A Phase 4 interventional study of Perflutren Lipid Microsphere and RTMPE in Cardiac Allograft Vasculopathy, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2019-06-20.
Sponsored by Mayo Clinic · Phase 4, Interventional, and Diagnostic
Is real-time myocardial perfusion echocardiography (RTMPE) a feasible and effective non-invasive method to detect significant Coronary Allograft Vasculopathy in pediatric and adult cardiac transplant recipients? Will perfusion deficits correlate with significant coronary artery stenosis identified by standard stress echocardiography and Invasive Coronary Angiography (ICA), and identify diffuse small vessel disease more effectively than current non-invasive techniques?
Heart transplant recipients are susceptible to developing a unique disease that causes blockages in the arteries of the transplanted heart (coronary arteries) called Coronary Allograft Vasculopathy (CAV). Because CAV often progresses without symptoms, transplant recipients undergo regular surveillance testing so that CAV can be detected and treatment can be offered before significant damage to the transplanted heart occurs. Current tests used to detect CAV are either invasive (with risk of complications) or may not be able to detect CAV in its early stages. Myocardial contrast perfusion echocardiography is a safe non-invasive diagnostic test that may be well suited for detecting CAV, however has not been well studied in heart transplant recipients. This study examines the ability of myocardial contrast perfusion echocardiography to detect CAV in adult and pediatric heart transplant recipients, and compare those results to current standard testing strategies such as Invasive Coronary Angiography (ICA) and standard stress echocardiography. This will help determine whether myocardial contrast perfusion echocardiography is a better test for regular surveillance of CAV in adult and pediatric transplant recipients.
1,027 studies on the registry are indexed under Vascular Diseases; 167 are open to participants now.
This study's enrollment of 36 is below the median of 78 across 639 interventional studies indexed under Vascular Diseases.
Browse Vascular Diseases studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion:
RTMPE with Perflutren Lipid Microsphere (DEFINITY) is a safe and feasible non-invasive technique commonly used to diagnose coronary disease, and offers an attractive alternative for CAV detection.
Drug: Perflutren Lipid Microsphere · Procedure: RTMPE
Definity (injectible suspension ultrasound contrast agent) will be diluted with saline for both Pediatric and Adult subjects. For pediatric subjects under 60kg (kilogram), the dose will be 20 MicroL/kg (MicroLiter/kilogram) diluted to the same concentration used in the adult dosing. Hand Injections will be performed at baseline, Pre-peak, and peak perfusion stages.
Also known as: Definity
Utilizes intravenous administration of biologically-inert microbubbles to assess myocardial perfusion and has demonstrated utility for identifying small vessel coronary artery disease.
Also known as: Real Time Myocardial Perfusion Echocardiography
Number of Subjects With a Perfusion Defect
A perfusion defect will first be identified using clinically indicated invasive coronary angiography (ICA). The presence of a perfusion defect will then be identified using non-invasive real time myocardial perfusion echocardiography (RTMPE).
Time frame: baseline
| Milestone | RTMPE |
|---|---|
| Started | 36 |
| Completed | 36 |
| Not completed | 0 |
A perfusion defect will first be identified using clinically indicated invasive coronary angiography (ICA). The presence of a perfusion defect will then be identified using non-invasive real time myocardial perfusion echocardiography (RTMPE).
| Participants | RTMPE |
|---|---|
| Perfusion defect identified by ICA | 5 |
| Perfusion defect identified by RTMPE | 6 |
Collected over Adverse event data were collected during the duration of the echocardiogram, approximately 40 minutes.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RTMPE | 0/36 (0%) | 0/36 (0%) | 0/36 (0%) |
| Age, Continuous(years) | RTMPE |
|---|---|
| Mean | 14 ± 5 |
| Sex: Female, Male(Participants) | RTMPE |
|---|---|
| Female | 15 |
| Male | 21 |
| Race and Ethnicity Not Collected(Participants) | RTMPE |
|---|
| Region of Enrollment(participants) | RTMPE |
|---|---|
| United States | 27 |
| Canada | 9 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Dr. Nowell Fine University of Calgary 1403 29th Street NW Canada Researchers at University of Calgary are also conducting this study and will collaborate with Mayo Clinic on the research data. Study identification number, subject Identification, or any other unique identifying number, characteristic, or code that the external party is unable to link to the identity of the subject. Dates: all elements of dates \[month, day, and year\] directly related to an individual, e.g. date of birth, death, or diagnosis, etc. City, county, precinct, zip code, and their equivalent geocodes.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mayo Clinic