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Vascular Cardiotoxicity of Ponatinib

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03930394
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Jonathan R. Lindner, MD, 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.

Condition or disease Intervention/treatment
Cardiotoxicity Diagnostic Test: Contrast ultrasound perfusion imaging

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.

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Study Type : Observational
Estimated Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vascular Cardiotoxicity of Ponatinib
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
Drug Information available for: Ponatinib


Intervention Details:
  • Diagnostic Test: 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.
    Other Name: Carotid ultrasound


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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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): NCT03930394


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

Locations
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United States, Oregon
Oregon HSU Recruiting
Portland, Oregon, United States, 97221
Contact: Melinda Wu, MD    503-494-9000    wume@ohsu.edu   
Contact: Jonathan Lindner, MD    503494900    lindnerj@ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University
Publications:
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Responsible Party: Jonathan R. Lindner, MD, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03930394    
Other Study ID Numbers: Ponatinib Cardiotoxicity
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries