquisition protocol for routine clinical cardiac MRI. A repeat acquisition will be completed using the new protocol for 4D imaging acquisition. This will require that patient exams be extended in length by six minutes for those enrolled in the study. The investigators will evaluate the image quality of the two techniques and grade them according to a scale of 1 to 3 with 1 being excellent cardiac borders easily identified; 2 - acceptable: cardiac borders acceptably identified; and 3, non-diagnostic. The investigators will specifically focus on the evaluation of cardiac function of both right and left ventricular function as well as flow analysis of both the aortic and pulmonic valves.
For each method, technician time and MD time will be collected. The exam will go through post processing for standard 2D, following by the new 4D post processing technique. Time for post processing will be collected. All subjects who agree will receive both a 2D and a 4D MRI. The investigators will evaluate inter and intra reader reliability by having all readers read the first 15 exams, and then read them a second time after two weeks in a different order Readers showing variation in performance will be retrained on interpretation of 4D MRI before reading scans for the study.
Once readers have been trained, the study will require that all 2D and 4D exams be read by two readers. The exams will be assigned randomly to readers using the Biostatistician Office random assignment services.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant will receive tradition 2D Cardiac imaging as ordered per standard of care. Then, the participant will receive a 4D image, requiring 6 to 10 additional minutes in the MRI scanner. The 2D and 4D images will be interpreted by readers blinded to the results of the alternate modality. Inter- and intra-reader reliability will be assessed.
| Arm | Type | Receives |
|---|---|---|
| All Enrollees | Experimental | Device: Imaging software for 4 dimensional images for Cardiac MRIIntervention: Diagnostic test All enrollees will receive a 4D MRI as a research intervention using imaging software for 4 dimensional images for Cardiac MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- with a valid prescription for Cardiac MRI for the following: Congenital heart disease/Shunts, Valvular heart disease, Pulmonary Hypertension, Aortic Disease, Hypertrophic Cardiomyopathy (HCM)
- receiving Standard of Care services at the MRI Center
- consent to participate in the 4D trial
Key exclusion criteria (9 listed)
- Pacemaker or ICD implanted
- ICDs implanted
- Temporary Pacemakers (e.g. transvenous temporary wires)
- Leads that are abandoned (capped or retained leads not attached to device)
- Non-transvenous leads (e.g. epicardial leads)
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 |
|---|---|---|
| Imaging software for 4 dimensional images for Cardiac MRIAll enrollees will receive Cardiac MRI scans using Imaging software for 4 dimensional images for Cardiac MRI | Device | All Enrollees |
Primary outcome
2D imaging findings and medical diagnoses resulting from images.
Time frame: Investigators are expected to interpret the 2D images in one sitting requiring 15 minutes to three hours, depending on exam complexity. The investigator will complete the scan review within 1 day to 1 month of the exam date.
Investigators will count the number of study outcomes documented that are related to patient treatment.
4D imaging findings and medical diagnoses resulting from images.
Time frame: Investigators are expected to interpret the 4D images in one sitting requiring 15 minutes to three hours, depending on exam complexity. The investigator will complete the scan review within 1 day to 1 month of the exam date.
Investigators will count the number of study outcomes documented that are related to patient treatment.
10 secondary outcomes
2D Time to scan acquisition
Time frame: The 2D scan time will be from the time the 2D patient scan starts to the time the 2D patient scan ends. These will be measured on the patient's scheduled scan date.
Time to 2D scan interpretation
Time frame: The time required for the reader to interpret scan for 2D and to document results. Within one month of scan completion. Reader is expected to interpret each scan in 1 to 3 hours.
Intra-reader reliability
Time frame: The reader will record all findings from each scan immediately upon completion of scan interpretation. Findings should be recorded within a month of the exam.
Image quality
Time frame: The reader will record an image score for each exam during interpretation of the scan. The reader will record an image score within one month of scan completion date.
2D patient recommended treatments
Time frame: The reader will recommend follow-up patient care for each patient based upon completion of the exam interpretation. The reader will record all recommendations within one month of the exam.
90 day follow up
Time frame: The interviewer will contact patients with a target date of 90 to 120 days after the exam to obtain the followup information via telephone.
4D Time to scan acquisition
Time frame: The 4D scan time will be from the time the 4D patient scan starts to the time the 4D patient scan ends. These will be measured on the patients scheduled scan date.
Time to 4D scan interpretation
Time frame: The time required for the reader to interpret scan for 4D and to document results. Within one month of scan completion. Reader is expected to interpret each scan in 1 to 3 hours.
Inter-reader reliability
Time frame: The reader will record all findings from each scan immediately upon completion of scan interpretation. Findings should be recorded within a month of the exam.
4D patient recommended treatments
Time frame: The reader will recommend follow-up patient care for each patient based upon completion of the exam interpretation. The reader will record all recommendations within one month of the exam.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Background: PubMed 6833669Okada RD, Lim YL, Rothendler J, Boucher CA, Block PC, Pohost GM. Split dose thallium-201 dipyridamole imaging: a new technique for obtaining thallium images before and immediately after an intervention. J Am Coll Cardiol. 1983 May;1(5):1302-10. doi: 10.1016/s0735-1097(83)80144-2. No abstract available.
- Background: PubMed 25708923Vasanawala SS, Hanneman K, Alley MT, Hsiao A. Congenital heart disease assessment with 4D flow MRI. J Magn Reson Imaging. 2015 Oct;42(4):870-86. doi: 10.1002/jmri.24856. Epub 2015 Feb 24.
- Background: PubMed 21221566Hsiao A, Alley MT, Massaband P, Herfkens RJ, Chan FP, Vasanawala SS. Improved cardiovascular flow quantification with time-resolved volumetric phase-contrast MRI. Pediatr Radiol. 2011 Jun;41(6):711-20. doi: 10.1007/s00247-010-1932-z. Epub 2011 Jan 11.
- Background: PubMed 22358022Hsiao A, Lustig M, Alley MT, Murphy M, Chan FP, Herfkens RJ, Vasanawala SS. Rapid pediatric cardiac assessment of flow and ventricular volume with compressed sensing parallel imaging volumetric cine phase-contrast MRI. AJR Am J Roentgenol. 2012 Mar;198(3):W250-9. doi: 10.2214/AJR.11.6969.
- Background: PubMed 22923717Hsiao A, Lustig M, Alley MT, Murphy MJ, Vasanawala SS. Evaluation of valvular insufficiency and shunts with parallel-imaging compressed-sensing 4D phase-contrast MR imaging with stereoscopic 3D velocity-fusion volume-rendered visualization. Radiology. 2012 Oct;265(1):87-95. doi: 10.1148/radiol.12120055. Epub 2012 Aug 24.
- Background: PubMed 25790878Uretsky S, Gillam L, Lang R, Chaudhry FA, Argulian E, Supariwala A, Gurram S, Jain K, Subero M, Jang JJ, Cohen R, Wolff SD. Discordance between echocardiography and MRI in the assessment of mitral regurgitation severity: a prospective multicenter trial. J Am Coll Cardiol. 2015 Mar 24;65(11):1078-88. doi: 10.1016/j.jacc.2014.12.047.
- Background: PubMed 26257141Dyverfeldt P, Bissell M, Barker AJ, Bolger AF, Carlhall CJ, Ebbers T, Francios CJ, Frydrychowicz A, Geiger J, Giese D, Hope MD, Kilner PJ, Kozerke S, Myerson S, Neubauer S, Wieben O, Markl M. 4D flow cardiovascular magnetic resonance consensus statement. J Cardiovasc Magn Reson. 2015 Aug 10;17(1):72. doi: 10.1186/s12968-015-0174-5.
- 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.
Michael Poon, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaging software for 4 dimensional images for Cardiac MRI in people with Cardiac Disease, run by Northwell Health 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 4 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2022. 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?
This study is still under way. Results are not available in the source record yet.
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?
2D imaging findings and medical diagnoses resulting from images. (time frame: Investigators are expected to interpret the 2D images in one sitting requiring 15 minutes to three hours, depending on exam complexity. The investigator will complete the scan review within 1 day to 1 month of the exam date.). The study lists 2 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 NCT03128268, which also lists 7 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 26 Oct 2022; AzTrials last refreshed its copy on 3 Nov 2026.