Acute Graft RejectionNCT02266914

Magnetic Resonance Elastography of Cardiac Transplant Rejection

A study testing Magnetic Resonance Elastography driver in people with Acute Graft Rejection, run by Ohio State University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Magnetic Resonance Elastography (MRE) for cardiac transplant patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Graft Rejection
What is being tested?: Magnetic Resonance Elastography driver
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: 27 Jan 2014to 1 Dec 2017
Phase: Interventional
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

Patients must have undergone cardiac transplantation at the Ohio State University Ross Heart Hospital.
Patients must be able to lie flat on their back in the scanner for up to 60 minutes
Patient must be able to hold their breath for up to 15 seconds at a time.

Who cannot join

Patients who are claustrophobic
Patients who are pregnant, due to potential risks to the fetus.
Patients with any unapproved, non-MRI safe metal/devices in their bodies.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Ohio State University Medical Center
Columbus, Ohio, 43210

Other trials in United States

About this study

Magnetic Resonance Elastography (MRE) for cardiac transplant patients.

Read the detailed description

Patient will undergo MRE beginning 4-8 weeks post transplant, then with each scheduled cardiac biopsy through 7-8 months post transplant. Results of the MRE will be compared against results of the cardiac biopsy to determine if the non-invasive MRE can predict cardiac transplant rejection.

Conditions: Acute Graft Rejection
Being tested: Magnetic Resonance Elastography driver

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Magnetic Resonance Elastography driverDevice
Also called Siemens MRE Driver
A driver is required for MRE. The driver utilizes sound waves to produce vibrations. Images of these vibrations are captured with Magnetic Resonance scanner to produce images that indicate stiffness in an organ.

Study groups in NCT02266914
Study group	Role	What they receive
Arm 1	Experimental	Patients who have received a cardiac transplant at The Ohio State University Ross Heart Hospital will undergo Magnetic Resonance Elastography (MRE) (using a Magnetic Resonance Elastography driver) within 24-48 hours of standard of care biopsy. Results of both will be compared to determine if MRE can successfully predict cardiac transplant rejection. Receives: Device: Magnetic Resonance Elastography driver

What is being measured

The primary outcome is the main question the study is designed to answer.

Cardiac Stiffness With Magnetic Resonance Elastography (MRE)
MRE scans will be performed within 24-48 hours of standard of care cardiac biopsies for patients who have undergone cardiac transplant at The Ohio State University Ross Heart Hospital. Stiffness results from the MRE will be compared to histopathology from the cardiac biopsy to determine if the completely non-invasive MRE can successfully predict transplant rejection.
Measured: 24-48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jan 20141 Dec 2017

First posted17 Oct 2014 (estimated)
Study start27 Jan 2014
Primary completion1 Dec 2017
Study completion1 Dec 2017

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 Acute Graft RejectionStudies of the same condition, open and under way.
More trials run by Ohio State 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 N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02266914
Sponsor's protocol ID: 2013H0318
Status last verified: May 2019
First submitted: 30 Sep 2014
Last updated: 22 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Study of LBP-MARCO and Ruxolitinib in People With Graft-Versus-Host Disease (GVHD)
Transplant Failure or Rejection of Bone Marrow (Graft vs Host Disease, GVHD)
RecruitingEarly Phase 1
Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Bone Marrow or Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies
Hematologic Malignancy, Bone Marrow Transplant Rejection
Active, not recruitingObservational study
Extended Validation of Donor-derived Cell-free DNA in Kidney Transplant Recipients
Rejection Acute Renal, Rejection Chronic Renal
RecruitingPhase 3
A Multicenter Randomized Controlled Trial to Treat Acute T Cell Mediated Rejection in Kidney and Kidney-Pancreas Transplant Recipients
Rejection; Transplant, Kidney, Rejection; Transplant, Pancreas
RecruitingObservational study
Dd-cfDNA and Treg in Prediction of Kidney Transplant Acute Rejection
Acute Rejection of Renal Transplant, Graft Failure

All Acute Graft Rejection trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Magnetic Resonance Elastography of Cardiac Transplant Rejection
ClinicalTrials.gov ID: NCT02266914
Acronym / sponsor ID: 2013H0318
Conditions: Acute Graft Rejection
Study type: Interventional
Recruitment status: Terminated
Enrolment: 9 participants (actual)
Lead sponsor: Ohio State UniversityUniversity, hospital or other
Study start: 27 Jan 2014 (actual)
Primary completion: 1 Dec 2017 (actual)
Study completion: 1 Dec 2017 (actual)
First posted: 17 Oct 2014 (estimated)
Results: Posted 22 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Magnetic Resonance Elastography (MRE) for cardiac transplant patients.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Arm 1	Experimental	Device: Magnetic Resonance Elastography driverPatients who have received a cardiac transplant at The Ohio State University Ross Heart Hospital will undergo Magnetic Resonance Elastography (MRE) (using a Magnetic Resonance Elastography driver) within 24-48 hours of standard of care biopsy. Results of both will be compared to determine if MRE can successfully predict cardiac transplant rejection.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients must have undergone cardiac transplantation at the Ohio State University Ross Heart Hospital.
Patients must be able to lie flat on their back in the scanner for up to 60 minutes
Patient must be able to hold their breath for up to 15 seconds at a time.

Key exclusion criteria (3 listed)

Patients who are claustrophobic
Patients who are pregnant, due to potential risks to the fetus.
Patients with any unapproved, non-MRI safe metal/devices in their bodies.

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
Magnetic Resonance Elastography driverAlso: Siemens MRE DriverA driver is required for MRE. The driver utilizes sound waves to produce vibrations. Images of these vibrations are captured with Magnetic Resonance scanner to produce images that indicate stiffness in an organ.	Device	Arm 1

Primary outcome

Cardiac Stiffness With Magnetic Resonance Elastography (MRE)
Time frame: 24-48 hours
MRE scans will be performed within 24-48 hours of standard of care cardiac biopsies for patients who have undergone cardiac transplant at The Ohio State University Ross Heart Hospital. Stiffness results from the MRE will be compared to histopathology from the cardiac biopsy to determine if the completely non-invasive MRE can successfully predict transplant rejection.

Results and safety

Results posted to the registry on 22 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cardiac Transplant Patients	9	0

Primary outcome: Cardiac Stiffness With Magnetic Resonance Elastography (MRE)

Time frame: 24-48 hours

Population analysed: Data were not collected due to study termination.

Adverse events

Time frame: 1 year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cardiac Transplant Patients	0 of 9 (0%)	0 of 9 (0%)	1 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Acute Graft Rejection

RecruitingPhase 1
A Study of LBP-MARCO and Ruxolitinib in People With Graft-Versus-Host Disease (GVHD)
Transplant Failure or Rejection of Bone Marrow (Graft vs Host Disease, GVHD)
RecruitingEarly Phase 1
Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Bone Marrow or Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies
Hematologic Malignancy, Bone Marrow Transplant Rejection
Active, not recruitingObservational study
Extended Validation of Donor-derived Cell-free DNA in Kidney Transplant Recipients
Rejection Acute Renal, Rejection Chronic Renal
RecruitingPhase 3
A Multicenter Randomized Controlled Trial to Treat Acute T Cell Mediated Rejection in Kidney and Kidney-Pancreas Transplant Recipients
Rejection; Transplant, Kidney, Rejection; Transplant, Pancreas
RecruitingObservational study
Dd-cfDNA and Treg in Prediction of Kidney Transplant Acute Rejection
Acute Rejection of Renal Transplant, Graft Failure

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.

Richard White, MD principal investigator

The Ohio State University Medical Center Dept. of Radiology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Magnetic Resonance Elastography driver in people with Acute Graft Rejection, run by Ohio State 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 3 inclusion and 3 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 22 May 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?

Yes. Results are posted in the registry (first posted 22 May 2019). 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?

Cardiac Stiffness With Magnetic Resonance Elastography (MRE) (time frame: 24-48 hours). 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 NCT02266914.

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 22 May 2019.