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ID
38199
Beschreibung
Carvedilol for the Prevention of Anthracycline/Anti-HER2 Therapy Associated Cardiotoxicity Among Women With HER2-Positive Breast Cancer Using Myocardial Strain Imaging for Early Risk Stratification; ODM derived from: https://clinicaltrials.gov/show/NCT02177175
Link
https://clinicaltrials.gov/show/NCT02177175
Stichworte
Versionen (2)
- 26.09.19 26.09.19 -
- 26.09.19 26.09.19 -
Rechteinhaber
See clinicaltrials.gov
Hochgeladen am
26. September 2019
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Eligibility Breast Cancer NCT02177175
Eligibility Breast Cancer NCT02177175
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Breast Cancer NCT02177175
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Invasive carcinoma of breast | Neoplasm Metastasis Absent
Item
non-metastatic histologically confirmed primary invasive breast carcinoma
boolean
C0853879 (UMLS CUI [1])
C0027627 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
HER2-positive carcinoma of breast
Item
pathologically confirmed her2-positive breast cancer
boolean
C1960398 (UMLS CUI [1])
Chemotherapy Scheduled | Anthracyclines | HER2 Targeted Therapy
Item
scheduled to receive anthracycline chemotherapy followed by anti-her2 therapy at mskcc
boolean
C0392920 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0282564 (UMLS CUI [2])
C0069515 (UMLS CUI [3,1])
C2985566 (UMLS CUI [3,2])
C0205539 (UMLS CUI [1,2])
C0282564 (UMLS CUI [2])
C0069515 (UMLS CUI [3,1])
C2985566 (UMLS CUI [3,2])
Informed Consent
Item
able and willing to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
willing and able to comply with the requirements of the protocol
boolean
C0525058 (UMLS CUI [1])
Able to swallow capsules
Item
able to swallow capsules
boolean
C2712086 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,2])
Criteria Fulfill
Item
for aim 2, all patients must meet the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,2])
Inclusion criteria Fulfill
Item
meet all inclusion criteria above
boolean
C1512693 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
lvef > 50%
boolean
C0428772 (UMLS CUI [1])
Longitudinal strain rate.diastole.max Abnormal | Longitudinal strain rate.systole.max Abnormal | Status pre-HER2 Targeted Therapy
Item
abnormal global longitudinal strain (<19%, or a % decrease of ≥ 11% from baseline) prior to initiation of planned anti-her2 therapy
boolean
C4263402 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C4263410 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C0332152 (UMLS CUI [3,1])
C0069515 (UMLS CUI [3,2])
C2985566 (UMLS CUI [3,3])
C0205161 (UMLS CUI [1,2])
C4263410 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C0332152 (UMLS CUI [3,1])
C0069515 (UMLS CUI [3,2])
C2985566 (UMLS CUI [3,3])
Heart rate
Item
heart rate ≥ 50 beats per minute
boolean
C0018810 (UMLS CUI [1])
Sitting systolic blood pressure
Item
sitting systolic blood pressure > 90 mmhg
boolean
C1319893 (UMLS CUI [1])
Criteria Fulfill
Item
patients are to be excluded from randomization for aim 2 of this study if they meet any of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,2])
Angiotensin-Converting Enzyme Inhibitors | Adrenergic beta-1 Receptor Antagonists
Item
current treatment with ace-inhibitors or beta blockers
boolean
C0003015 (UMLS CUI [1])
C0304516 (UMLS CUI [2])
C0304516 (UMLS CUI [2])
ID.17
Item
allergies or inability to tolerate beta blockers previously due to bradycardia, hypotension, or av block.
boolean
ID.18
Item
known history of nci ctcae (version 4.0) grade ≥ 2 symptomatic chf, myocardial infarction within 12 months prior to randomization, significant symptoms (grade ≥ 3) relating to left ventricular dysfunction, significant (moderate or severe) valvular disease, or significant cardiac arrhythmia (grade ≥ 3)
boolean
ID.19
Item
pre-menopausal women without a negative serum or urine pregnancy test within 4 weeks of starting treatment
boolean
ID.20
Item
already enrolled in a breast cancer medicine therapeutic intervention trial
boolean