Heart TransplantationNCT02300870
Myocardial Perfusion Echocardiography to Detect Human Heart Transplant Rejection
An observational study of Heart Transplantation, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The primary objective of this proposal is to show the efficacy of contrast enhanced ultrasonography in detecting heart transplant rejection in humans. The secondary objective is to demonstrate the efficacy of this technique in generating data which allow for the assessment of short and long term outcomes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Transplantation
- What is being tested?
- Optison
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart Transplant patients
Who may be able to join
- All adult subjects (ages 18 to 75) who have undergone heart transplant at Brigham and Women's Hospital
Who cannot join
- hemodynamic instability (e.g., systolic blood pressure < 90 mmHg)
- atrial fibrillation with rapid ventricular response (e.g., heart rate > 120 bpm)
- premature atrial or ventricular complexes of a frequency that will not allow adequate echocardiographic assessment
- poor acoustic windows
- inability to provide informed consent
- any contraindication listed in the Optison package insert (i.e., history of an allergic reaction)
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Myocardial Perfusion Echocardiography to Detect Human Heart Transplant
The primary objective of this proposal is to show the efficacy of contrast enhanced ultrasonography in detecting heart transplant rejection in humans. The secondary objective is to demonstrate the efficacy of this technique in generating data which allow for the assessment of short and long term outcomes.
- Conditions
- Heart Transplantation
- Being tested
- Optison
- Keywords
- Acute rejection, myocardial blood flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptisonDrug
Also called Echocontrast agent
Echocardiogram with IV contrast
| Study group | Role | What they receive |
|---|---|---|
| Heart Transplant Rejection | Patients presenting with acute cellular rejection Receives: Drug: Optison | |
| Heart Transplant Control | Patients presenting for routine office visit Receives: Drug: Optison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global and regional microvascular myocardial perfusion
Myocardial blood flow (dB/s)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2019
- Study completionDec 2019
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 Brigham and Women's HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- General Electric
- Responsible party
- Principal investigator, Michael Givertz, MD, Brigham and Women's Hospital
- Investigators
- Michael Givertz, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300870
- Sponsor's protocol ID
- BWHMG370000
- Status last verified
- Jul 2023
- First submitted
- 17 Nov 2014
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Perfusion Echocardiography to Detect Human Heart Transplant
- ClinicalTrials.gov ID
- NCT02300870
- Acronym / sponsor ID
- BWHMG370000
- Conditions
- Heart Transplantation
- Keywords
- Acute rejection, myocardial blood flow
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- General Electric
- Study start
- Jan 2015
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 25 Nov 2014 (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.
The primary objective of this proposal is to show the efficacy of contrast enhanced ultrasonography in detecting heart transplant rejection in humans. The secondary objective is to demonstrate the efficacy of this technique in generating data which allow for the assessment of short and long term outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart Transplant Rejection | – | Drug: OptisonPatients presenting with acute cellular rejection |
| Heart Transplant Control | – | Drug: OptisonPatients presenting for routine office visit |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart Transplant patients
Key inclusion criteria (1 listed)
- All adult subjects (ages 18 to 75) who have undergone heart transplant at Brigham and Women's Hospital
Key exclusion criteria (6 listed)
- hemodynamic instability (e.g., systolic blood pressure < 90 mmHg)
- atrial fibrillation with rapid ventricular response (e.g., heart rate > 120 bpm)
- premature atrial or ventricular complexes of a frequency that will not allow adequate echocardiographic assessment
- poor acoustic windows
- inability to provide informed consent
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 |
|---|---|---|
| OptisonAlso: Echocontrast agentEchocardiogram with IV contrast | Drug | Heart Transplant Control, Heart Transplant Rejection |
Primary outcome
Global and regional microvascular myocardial perfusion
Time frame: Baseline
Myocardial blood flow (dB/s)
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 27 Jul 2023.
- 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 Givertz, MD principal investigator
Brigham and Women's Hospital
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 Heart Transplantation, run by Brigham and Women's Hospital 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 1 inclusion and 6 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 27 Jul 2023. 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?
Global and regional microvascular myocardial perfusion (time frame: Baseline). 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 27 Jul 2023.