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| Name | Class |
|---|---|
| VA Greater Los Angeles Healthcare System | FED |
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This study aims to evaluate the effects of cardiotoxic cancer therapies on myocardial blood flow (MBF) and perfusion in a prospective sample of VA patients.
Up to 60 patients who will be newly initiating chemotherapy are going to be prospectively evaluated using PET myocardial perfusion imaging (MPI) for chemotherapy-induced cardiotoxicity by quantifying MBF and perfusion. Patients will be grouped into 3 categories:
Patients will undergo PET MPI at 3 different time points:
For PET MPI, the investigators will evaluate for abnormalities such as new perfusion defects, decreases in stress myocardial blood flows and decreases in myocardial flow reserves.
All study patients will also be analyzed using the following tests:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anthracycline | Patients undergoing chemotherapy with an anthracycline-containing regimen. | ||
| VEGF Inhibitor | Patients undergoing chemotherapy with a vascular endothelial growth factor (VEGF) inhibitor-containing regimen. | ||
| Immune Checkpoint Inhibitor | Patients undergoing chemotherapy with an immune check point inhibitor-containing regimen. |
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| Measure | Description | Time Frame |
|---|---|---|
| PET myocardial perfusion imaging (MPI). | Change from baseline in number of patients with perfusion defects measured as % total perfusion deficit (TPD) of the left ventricular myocardium by PET | Baseline (within 1 month prior to the initiation of cancer treatment), during cancer treatment (estimated at 1-6 months), and within 1 month post-cancer treatment completion (approximately 2-9 months) |
| PET myocardial blood flow (MBF) measurement. | Change from baseline in number of patients with myocardial blood flow abnormalities measured as stress myocardial blood flow (SMBF) values < 2 mL/min/g of left ventricular myocardium by PET | Baseline (within 1 month prior to the initiation of cancer treatment), during cancer treatment (estimated at 1-6 months), and within 1 month post-cancer treatment completion (approximately 2-9 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Transthoracic echocardiography (TTE) global left ventricular systolic function. | Change from baseline in number of patients with global systolic dysfunction measured as % left ventricular ejection fraction by TTE. | Baseline (within 1 month prior to the initiation of cancer treatment), during cancer treatment (estimated at 1-6 months), and within 1 month post-cancer treatment completion (approximately 2-9 months) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with cancer receiving medical care at the West Los Angeles Veterans Affairs Medical Center / Greater Los Angeles Veterans Affairs Healthcare System.
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| Name | Affiliation | Role |
|---|---|---|
| Rene Packard, MD, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Los Angeles VA Medical Center | Los Angeles | California | 90073 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33433946 | Background | Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12. | |
| 27022039 | Background | Herrmann J, Yang EH, Iliescu CA, Cilingiroglu M, Charitakis K, Hakeem A, Toutouzas K, Leesar MA, Grines CL, Marmagkiolis K. Vascular Toxicities of Cancer Therapies: The Old and the New--An Evolving Avenue. Circulation. 2016 Mar 29;133(13):1272-89. doi: 10.1161/CIRCULATIONAHA.115.018347. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D003324 | Coronary Artery Disease |
| D017566 | Microvascular Angina |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Transthoracic echocardiography (TTE) focal left ventricular systolic function. | Change from baseline in number of patients with focal systolic dysfunction measured as % left ventricular global longitudinal strain by TTE. | Baseline (within 1 month prior to the initiation of cancer treatment), during cancer treatment (estimated at 1-6 months), and within 1 month post-cancer treatment completion (approximately 2-9 months) |
| Transthoracic echocardiography (TTE) focal left atrial systolic function. | Change from baseline in number of patients with focal systolic dysfunction measured as % left atrial strain by TTE. | Baseline (within 1 month prior to the initiation of cancer treatment), during cancer treatment (estimated at 1-6 months), and within 1 month post-cancer treatment completion (approximately 2-9 months) |
| Electrocardiogram (ECG) findings. | Change from baseline in number of patients with any of the following ECG changes:
| Baseline (within 1 month prior to the initiation of cancer treatment), during cancer treatment (estimated at 1-6 months), and within 1 month post-cancer treatment completion (approximately 2-9 months) |
| Metabolic or cardiac function abnormalities as determined by blood work findings | Change from baseline in number of patients with changes in the values of serological tests indicative of metabolic or cardiac function abnormalities including one or more of the following:
| Baseline (within 1 month prior to the initiation of cancer treatment), during cancer treatment (estimated at 1-6 months), and within 1 month post-cancer treatment completion (approximately 2-9 months) |
| 29145954 | Background | Chang HM, Moudgil R, Scarabelli T, Okwuosa TM, Yeh ETH. Cardiovascular Complications of Cancer Therapy: Best Practices in Diagnosis, Prevention, and Management: Part 1. J Am Coll Cardiol. 2017 Nov 14;70(20):2536-2551. doi: 10.1016/j.jacc.2017.09.1096. |
| 31397169 | Background | Hader SN, Zinkevich N, Norwood Toro LE, Kriegel AJ, Kong A, Freed JK, Gutterman DD, Beyer AM. Detrimental effects of chemotherapy on human coronary microvascular function. Am J Physiol Heart Circ Physiol. 2019 Oct 1;317(4):H705-H710. doi: 10.1152/ajpheart.00370.2019. Epub 2019 Aug 9. |
| 19520246 | Background | Yeh ET, Bickford CL. Cardiovascular complications of cancer therapy: incidence, pathogenesis, diagnosis, and management. J Am Coll Cardiol. 2009 Jun 16;53(24):2231-47. doi: 10.1016/j.jacc.2009.02.050. |
| 29242396 | Background | Murthy VL, Bateman TM, Beanlands RS, Berman DS, Borges-Neto S, Chareonthaitawee P, Cerqueira MD, deKemp RA, DePuey EG, Dilsizian V, Dorbala S, Ficaro EP, Garcia EV, Gewirtz H, Heller GV, Lewin HC, Malhotra S, Mann A, Ruddy TD, Schindler TH, Schwartz RG, Slomka PJ, Soman P, Di Carli MF; SNMMI Cardiovascular Council Board of Directors; ASNC Board of Directors. Clinical Quantification of Myocardial Blood Flow Using PET: Joint Position Paper of the SNMMI Cardiovascular Council and the ASNC. J Nucl Med. 2018 Feb;59(2):273-293. doi: 10.2967/jnumed.117.201368. Epub 2017 Dec 14. No abstract available. |
| 22007073 | Background | Murthy VL, Naya M, Foster CR, Hainer J, Gaber M, Di Carli G, Blankstein R, Dorbala S, Sitek A, Pencina MJ, Di Carli MF. Improved cardiac risk assessment with noninvasive measures of coronary flow reserve. Circulation. 2011 Nov 15;124(20):2215-24. doi: 10.1161/CIRCULATIONAHA.111.050427. Epub 2011 Oct 17. |
| 21816311 | Background | Ziadi MC, Dekemp RA, Williams KA, Guo A, Chow BJ, Renaud JM, Ruddy TD, Sarveswaran N, Tee RE, Beanlands RS. Impaired myocardial flow reserve on rubidium-82 positron emission tomography imaging predicts adverse outcomes in patients assessed for myocardial ischemia. J Am Coll Cardiol. 2011 Aug 9;58(7):740-8. doi: 10.1016/j.jacc.2011.01.065. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000787 | Angina Pectoris |