Vascular Cardiotoxicity of Ponatinib

• Conditions: Cardiotoxicity

• Registration Number: NCT03930394
• Lead Sponsor: Oregon Health and Science University

Brief Summary

Pre-clinical studies suggest that the third generation tyrosine kinase inhibitor ponatinib can result in microvascular angiopathy and acceleration of atherosclerosis. This study is intended to examine for myocardial microvascular angiopathy and changes in carotid plaque in patients receiving ponatinib as part of their clinical care.

Detailed Description

In this study, we will perform serial echocardiography for ventricular function, myocardial contrast echocardiography for microvascular perfusion assessment, blood analysis for myocardial injury, and carotid US for plaque or IMT progression in subjects receiving ponatinib. This series of tests is intended to provide information on the presence of clinically-evident or subclinical microvascular angiopathy and plaque acceleration.

Study Timeline

• Study First Submitted: 2019-04-24
• Study First Submitted QC: 2019-04-26
• Study First Posted: 2019-04-29
• Study Start: 2019-05-15
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-05
• Last Update Posted: 2019-06-07
• Primary Completion: 2021-05-01
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Diagnosis of CML or ALL
• Prescribed ponatinib

Exclusion Criteria

• pregnancy or lactation
• major medical illness involving the heart or vasculature (CAD, PAD, DCM).
• hemodynamically unstable
• allergy to ultrasound contrast agents.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Carotid plaque size	12 months	Changes in IMT or plaque size
Presence versus absence of any myocardial perfusion defect assessed by visual analysis for any abnormalities of microvascular flux rate (beta function) or microvascular blood volume during an infusion of ultrasound microbubble contrast agents.	12 months	Contrast ultrasound perfusion imaging will be performed using power-modulation imaging and infusion of an ultrasound contrast agent. Destruction replenishment kinetics will be assessed visually by examination of delayed replenishment of signal intensity (\>5 seconds) after a high-mechanical index burst sequence, or abnormalities in plateau intensity reflecting regional abnormalities in myocardial microvascular blood volume.

Trial Locations

Locations (1)

Oregon HSU; 🇺🇸 Portland, Oregon, United States