NCT03930394

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
16 days until next milestone

Study Start

First participant enrolled

May 15, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

June 7, 2019

Status Verified

June 1, 2019

Enrollment Period

2 years

First QC Date

April 24, 2019

Last Update Submit

June 5, 2019

Conditions

Cardiotoxicity

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    12 months

  • Carotid plaque size

    Changes in IMT or plaque size

    6 months

  • Carotid plaque size

    Changes in IMT or plaque size

    12 months

Interventions

Contrast ultrasound perfusion imagingDIAGNOSTIC_TEST

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.

Also known as: Carotid ultrasound

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects diagnosed with CML or ALL who are to be treated with ponatinib.

You may qualify if:

  • Diagnosis of CML or ALL
  • Prescribed ponatinib

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon HSU

Portland, Oregon, 97221, United States

RECRUITING

Related Publications (1)

  • Latifi Y, Moccetti F, Wu M, Xie A, Packwood W, Qi Y, Ozawa K, Shentu W, Brown E, Shirai T, McCarty OJ, Ruggeri Z, Moslehi J, Chen J, Druker BJ, Lopez JA, Lindner JR. Thrombotic microangiopathy as a cause of cardiovascular toxicity from the BCR-ABL1 tyrosine kinase inhibitor ponatinib. Blood. 2019 Apr 4;133(14):1597-1606. doi: 10.1182/blood-2018-10-881557. Epub 2019 Jan 28.

    PMID: 30692122BACKGROUND

MeSH Terms

Conditions

Cardiotoxicity

Interventions

Ultrasonography, Carotid Arteries

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Melinda Wu, MD

CONTACT

503 494-4772wume@ohsu.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 24, 2019

First Posted

April 29, 2019

Study Start

May 15, 2019

Primary Completion

May 1, 2021

Study Completion

May 1, 2022

Last Updated

June 7, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)