ID

27618

Beskrivning

Role of Vitamin D in Secondary Prevention of Cardiovascular Events; ODM derived from: https://clinicaltrials.gov/show/NCT01018849

Länk

https://clinicaltrials.gov/show/NCT01018849

Nyckelord

Versioner (1)
  1. 2017-11-22 2017-11-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 november 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT01018849

Engelsk

Eligibility Cardiovascular Disease NCT01018849

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female of age > 19 years at the time informed consent is signed.
Beskrivning

Age | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
subject with a diagnosis of unstable angina (with thrombolysis in myocardial infarction (timi) score of greater than or equal to 3) / nstemi or stemi,or documented coronary artery disease defined as at least one coronary artery with > 50% occlusion
Beskrivning

Angina, Unstable | TIMI Flow NSTEMI | TIMI Flow STEMI | Coronary Artery Disease | Coronary Occlusion Percentage Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2,1]
C3272266
UMLS CUI [2,2]
C3537184
UMLS CUI [3,1]
C3272266
UMLS CUI [3,2]
C1536220
UMLS CUI [4]
C1956346
UMLS CUI [5,1]
C0151814
UMLS CUI [5,2]
C0439165
UMLS CUI [5,3]
C1265611
subject who is able to come back to our clinic for follow up visits for at least 1 year after enrollment.
Beskrivning

Patient Available Follow-up visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0589121
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject is on treatment with either phenytoin or phenobarbitol or orlistat (since these medications may cause vitamin d deficiency).
Beskrivning

Phenytoin | Phenobarbital | orlistat

Datatyp

boolean

Alias
UMLS CUI [1]
C0031507
UMLS CUI [2]
C0031412
UMLS CUI [3]
C0076275
subject who needs two or more steroid bursts per year for other co-morbid conditions (since steroids may impair vitamin d metabolism).
Beskrivning

Comorbidity | Steroids Quantity per year Patient need for

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0439508
UMLS CUI [2,4]
C0686904
subject is on an investigational drug, which is a new drug class and not part of standard acs protocol.
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
subject is taking supplements of vitamin d with doses >400 iu/day.
Beskrivning

Vitamin D supplement Dose IU/day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3541352
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439465
subject has hypersensitivity to vitamin d products.
Beskrivning

Vitamin D allergy

Datatyp

boolean

Alias
UMLS CUI [1]
C0571828
subject has history of systemic lupus erythematosus (since vitamin d deficiency is common in this group27).
Beskrivning

Lupus Erythematosus, Systemic

Datatyp

boolean

Alias
UMLS CUI [1]
C0024141
subject has history of sarcoidosis (since they have hypercalcemia and high levels of vitamin d28)
Beskrivning

Sarcoidosis | Hypercalcemia | Increased vitamin D

Datatyp

boolean

Alias
UMLS CUI [1]
C0036202
UMLS CUI [2]
C0020437
UMLS CUI [3]
C0919765
subject has history of renal stones.
Beskrivning

Kidney Calculi

Datatyp

boolean

Alias
UMLS CUI [1]
C0022650
subject has hypercalcemia, which is defined as serum calcium levels >10.6 mg/dl, at the time of screening.
Beskrivning

Hypercalcemia | Serum Calcium Level

Datatyp

boolean

Alias
UMLS CUI [1]
C0020437
UMLS CUI [2]
C0036785
subject has end stage renal disease, defined as either chronic kidney disease stage v or requiring dialysis (since these patients have altered vitamin d and calcium metabolism).
Beskrivning

Kidney Failure, Chronic | Chronic Kidney Disease Staging | Dialysis Patient need for | Vitamin D metabolism altered | Calcium metabolism altered

Datatyp

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2,1]
C1561643
UMLS CUI [2,2]
C0449385
UMLS CUI [3,1]
C0011946
UMLS CUI [3,2]
C0686904
UMLS CUI [4,1]
C1159433
UMLS CUI [4,2]
C0392747
UMLS CUI [5,1]
C0596236
UMLS CUI [5,2]
C0392747
subject has systemic disease (including terminal cancer, cirrhosis, end stage copd etc.,) with reduced (<12 months) life expectancy.
Beskrivning

Systemic disease | End stage cancer | Liver Cirrhosis | End stage COPD | Reduced life expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0442893
UMLS CUI [2]
C0741884
UMLS CUI [3]
C0023890
UMLS CUI [4]
C4087491
UMLS CUI [5]
C1858274
subject has a history of psychiatric illness/condition that would interfere with his/her ability to understand or complete the requirements of the study.
Beskrivning

Mental disorders Interfere with Protocol Compliance | Mental condition Interferes with Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
subject has any condition that in the opinion of the investigator places the subject at an unacceptable risk as a participant in this study.
Beskrivning

Condition Study Subject Participation Status At risk Unacceptable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C1883420
subject is pregnant.
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Cardiovascular Disease NCT01018849

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent
Item
male or female of age > 19 years at the time informed consent is signed.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Angina, Unstable | TIMI Flow NSTEMI | TIMI Flow STEMI | Coronary Artery Disease | Coronary Occlusion Percentage Quantity
Item
subject with a diagnosis of unstable angina (with thrombolysis in myocardial infarction (timi) score of greater than or equal to 3) / nstemi or stemi,or documented coronary artery disease defined as at least one coronary artery with > 50% occlusion
boolean
C0002965 (UMLS CUI [1])
C3272266 (UMLS CUI [2,1])
C3537184 (UMLS CUI [2,2])
C3272266 (UMLS CUI [3,1])
C1536220 (UMLS CUI [3,2])
C1956346 (UMLS CUI [4])
C0151814 (UMLS CUI [5,1])
C0439165 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
Patient Available Follow-up visit
Item
subject who is able to come back to our clinic for follow up visits for at least 1 year after enrollment.
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0589121 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Phenytoin | Phenobarbital | orlistat
Item
subject is on treatment with either phenytoin or phenobarbitol or orlistat (since these medications may cause vitamin d deficiency).
boolean
C0031507 (UMLS CUI [1])
C0031412 (UMLS CUI [2])
C0076275 (UMLS CUI [3])
Comorbidity | Steroids Quantity per year Patient need for
Item
subject who needs two or more steroid bursts per year for other co-morbid conditions (since steroids may impair vitamin d metabolism).
boolean
C0009488 (UMLS CUI [1])
C0038317 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0439508 (UMLS CUI [2,3])
C0686904 (UMLS CUI [2,4])
Investigational New Drugs
Item
subject is on an investigational drug, which is a new drug class and not part of standard acs protocol.
boolean
C0013230 (UMLS CUI [1])
Vitamin D supplement Dose IU/day
Item
subject is taking supplements of vitamin d with doses >400 iu/day.
boolean
C3541352 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439465 (UMLS CUI [1,3])
Vitamin D allergy
Item
subject has hypersensitivity to vitamin d products.
boolean
C0571828 (UMLS CUI [1])
Lupus Erythematosus, Systemic
Item
subject has history of systemic lupus erythematosus (since vitamin d deficiency is common in this group27).
boolean
C0024141 (UMLS CUI [1])
Sarcoidosis | Hypercalcemia | Increased vitamin D
Item
subject has history of sarcoidosis (since they have hypercalcemia and high levels of vitamin d28)
boolean
C0036202 (UMLS CUI [1])
C0020437 (UMLS CUI [2])
C0919765 (UMLS CUI [3])
Kidney Calculi
Item
subject has history of renal stones.
boolean
C0022650 (UMLS CUI [1])
Hypercalcemia | Serum Calcium Level
Item
subject has hypercalcemia, which is defined as serum calcium levels >10.6 mg/dl, at the time of screening.
boolean
C0020437 (UMLS CUI [1])
C0036785 (UMLS CUI [2])
Kidney Failure, Chronic | Chronic Kidney Disease Staging | Dialysis Patient need for | Vitamin D metabolism altered | Calcium metabolism altered
Item
subject has end stage renal disease, defined as either chronic kidney disease stage v or requiring dialysis (since these patients have altered vitamin d and calcium metabolism).
boolean
C0022661 (UMLS CUI [1])
C1561643 (UMLS CUI [2,1])
C0449385 (UMLS CUI [2,2])
C0011946 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
C1159433 (UMLS CUI [4,1])
C0392747 (UMLS CUI [4,2])
C0596236 (UMLS CUI [5,1])
C0392747 (UMLS CUI [5,2])
Systemic disease | End stage cancer | Liver Cirrhosis | End stage COPD | Reduced life expectancy
Item
subject has systemic disease (including terminal cancer, cirrhosis, end stage copd etc.,) with reduced (<12 months) life expectancy.
boolean
C0442893 (UMLS CUI [1])
C0741884 (UMLS CUI [2])
C0023890 (UMLS CUI [3])
C4087491 (UMLS CUI [4])
C1858274 (UMLS CUI [5])
Mental disorders Interfere with Protocol Compliance | Mental condition Interferes with Protocol Compliance
Item
subject has a history of psychiatric illness/condition that would interfere with his/her ability to understand or complete the requirements of the study.
boolean
C0004936 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Condition Study Subject Participation Status At risk Unacceptable
Item
subject has any condition that in the opinion of the investigator places the subject at an unacceptable risk as a participant in this study.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C1883420 (UMLS CUI [1,4])
Pregnancy
Item
subject is pregnant.
boolean
C0032961 (UMLS CUI [1])
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