ID

37614

Descrição

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

Link

https://clinicaltrials.gov/show/NCT02177266

Palavras-chave

Versões (1)
  1. 11/08/2019 11/08/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

11 de agosto de 2019

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Atrial Fibrillation NCT02177266

Inglês

Eligibility Atrial Fibrillation NCT02177266

1 Formulários  
Criteria
Descrição

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.
Descrição

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

Tipo de dados

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.
Descrição

Informed Consent | Compliance Follow-up

Tipo de dados

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.
Descrição

Childbearing Potential Contraceptive methods

Tipo de dados

boolean

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

Exclusion Criteria

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

Exclusion Criteria Fulfill Baseline

Tipo de dados

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
Descrição

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

Tipo de dados

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)
Descrição

Permanent atrial fibrillation | Atrial Fibrillation

Tipo de dados

boolean

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

Colchicine allergy | Colchicine Therapy Pre-existing

Tipo de dados

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)
Descrição

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

Tipo de dados

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
Descrição

Gastrointestinal Disease Serious

Tipo de dados

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)
Descrição

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

Tipo de dados

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.
Descrição

Childbearing Potential Contraceptive methods Absent

Tipo de dados

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.
Descrição

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

Tipo de dados

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).
Descrição

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

Tipo de dados

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.
Descrição

Risk Rhabdomyolysis | Digoxin

Tipo de dados

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.
Descrição

Informed Consent Unable | Informed Consent Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
Voltar ao início da página

Similar models

Eligibility Atrial Fibrillation NCT02177266

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial