ID

36487

Description

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

Keywords

Versions (1)
  1. 5/17/19 5/17/19 -
Copyright Holder

Hospital for Special Surgery, New York

Uploaded on

May 17, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Atorvastatin as Post-OP NCT02197065

English

Eligibility Criteria

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Does the participant have hip fracture or elective hip or knee arthroplasty?
Description

Orthopedic Procedure or Problem

Data type

boolean

Alias
UMLS CUI [1]
C0019557
UMLS CUI [2]
C0392806
UMLS CUI [3]
C0086511
Is the partipant age 65 or older?
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Does the participant have a life expectancy of over 3 months?
Description

Life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Does the participant have a pathological hip fracture due to cancer?
Description

Pathological Hip fracture (cancer)

Data type

boolean

Alias
UMLS CUI [1,1]
C0019557
UMLS CUI [1,2]
C0016663
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0006826
Does the participant currently take a statin, or took a statin within the last 30 days?
Description

Recent Statin Use

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0360714
UMLS CUI [1,3]
C0332185
Does the participant have previous statin intolerance?
Description

Statin intolerance

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0360714
Does the participant have acute myocardial infarction or unstable angina?
Description

Myocardial infarction or unstable angina

Data type

boolean

Alias
UMLS CUI [1]
C0155626
UMLS CUI [2]
C0002965
Does the participant have history of myocardial infarction, acute coronary syndrome, angina, coronary/arterial re-vascularization?
Description

Cardial Handicap

Data type

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
Does the participant have hip fracture with peripheral arterial disease?
Description

Hip fracture with peripheral artery disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0019557
UMLS CUI [1,2]
C1704436
Does the participant have a hip fracture with history of stroke or transient ischemic attack?
Description

Hip fracture with cerebral insult

Data type

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
Does the participant have a muscle disorder?
Description

Muscle Disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0026845
UMLS CUI [1,2]
C0012634
Does the participant have a serious liver disease or alanine aminotransferase > 3x upper limit of normal?
Description

Liver Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0151905
UMLS CUI [2,2]
C0205250
Does the participant have a serious renal disease (creatinine clearance <30cc/min)?
Description

Renal disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0151577
Does the participant have treatment with hiv protease inhibitor or hepatitis c protease inhibitor?
Description

HIV Protease Inhibitor or Hepatitis C Protease Inhibitor

Data type

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
Does the participant have treatment with erythromycin, clarithromycin, niacin or azole antifungal agent?
Description

Antimicrobial therapy

Data type

boolean

Alias
UMLS CUI [1]
C0014806
UMLS CUI [2]
C0055856
UMLS CUI [3]
C0027996
UMLS CUI [4]
C0360363
pregnant, planning to become pregnant, or breastfeeding
Description

Pregant or Breastfeeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Orthopedic Procedure or Problem
Item
Does the participant have hip fracture or elective hip or knee arthroplasty?
boolean
C0019557 (UMLS CUI [1])
C0392806 (UMLS CUI [2])
C0086511 (UMLS CUI [3])
Age
Item
Is the partipant age 65 or older?
boolean
C0001779 (UMLS CUI [1])
Life expectancy
Item
Does the participant have a life expectancy of over 3 months?
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pathological Hip fracture (cancer)
Item
Does the participant have a pathological hip fracture due to cancer?
boolean
C0019557 (UMLS CUI [1,1])
C0016663 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,4])
Recent Statin Use
Item
Does the participant currently take a statin, or took a statin within the last 30 days?
boolean
C1524063 (UMLS CUI [1,1])
C0360714 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Statin intolerance
Item
Does the participant have previous statin intolerance?
boolean
C1744706 (UMLS CUI [1,1])
C0360714 (UMLS CUI [1,2])
Myocardial infarction or unstable angina
Item
Does the participant have acute myocardial infarction or unstable angina?
boolean
C0155626 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
Cardial Handicap
Item
Does the participant have history of myocardial infarction, acute coronary syndrome, angina, coronary/arterial re-vascularization?
boolean
C0262926 (UMLS CUI [1,1])
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])
Hip fracture with peripheral artery disease
Item
Does the participant have hip fracture with peripheral arterial disease?
boolean
C0019557 (UMLS CUI [1,1])
C1704436 (UMLS CUI [1,2])
Hip fracture with cerebral insult
Item
Does the participant have a hip fracture with history of stroke or transient ischemic attack?
boolean
C0019557 (UMLS CUI [1,1])
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])
Muscle Disorder
Item
Does the participant have a muscle disorder?
boolean
C0026845 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Liver Disease
Item
Does the participant have a serious liver disease or alanine aminotransferase > 3x upper limit of normal?
boolean
C0201899 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0151905 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
Renal disease
Item
Does the participant have a serious renal disease (creatinine clearance <30cc/min)?
boolean
C0022658 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0151577 (UMLS CUI [2])
HIV Protease Inhibitor or Hepatitis C Protease Inhibitor
Item
Does the participant have treatment with hiv protease inhibitor or hepatitis c protease inhibitor?
boolean
C0087111 (UMLS CUI [1,1])
C0162714 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C0033607 (UMLS CUI [2,3])
Antimicrobial therapy
Item
Does the participant have treatment with erythromycin, clarithromycin, niacin or azole antifungal agent?
boolean
C0014806 (UMLS CUI [1])
C0055856 (UMLS CUI [2])
C0027996 (UMLS CUI [3])
C0360363 (UMLS CUI [4])
Pregant or Breastfeeding
Item
pregnant, planning to become pregnant, or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
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