HealthyNCT02012725
Molecular MRI of the Fibrotic Heart
An observational study of Healthy and Myocardial Fibrosis, run by Moriel Vandsburger at 1 site in United States.
Trial summary
This study is a feasibility study to validate magnetizatin transfer (MT)-weighted balanced steady state free precession (bSSFP) cine cardiac magnetic resonance (CMR) against current clinical gold standard diagnostics, and to determine the applicability of MT-weighted bSSFP cine CMR for diagnosis of fibrotic remodeling… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Myocardial Fibrosis, Chronic Kidney Disease
- What is being tested?
- Arm 1 MRI with gadolinium
- Type of treatment
- Injection or infusion
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 1 May 2017
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants taking part in this study will be: * Referred from the University of Kentucky Gill Heart Institute (planned enrollment for this group is 100 patients) * Referred from another study on chronic kidney disease (planned enrollment for this group is 100 patients and 50 healthy volunteers)
Who may be able to join
- Participants between the ages of 20 and 80
- Diagnosis or suspicion of myocardial fibrosis
- Referral for LGE-CMR
- Participants between the ages of 20 and 80
- History of between 1-10 years of routine hemodialysis
- Healthy Volunteers
Who cannot join
- Confirmed acute MI within the prior 72 hours
- Unstable ECG or arrhythmia as determined by the referring physician
- Inability to hold one's breath for at least 10 seconds
- Standard MRI safety exclusion criteria
- Allergic reaction to Gadolinium
- Women who are pregnant, think they are pregnant or who breastfeeding
Show all 11Show fewer
- Arm 2
- Confirmed acute myocardial infarction within the prior 72 hours
- Unstable ECG or arrhythmia
- Inability to hold one's breath for at least 10 seconds
- Standard MRI safety exclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Medical Center
Lexington, Kentucky, 40536
About this study
This study is a feasibility study to validate magnetizatin transfer (MT)-weighted balanced steady state free precession (bSSFP) cine cardiac magnetic resonance (CMR) against current clinical gold standard diagnostics, and to determine the applicability of MT-weighted bSSFP cine CMR for diagnosis of fibrotic remodeling in chronic kidney disease (CKD5) patients. Participants will not receive a study drug or placebo and will not be randomized. A total of 250 participants will be enrolled into this study.
Read the detailed description
This study had two treatment arms.
Arm 1: Participants will be enrolled in this arm if they have been referred to the Gill Heart Institute MRI center for diagnostic late gadolinium enhancement (LGE) -CMR imaging of fibrosis, or if they are a healthy volunteer.
If a participant is a Gill Heart Institute referral patient , they will receive an intravenous (through a vein in the arm) infusion of gadolinium as part of their clinical examination. Participants will also have electrocardiogram (ECG) waveform performed in order to gate the MRI scan. The MRI scan of the heart, for which the participant has been referred will last approximately 1 hour. Participants will have an additional 5-10 minutes of scans performed, none of which require additional infusions.
If the participant is a healthy volunteer, they will have an ECG waveform performed in order to gate your MRI scan, and they will have approximately 30-45 minutes of scanning performed on their heart. Participants will not receive an infusion of gadolinium.
Arm 2: Only participants who are already participating in a study being conducted by Dr. Harmut Malluche at the University of Kentucky, Department of Nephrology or, if you are a healthy volunteer, will be enrolled into this arm.
In this arm participants will receive an MRI of their heart, lasting 30-45 minutes. Participants will not receive an infusion of gadolinium.
- Conditions
- Healthy, Myocardial Fibrosis, Chronic Kidney Disease
- Being tested
- Arm 1 MRI with gadolinium
- Keywords
- Healthy, Myocardial fibrosis, Chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1 MRI with gadoliniumDrug
Healthy volunteers will not receive gadolinium
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Mycardial Fibrosis | MRI with Intravenous administration of gadolinium Receives: Drug: Arm 1 MRI with gadolinium | |
| Arm 2 Chronic Kidney Disease | MRI with no gadolinium administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm 1 - Validation of gadolinium free fibrosis imaging against current standard of care LGE-CMR
Results from this arm will focus on validating cine FI measured from MT-weighted bSSFP cine CMR against LGE-CMR and MOLLI characterization of fibrosis in patients referred to the Gill Heart Institute.
Measured: 36 months
Arm 2 - Imaging of myocardial fibrosis in CKD patients
Will test the hypothesis that MT-weighted CMR can be applied to identify fibrotic remodeling in the hearts of CKD5 patients
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startJan 2014
- Primary completion1 May 2017
- Study completion1 May 2017
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moriel Vandsburger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Moriel Vandsburger, University of Kentucky
- Investigators
- Moriel Vandsburger, PhD, Principal investigator, University of Kentucky, Department of Physiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012725
- Sponsor's protocol ID
- 5KL2TR000116-03
- Status last verified
- Jan 2018
- First submitted
- 6 Dec 2013
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular MRI of the Fibrotic Heart
- ClinicalTrials.gov ID
- NCT02012725
- Acronym / sponsor ID
- 5KL2TR000116-03
- Conditions
- Healthy, Myocardial Fibrosis, Chronic Kidney Disease
- Keywords
- Healthy, Myocardial fibrosis, Chronic kidney disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left institution
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Moriel VandsburgerUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 16 Dec 2013 (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.
This study is a feasibility study to validate magnetizatin transfer (MT)-weighted balanced steady state free precession (bSSFP) cine cardiac magnetic resonance (CMR) against current clinical gold standard diagnostics, and to determine the applicability of MT-weighted bSSFP cine CMR for diagnosis of fibrotic remodeling in chronic kidney disease (CKD5) patients. Participants will not receive a study drug or placebo and will not be randomized. A total of 250 participants will be enrolled into this study.
Detailed description
This study had two treatment arms.
Arm 1: Participants will be enrolled in this arm if they have been referred to the Gill Heart Institute MRI center for diagnostic late gadolinium enhancement (LGE) -CMR imaging of fibrosis, or if they are a healthy volunteer.
If a participant is a Gill Heart Institute referral patient , they will receive an intravenous (through a vein in the arm) infusion of gadolinium as part of their clinical examination. Participants will also have electrocardiogram (ECG) waveform performed in order to gate the MRI scan. The MRI scan of the heart, for which the participant has been referred will last approximately 1 hour. Participants will have an additional 5-10 minutes of scans performed, none of which require additional infusions.
If the participant is a healthy volunteer, they will have an ECG waveform performed in order to gate your MRI scan, and they will have approximately 30-45 minutes of scanning performed on their heart. Participants will not receive an infusion of gadolinium.
Arm 2: Only participants who are already participating in a study being conducted by Dr. Harmut Malluche at the University of Kentucky, Department of Nephrology or, if you are a healthy volunteer, will be enrolled into this arm.
In this arm participants will receive an MRI of their heart, lasting 30-45 minutes. Participants will not receive an infusion of gadolinium.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Mycardial Fibrosis | – | Drug: Arm 1 MRI with gadoliniumMRI with Intravenous administration of gadolinium |
| Arm 2 Chronic Kidney Disease | – | –MRI with no gadolinium administration |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants taking part in this study will be: * Referred from the University of Kentucky Gill Heart Institute (planned enrollment for this group is 100 patients) * Referred from another study on chronic kidney disease (planned enrollment for this group is 100 patients and 50 healthy volunteers)
Key inclusion criteria (6 listed)
- Participants between the ages of 20 and 80
- Diagnosis or suspicion of myocardial fibrosis
- Referral for LGE-CMR
- Participants between the ages of 20 and 80
- History of between 1-10 years of routine hemodialysis
Key exclusion criteria (11 listed)
- Confirmed acute MI within the prior 72 hours
- Unstable ECG or arrhythmia as determined by the referring physician
- Inability to hold one's breath for at least 10 seconds
- Standard MRI safety exclusion criteria
- Allergic reaction to Gadolinium
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 |
|---|---|---|
| Arm 1 MRI with gadoliniumHealthy volunteers will not receive gadolinium | Drug | Arm 1 Mycardial Fibrosis |
Primary outcome
Arm 1 - Validation of gadolinium free fibrosis imaging against current standard of care LGE-CMR
Time frame: 36 months
Results from this arm will focus on validating cine FI measured from MT-weighted bSSFP cine CMR against LGE-CMR and MOLLI characterization of fibrosis in patients referred to the Gill Heart Institute.
Arm 2 - Imaging of myocardial fibrosis in CKD patients
Time frame: 48 months
Will test the hypothesis that MT-weighted CMR can be applied to identify fibrotic remodeling in the hearts of CKD5 patients
Results and safety
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
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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.
Moriel Vandsburger, PhD principal investigator
University of Kentucky, Department of Physiology
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 Healthy and Myocardial Fibrosis, run by Moriel Vandsburger 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 6 inclusion and 11 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 2018. 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 (reason given: PI left institution). 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?
Arm 1 - Validation of gadolinium free fibrosis imaging against current standard of care LGE-CMR (time frame: 36 months). 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?
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 2018.