ID
36487
Beschreibung
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.
Link
https://clinicaltrials.gov/show/NCT02197065
Stichworte
Versionen (1)
- 17.05.19 17.05.19 -
Rechteinhaber
Hospital for Special Surgery, New York
Hochgeladen am
17. Mai 2019
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Atorvastatin as Post-OP NCT02197065
Eligibility Criteria
- StudyEvent: Eligibility
Beschreibung
Exclusion Criteria
Alias
- UMLS CUI
- C0680251
Beschreibung
Pathological Hip fracture (cancer)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0019557
- UMLS CUI [1,2]
- C0016663
- UMLS CUI [1,3]
- C0678226
- UMLS CUI [1,4]
- C0006826
Beschreibung
Recent Statin Use
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1524063
- UMLS CUI [1,2]
- C0360714
- UMLS CUI [1,3]
- C0332185
Beschreibung
Statin intolerance
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1744706
- UMLS CUI [1,2]
- C0360714
Beschreibung
Myocardial infarction or unstable angina
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0155626
- UMLS CUI [2]
- C0002965
Beschreibung
Cardial Handicap
Datentyp
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
Beschreibung
Hip fracture with peripheral artery disease
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0019557
- UMLS CUI [1,2]
- C1704436
Beschreibung
Hip fracture with cerebral insult
Datentyp
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
Beschreibung
Muscle Disorder
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0026845
- UMLS CUI [1,2]
- C0012634
Beschreibung
Liver Disease
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C0205404
- UMLS CUI [2,1]
- C0151905
- UMLS CUI [2,2]
- C0205250
Beschreibung
Renal disease
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0022658
- UMLS CUI [1,2]
- C0205404
- UMLS CUI [2]
- C0151577
Beschreibung
HIV Protease Inhibitor or Hepatitis C Protease Inhibitor
Datentyp
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
Beschreibung
Antimicrobial therapy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0014806
- UMLS CUI [2]
- C0055856
- UMLS CUI [3]
- C0027996
- UMLS CUI [4]
- C0360363
Beschreibung
Pregant or Breastfeeding
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
- UMLS CUI [3]
- C0032992
Ähnliche Modelle
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])