ID
36487
Beskrivning
Pilot Study of Atorvastatin for Orthopedic Surgery Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02197065 Brief Summary: Up to 35% of hip fracture patients have been shown to experience heart injury after surgery, and as many as 10% have a heart attack or die in the three months after surgery. Hip and knee arthroplasty patients are also at risk of cardiovascular complications. Patients who have these complications have higher levels of inflammation postoperatively. Statins (such as atorvastatin/Lipitor) lower cholesterol and also lessen inflammation. Both of these effects are important in preventing heart attacks. Statins have been shown to reduce the risk of heart attacks in non-surgical patients, and to protect from heart attacks in patients having heart surgery. Whether statins can prevent heart attacks in orthopedic patients is not known. In this pilot study the investigators will treat 30 orthopedic surgery patients (hip fracture, hip or knee arthroplasty) with either atorvastatin or placebo (a capsule with no study drug). Patients will start the study drug prior to surgery and take it for 45 days after surgery. Neither the doctors nor the patients will know whether they are taking atorvastatin or placebo. The investigators will look for evidence of inflammation and heart injury after surgery. The investigators hypothesize that atorvastatin will lessen the degree of postoperative inflammation found in these patients. In this study, the investigators will use a very sensitive test of heart injury that can detect problems even when patients have no symptoms. The investigators hypothesize that this test will demonstrate silent heart injury in over 50% of the hip fracture patients and over 30% of arthroplasty patients in our study. The results of this trial will help us to develop a larger study in 1000 hip fracture and joint replacement patients to determine whether atorvastatin protects orthopedic surgery patients from heart injury and other complications of surgery.
Länk
https://clinicaltrials.gov/show/NCT02197065
Nyckelord
Versioner (1)
- 17/05/2019 17/05/2019 -
Rättsinnehavare
Hospital for Special Surgery, New York
Uppladdad den
17 de maio de 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Atorvastatin as Post-OP NCT02197065
Eligibility Criteria
- StudyEvent: Eligibility
Beskrivning
Exclusion Criteria
Alias
- UMLS CUI
- C0680251
Beskrivning
Pathological Hip fracture (cancer)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0019557
- UMLS CUI [1,2]
- C0016663
- UMLS CUI [1,3]
- C0678226
- UMLS CUI [1,4]
- C0006826
Beskrivning
Recent Statin Use
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1524063
- UMLS CUI [1,2]
- C0360714
- UMLS CUI [1,3]
- C0332185
Beskrivning
Statin intolerance
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1744706
- UMLS CUI [1,2]
- C0360714
Beskrivning
Myocardial infarction or unstable angina
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0155626
- UMLS CUI [2]
- C0002965
Beskrivning
Cardial Handicap
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0027051
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0948089
- UMLS CUI [3,1]
- C0262926
- UMLS CUI [3,2]
- C0002962
- UMLS CUI [4,1]
- C0262926
- UMLS CUI [4,2]
- C0027056
Beskrivning
Hip fracture with peripheral artery disease
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0019557
- UMLS CUI [1,2]
- C1704436
Beskrivning
Hip fracture with cerebral insult
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0019557
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C0007787
- UMLS CUI [2,1]
- C0019557
- UMLS CUI [2,2]
- C0262926
- UMLS CUI [2,3]
- C0038454
Beskrivning
Muscle Disorder
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0026845
- UMLS CUI [1,2]
- C0012634
Beskrivning
Liver Disease
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C0205404
- UMLS CUI [2,1]
- C0151905
- UMLS CUI [2,2]
- C0205250
Beskrivning
Renal disease
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0022658
- UMLS CUI [1,2]
- C0205404
- UMLS CUI [2]
- C0151577
Beskrivning
HIV Protease Inhibitor or Hepatitis C Protease Inhibitor
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0162714
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C0019196
- UMLS CUI [2,3]
- C0033607
Beskrivning
Antimicrobial therapy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0014806
- UMLS CUI [2]
- C0055856
- UMLS CUI [3]
- C0027996
- UMLS CUI [4]
- C0360363
Beskrivning
Pregant or Breastfeeding
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
- UMLS CUI [3]
- C0032992
Similar models
Eligibility Criteria
- StudyEvent: Eligibility
C0392806 (UMLS CUI [2])
C0086511 (UMLS CUI [3])
C0016663 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,4])
C0360714 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0360714 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0948089 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0002962 (UMLS CUI [3,2])
C0262926 (UMLS CUI [4,1])
C0027056 (UMLS CUI [4,2])
C1704436 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
C0007787 (UMLS CUI [1,3])
C0019557 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0038454 (UMLS CUI [2,3])
C0012634 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,2])
C0151905 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
C0205404 (UMLS CUI [1,2])
C0151577 (UMLS CUI [2])
C0162714 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C0033607 (UMLS CUI [2,3])
C0055856 (UMLS CUI [2])
C0027996 (UMLS CUI [3])
C0360363 (UMLS CUI [4])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])