Heart TransplantationPhase 3NCT00169936
Magnetocardiography as a Non-Invasive Tool for Detecting Tissue Rejection in Heart Transplant Patients
A Phase 3 study testing Magnetocardiograph in people with Heart Transplantation, run by Mayo Clinic at 1 site in United States.
Trial summary
Heart transplantation is a great procedure for selected patients with end-stage heart failure, but graft rejection remains a major factor limiting long-term survival despite continued advancement in the scientific skill of immunosuppression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplantation
- What is being tested?
- Magnetocardiograph
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Jan 2007
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult heart transplant recipients referred for surveillance biopsies
- Age greater than 18 years old
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Magnetocardiography as a Tool for Non-invasive Detection of Tissue Rejection in Cardiac Transplant Recipients
Heart transplantation is a great procedure for selected patients with end-stage heart failure, but graft rejection remains a major factor limiting long-term survival despite continued advancement in the scientific skill of immunosuppression. The only reliable method used today to detect rejection is doing repeated biopsy of the heart. This is expensive, invasive, inconvenient to the patient, and associated with a significant risk of serious complications, as a piece directly from the inner surface of the patients heart is needed. The magnetocardiograph (MCG) device is an invention that may provide new means to assess changes in the heart tissue, as it may detect small changes that happen in the heart cells when they are undergoing rejection.
Read the detailed description
Heart transplantation is an advantageous procedure for selected patients with end-stage heart failure. Graft rejection remains a major factor limiting long-term survival despite continued advancement in the scientific skill of immunosuppression. Hyperacute rejection occurs rarely since screening of recipient for anti-donor antibodies was introduced. Focal or diffuse acute cellular rejection is diagnosed by endomyocardial biopsy (EMB). Coronary angiography (CA) is used to monitor for allograft arteriopathy, also described as chronic rejection. Repeated endomyocardial biopsy (EMB) remains the only surveillance method available. Endomyocardial biopsy is expensive, invasive, inconvenient to the patient, and associated with a significant incidence of serious complications. The MCG device is an invention that may provide a sensitive and objective means to assess alterations in the heart tissue. Because the acute inflammatory process of rejection deleteriously affects myocyte structure and function, we hypothesize that either or both the de- and re-polarization changes will occur in the cardiac cycle with subsequent changes in the cardiac magnetic fields and may give altered readings in the affected patient over time.
- Conditions
- Heart Transplantation
- Being tested
- Magnetocardiograph
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnetocardiographDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the magnetocardiographic changes in de- and/or re-polarization patterns in patients with tissue rejection relative to initial MCG reading obtained during no rejection.
Secondary outcomes (2)
Determine the reproducibility of the MCG between two different recordings performed at times when rejection is histologically absent (grade 0-endomyocardial biopsy).
Differentiate the MCG results between time of grade 0 biopsy and that of the different rejection grades.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- CardioMag Imaging
- Investigators
- Peter A Smars, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169936
- Sponsor's protocol ID
- 20-05
- Status last verified
- Jan 2010
- First submitted
- 12 Sep 2005
- Last updated
- 28 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Magnetocardiography as a Tool for Non-invasive Detection of Tissue Rejection in Cardiac Transplant Recipients
- ClinicalTrials.gov ID
- NCT00169936
- Acronym / sponsor ID
- 20-05
- Conditions
- Heart Transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- CardioMag Imaging
- Study start
- Dec 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 15 Sep 2005 (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.
Heart transplantation is a great procedure for selected patients with end-stage heart failure, but graft rejection remains a major factor limiting long-term survival despite continued advancement in the scientific skill of immunosuppression. The only reliable method used today to detect rejection is doing repeated biopsy of the heart. This is expensive, invasive, inconvenient to the patient, and associated with a significant risk of serious complications, as a piece directly from the inner surface of the patients heart is needed. The magnetocardiograph (MCG) device is an invention that may provide new means to assess changes in the heart tissue, as it may detect small changes that happen in the heart cells when they are undergoing rejection.
Detailed description
Heart transplantation is an advantageous procedure for selected patients with end-stage heart failure. Graft rejection remains a major factor limiting long-term survival despite continued advancement in the scientific skill of immunosuppression. Hyperacute rejection occurs rarely since screening of recipient for anti-donor antibodies was introduced. Focal or diffuse acute cellular rejection is diagnosed by endomyocardial biopsy (EMB). Coronary angiography (CA) is used to monitor for allograft arteriopathy, also described as chronic rejection. Repeated endomyocardial biopsy (EMB) remains the only surveillance method available. Endomyocardial biopsy is expensive, invasive, inconvenient to the patient, and associated with a significant incidence of serious complications. The MCG device is an invention that may provide a sensitive and objective means to assess alterations in the heart tissue. Because the acute inflammatory process of rejection deleteriously affects myocyte structure and function, we hypothesize that either or both the de- and re-polarization changes will occur in the cardiac cycle with subsequent changes in the cardiac magnetic fields and may give altered readings in the affected patient over time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult heart transplant recipients referred for surveillance biopsies
- Age greater than 18 years old
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Magnetocardiograph | Device | – |
Primary outcome
Determine the magnetocardiographic changes in de- and/or re-polarization patterns in patients with tissue rejection relative to initial MCG reading obtained during no rejection.
2 secondary outcomes
Determine the reproducibility of the MCG between two different recordings performed at times when rejection is histologically absent (grade 0-endomyocardial biopsy).
Differentiate the MCG results between time of grade 0 biopsy and that of the different rejection grades.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2010.
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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.
Peter A Smars, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Magnetocardiograph in people with Heart Transplantation, run by Mayo Clinic 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 0 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 28 Jan 2010. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine the magnetocardiographic changes in de- and/or re-polarization patterns in patients with tissue rejection relative to initial MCG reading obtained during no rejection.. 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 28 Jan 2010.