Real Time Myocardial Perfusion Echocardiography for Coronary Allograft Vasculopathy

NCT02880137 | Completed Phase 4 Results DMC

• 1 other identifier: 15-007825
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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?

Conditions

Cardiac Allograft Vasculopathy

Outcome Measures

Primary Outcomes (1)

• 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).

  baseline

Study Arms (1)

RTMPE

EXPERIMENTAL

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

Interventions

Perflutren Lipid Microsphere DRUG

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

RTMPE

RTMPE PROCEDURE

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

RTMPE

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• University of Calgary: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

perflutren

Results Point of Contact

• Title: Dr. Jonathan Johnson
• Organization: Mayo Clinic

johnson.jonathan@mayo.edu

507-255-7013

Study Officials

• Jonathan N Johnson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: August 26, 2016
• Study Start: September 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 30, 2018
• Last Updated: June 20, 2019
• Results First Posted: June 20, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)