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出境医 / 临床实验 / Vascular Cardiotoxicity of Ponatinib
Vascular Cardiotoxicity of Ponatinib
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 | 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.
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 15, 2019 |
| Estimated Primary Completion Date : | May 1, 2021 |
| Estimated Study Completion Date : | May 1, 2022 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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.
- 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.
- Carotid plaque size [ Time Frame: 6 months ]Changes in IMT or plaque size
- Carotid plaque size [ Time Frame: 12 months ]Changes in IMT or plaque size
Eligibility Criteria
Contacts and Locations
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | April 24, 2019 | ||||||
| First Posted Date | April 29, 2019 | ||||||
| Last Update Posted Date | June 7, 2019 | ||||||
| Actual Study Start Date | May 15, 2019 | ||||||
| Estimated Primary Completion Date | May 1, 2021 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures | Not Provided | ||||||
| Original Secondary Outcome Measures | Not Provided | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | Vascular Cardiotoxicity of Ponatinib | ||||||
| Official Title | Vascular Cardiotoxicity of Ponatinib | ||||||
| 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 Type | Observational | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Probability Sample | ||||||
| Study Population | Subjects diagnosed with CML or ALL who are to be treated with ponatinib. | ||||||
| Condition | Cardiotoxicity | ||||||
| Intervention | 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
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| Study Groups/Cohorts | Not Provided | ||||||
| Publications * | 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, López 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. | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Recruiting | ||||||
| Estimated Enrollment |
32 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | May 1, 2022 | ||||||
| Estimated Primary Completion Date | May 1, 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 100 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | Not Provided | ||||||
| Contacts |
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| Listed Location Countries | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03930394 | ||||||
| Other Study ID Numbers | Ponatinib Cardiotoxicity | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Jonathan R. Lindner, MD, Oregon Health and Science University | ||||||
| Study Sponsor | Oregon Health and Science University | ||||||
| Collaborators | Not Provided | ||||||
| Investigators | Not Provided | ||||||
| PRS Account | Oregon Health and Science University | ||||||
| Verification Date | June 2019 | ||||||
