Recruiting

Ponatinib

Sponsor:

Oregon Health and Science University

Code:

NCT03930394

Conditions

Cardiotoxicity

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Contrast ultrasound perfusion imaging

Study Details

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.

Conditions

Cardiotoxicity

Study ID

NCT03930394

Start date

May 15, 2019

Status verified date

Jun, 2019

Completion date

May 1, 2022

Anticipated

Primary completion date

May 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

32 participants

Anticipated

Interventions and Outcome Measures

Interventions

Contrast ultrasound perfusion imaging

Contrast ultrasound perfusion imaging for microvascular perfusion, and carotid ultrasound data on intima-media thickness (or plaque size) will be serially assessed in subjects started on ponatinib.

Primary outcome measure

  • 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. [ Time Frame: 6 months ]
  • 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. [ Time Frame: 12 months ]
  • Carotid plaque size [ Time Frame: 6 months ]
  • Carotid plaque size [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Melinda Wu, MD

503 494-4772wume@ohsu.edu

Locations

Oregon HSU

Recruiting

Portland, Oregon, United States, 97221

Contacts

Melinda Wu, MD

503-494-9000wume@ohsu.edu

Jonathan Lindner, MD

503494900lindnerj@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Jun 7, 2019

Last verified

Jun, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2019-06-07.