ID

37614

Description

Colchicine to Prevent Post-Pericardiotomy Syndrome and Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT02177266

Link

https://clinicaltrials.gov/show/NCT02177266

Keywords

  1. 8/11/19 8/11/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 11, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Atrial Fibrillation NCT02177266

Eligibility Atrial Fibrillation NCT02177266

Criteria
Description

Criteria

all consecutive adult patients (age > 40) undergoing standard (non-minimally invasive) coronary artery bypass surgery and/or aortic valve surgery will be approached for enrollment.
Description

Adult | Age | Coronary Artery Bypass Surgery Standard | Surgical Procedures on the Aortic Valve

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0010055
UMLS CUI [3,2]
C1442989
UMLS CUI [4]
C0519381
all patients must be able to provide informed consent and comply with the 3 month follow-up.
Description

Informed Consent | Compliance Follow-up

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C3274571
for women of reproductive capability, contraception is necessary and required.
Description

Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
all candidates meeting any of the exclusion criteria at baseline will be excluded from study participation:
Description

Exclusion Criteria Fulfill Baseline

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C1442488
egfr < 30 ml/min/1.73 m2, serum creatinine > 2.5 mg/dl or requiring dialysis
Description

Estimated Glomerular Filtration Rate | Creatinine measurement, serum | Requirement Dialysis

Data type

boolean

Alias
UMLS CUI [1]
C3811844
UMLS CUI [2]
C0201976
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0011946
known permanent or current atrial fibrillation (history of paroxysmal atrial fibrillation allowed if in sinus rhythm at present)
Description

Permanent atrial fibrillation | Atrial Fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C2586056
UMLS CUI [2]
C0004238
allergy to colchicine or already treated with colchicine.
Description

Colchicine allergy | Colchicine Therapy Pre-existing

Data type

boolean

Alias
UMLS CUI [1]
C0571131
UMLS CUI [2,1]
C0009262
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C2347662
known blood dyscrasia (acute or chronic leukemia, pancytopenia, aplastic anemia, leukopenia)
Description

Hematological Disease | Leukemia | Chronic leukemia | Pancytopenia | Aplastic Anemia | Leukopenia

Data type

boolean

Alias
UMLS CUI [1]
C0018939
UMLS CUI [2]
C0023418
UMLS CUI [3]
C1279296
UMLS CUI [4]
C0030312
UMLS CUI [5]
C0002874
UMLS CUI [6]
C0023530
known serious gastrointestinal disease
Description

Gastrointestinal Disease Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0205404
known severe liver disease (cirrhosis, ast/alt > 2x the upper limit of normal, meld score > 20)
Description

Liver disease Severe | Liver Cirrhosis | Aspartate aminotransferase increased | Alanine aminotransferase increased | MELD score

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0023890
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151905
UMLS CUI [5]
C1718072
women of childbearing potential not using contraception.
Description

Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
patients with hiv or aids as the use of protease inhibitors can result in serious colchicine toxicity.
Description

HIV Infection | AIDS | Protease Inhibitors Resulting in Poisoning by colchicine

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0001175
UMLS CUI [3,1]
C0033607
UMLS CUI [3,2]
C0332294
UMLS CUI [3,3]
C0274779
patients who are treated with strong cyp3a4 inhibitors (clarithromycin/erythyromycin, chloramphenicol, ketoconazole/itraconazole, and nefazodone).
Description

CYP3A4 Inhibitors Strong | Clarithromycin | Erythromycin | Chloramphenicol | Ketoconazole | Itraconazole | nefazodone

Data type

boolean

Alias
UMLS CUI [1,1]
C3850053
UMLS CUI [1,2]
C0442821
UMLS CUI [2]
C0055856
UMLS CUI [3]
C0014806
UMLS CUI [4]
C0008168
UMLS CUI [5]
C0022625
UMLS CUI [6]
C0064113
UMLS CUI [7]
C0068485
there is a risk of rhabdomyolysis with the use of digoxin and colchicine, we will exclude patients who require ongoing treatment with digoxin.
Description

Risk Rhabdomyolysis | Digoxin

Data type

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0035410
UMLS CUI [2]
C0012265
inability or unwillingness of the individual to give written informed consent.
Description

Informed Consent Unable | Informed Consent Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080

Similar models

Eligibility Atrial Fibrillation NCT02177266

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adult | Age | Coronary Artery Bypass Surgery Standard | Surgical Procedures on the Aortic Valve
Item
all consecutive adult patients (age > 40) undergoing standard (non-minimally invasive) coronary artery bypass surgery and/or aortic valve surgery will be approached for enrollment.
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0010055 (UMLS CUI [3,1])
C1442989 (UMLS CUI [3,2])
C0519381 (UMLS CUI [4])
Informed Consent | Compliance Follow-up
Item
all patients must be able to provide informed consent and comply with the 3 month follow-up.
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods
Item
for women of reproductive capability, contraception is necessary and required.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Fulfill Baseline
Item
all candidates meeting any of the exclusion criteria at baseline will be excluded from study participation:
boolean
C0680251 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,3])
Estimated Glomerular Filtration Rate | Creatinine measurement, serum | Requirement Dialysis
Item
egfr < 30 ml/min/1.73 m2, serum creatinine > 2.5 mg/dl or requiring dialysis
boolean
C3811844 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0011946 (UMLS CUI [3,2])
Permanent atrial fibrillation | Atrial Fibrillation
Item
known permanent or current atrial fibrillation (history of paroxysmal atrial fibrillation allowed if in sinus rhythm at present)
boolean
C2586056 (UMLS CUI [1])
C0004238 (UMLS CUI [2])
Colchicine allergy | Colchicine Therapy Pre-existing
Item
allergy to colchicine or already treated with colchicine.
boolean
C0571131 (UMLS CUI [1])
C0009262 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C2347662 (UMLS CUI [2,3])
Hematological Disease | Leukemia | Chronic leukemia | Pancytopenia | Aplastic Anemia | Leukopenia
Item
known blood dyscrasia (acute or chronic leukemia, pancytopenia, aplastic anemia, leukopenia)
boolean
C0018939 (UMLS CUI [1])
C0023418 (UMLS CUI [2])
C1279296 (UMLS CUI [3])
C0030312 (UMLS CUI [4])
C0002874 (UMLS CUI [5])
C0023530 (UMLS CUI [6])
Gastrointestinal Disease Serious
Item
known serious gastrointestinal disease
boolean
C0017178 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Liver disease Severe | Liver Cirrhosis | Aspartate aminotransferase increased | Alanine aminotransferase increased | MELD score
Item
known severe liver disease (cirrhosis, ast/alt > 2x the upper limit of normal, meld score > 20)
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
C1718072 (UMLS CUI [5])
Childbearing Potential Contraceptive methods Absent
Item
women of childbearing potential not using contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
HIV Infection | AIDS | Protease Inhibitors Resulting in Poisoning by colchicine
Item
patients with hiv or aids as the use of protease inhibitors can result in serious colchicine toxicity.
boolean
C0019693 (UMLS CUI [1])
C0001175 (UMLS CUI [2])
C0033607 (UMLS CUI [3,1])
C0332294 (UMLS CUI [3,2])
C0274779 (UMLS CUI [3,3])
CYP3A4 Inhibitors Strong | Clarithromycin | Erythromycin | Chloramphenicol | Ketoconazole | Itraconazole | nefazodone
Item
patients who are treated with strong cyp3a4 inhibitors (clarithromycin/erythyromycin, chloramphenicol, ketoconazole/itraconazole, and nefazodone).
boolean
C3850053 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C0055856 (UMLS CUI [2])
C0014806 (UMLS CUI [3])
C0008168 (UMLS CUI [4])
C0022625 (UMLS CUI [5])
C0064113 (UMLS CUI [6])
C0068485 (UMLS CUI [7])
Risk Rhabdomyolysis | Digoxin
Item
there is a risk of rhabdomyolysis with the use of digoxin and colchicine, we will exclude patients who require ongoing treatment with digoxin.
boolean
C0035647 (UMLS CUI [1,1])
C0035410 (UMLS CUI [1,2])
C0012265 (UMLS CUI [2])
Informed Consent Unable | Informed Consent Unwilling
Item
inability or unwillingness of the individual to give written informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])

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