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Real Time Myocardial Perfusion Echocardiography for Coronary Allograft Vasculopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02880137
Recruitment Status : Completed
First Posted : August 26, 2016
Results First Posted : June 20, 2019
Last Update Posted : June 20, 2019
Sponsor:
Collaborator:
University of Calgary
Information provided by (Responsible Party):
Jonathan N. Johnson, M.D., Mayo Clinic

Brief Summary:
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?

Condition or disease Intervention/treatment Phase
Cardiac Allograft Vasculopathy Drug: Perflutren Lipid Microsphere Procedure: RTMPE Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: (RTMPE for CAV) Real Time Myocardial Perfusion Echocardiography for Detection of Coronary Allograft Vasculopathy in Cardiac Transplant Patients
Actual Study Start Date : September 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Perflutren

Arm Intervention/treatment
Experimental: RTMPE
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
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.
Other Name: Definity

Procedure: RTMPE
Utilizes intravenous administration of biologically-inert microbubbles to assess myocardial perfusion and has demonstrated utility for identifying small vessel coronary artery disease.
Other Name: Real Time Myocardial Perfusion Echocardiography




Primary Outcome Measures :
  1. Number of Subjects With a Perfusion Defect [ Time Frame: baseline ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Cardiac transplant recipients (> or equal to 10 months post transplant)
  • Clinically followed at Mayo Clinic, Rochester Minnesota

Exclusion:

  • Standard contraindications to the use of ultrasound contrast and pharmacologic stress
  • Recent (< 3 months) hospitalization for heart failure, acute coronary syndrome or allograft rejection
  • Multi-organ transplant Known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts
  • Hypersensitivity to perflutren

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880137


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
University of Calgary
Investigators
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Principal Investigator: Jonathan N Johnson, MD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Jonathan N. Johnson, M.D., Mayo Clinic:

Additional Information:
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Responsible Party: Jonathan N. Johnson, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02880137    
Other Study ID Numbers: 15-007825
First Posted: August 26, 2016    Key Record Dates
Results First Posted: June 20, 2019
Last Update Posted: June 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases