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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

Vascular Cardiotoxicity of Ponatinib

Clinicaltrials.gov identifier NCT03930394

Recruitment Status Recruiting

First Posted April 29, 2019

Last update posted June 7, 2019

Study Description

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.

  • Condition or Disease:Cardiotoxicity
  • Intervention/Treatment: Diagnostic Test: Contrast ultrasound perfusion imaging
  • Phase: N/A
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 Design
  • Study Type: Observational
  • Estimated Enrollment: 32 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Vascular Cardiotoxicity of Ponatinib
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: May 2021
  • Estimated Study Completion Date: May 2022
Outcome Measures
  • Primary Outcome Measures: 1. 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 ]
    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.
  • 2. 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 ]
    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.
  • 3. Carotid plaque size [ Time Frame: 6 months ]
    Changes in IMT or plaque size
  • 4. Carotid plaque size [ Time Frame: 12 months ]
    Changes in IMT or plaque size
Eligibility Criteria
  • Ages Eligible for Study: 18 to 100 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers:
  • Sampling Method: Probability Sample
  • Study Population: Subjects diagnosed with CML or ALL who are to be treated with ponatinib.
Criteria

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.

Contacts and Locations
Contacts

Contact: Melinda Wu, MD 503 494-4772 wume@ohsu.edu

Locations

United States, Oregon
Oregon HSU
Portland

Sponsors and Collaborators

Oregon Health and Science University

More Information