ID

25798

Description

A Randomized Study to Demonstrate the Safety and Feasibility of Plexisyl-AF in Patients Undergoing Coronary Artery Bypass Grafting (CABG); ODM derived from: https://clinicaltrials.gov/show/NCT00562432

Link

https://clinicaltrials.gov/show/NCT00562432

Keywords

Versions (1)
  1. 9/20/17 9/20/17 -
Uploaded on

September 20, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00562432

English

Eligibility Atrial Fibrillation NCT00562432

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. the patients must be able and willing to give written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. the patients will be adult (age ≥ 18 years and </= 70 years) males or females who are scheduled to undergo on-pump open-chest coronary artery bypass grafting surgery of two (2) or more arteries.
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
3. the patients should be effectively treated prior to enrollment with an appropriate medical regimen (such as aspirin, ß-blockers, nitrates, and ace inhibitors). changes to medications after enrollment should be avoided.
Description

Therapeutic procedure | Aspirin | Adrenergic beta-Antagonists | Nitrates | Angiotensin-Converting Enzyme Inhibitors | Pharmaceutical Preparations unchanged

Data type

boolean

Alias
UMLS CUI [1]
C0087111
UMLS CUI [2]
C0004057
UMLS CUI [3]
C0001645
UMLS CUI [4]
C0028125
UMLS CUI [5]
C0003015
UMLS CUI [6,1]
C0013227
UMLS CUI [6,2]
C0442739
4. if female, the patients must be (a) post-menopausal, (b) surgically sterile or (c) using adequate birth control and have a negative pregnancy test within 7 days prior to administration of device.
Description

Postmenopausal state | Female Sterilization | Gender Contraceptive methods | Gender Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. emergent open heart surgery.
Description

Open heart surgery Emergency

Data type

boolean

Alias
UMLS CUI [1,1]
C0189745
UMLS CUI [1,2]
C0013956
2. patients scheduled to undergo mitral valve surgery, aortic, pulmonic or tricuspid valve replacements, and replacement or reconstruction of the aorta.
Description

Mitral valve operation Scheduled | Replacement of aortic valve Scheduled | Replacement of pulmonary valve Scheduled | Replacement of tricuspid valve Scheduled | Aorta Replacement Scheduled | Aorta reconstruction Scheduled

Data type

boolean

Alias
UMLS CUI [1,1]
C0519382
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C0003506
UMLS CUI [2,2]
C0205539
UMLS CUI [3,1]
C0190129
UMLS CUI [3,2]
C0205539
UMLS CUI [4,1]
C0190119
UMLS CUI [4,2]
C0205539
UMLS CUI [5,1]
C0003483
UMLS CUI [5,2]
C4076286
UMLS CUI [5,3]
C0205539
UMLS CUI [6,1]
C1293398
UMLS CUI [6,2]
C0205539
3. patients who have undergone a previous open chest cabg procedure.
Description

Coronary Artery Bypass Surgery Chest Open

Data type

boolean

Alias
UMLS CUI [1,1]
C0010055
UMLS CUI [1,2]
C0817096
UMLS CUI [1,3]
C0175566
4. previous history of atrial fibrillation or flutter.
Description

Atrial Fibrillation | Atrial Flutter

Data type

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C0004239
5. patient with clinical hypothyroidism or hyperthyroidism.
Description

Hypothyroidism | Hyperthyroidism

Data type

boolean

Alias
UMLS CUI [1]
C0020676
UMLS CUI [2]
C0020550
6. prophylactic medication for the prevention of atrial fibrillation or current use of an antiarrhythmic medication. patients who have been receiving beta-blockers and calcium channel blockers before screening may continue taking the medication.
Description

Drug prophylaxis Atrial Fibrillation | Anti-Arrhythmia Agents | Adrenergic beta-Antagonists allowed | Calcium Channel Blockers allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0420172
UMLS CUI [1,2]
C0004238
UMLS CUI [2]
C0003195
UMLS CUI [3,1]
C0001645
UMLS CUI [3,2]
C0683607
UMLS CUI [4,1]
C0006684
UMLS CUI [4,2]
C0683607
7. first-degree or higher degrees of atrioventricular (av) block (pr interval >210 msec)
Description

First degree atrioventricular block | Second degree atrioventricular block | Complete atrioventricular block | PR interval duration

Data type

boolean

Alias
UMLS CUI [1]
C0085614
UMLS CUI [2]
C0264906
UMLS CUI [3]
C0151517
UMLS CUI [4]
C0429024
8. an ejection fraction of less than 30%.
Description

Cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232174
9. clinically active congestive heart failure.
Description

Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018802
10. serum creatinine > 2.0 mg/dl or currently receiving dialysis.
Description

Creatinine measurement, serum | Dialysis Receiving

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2,1]
C0011946
UMLS CUI [2,2]
C1514756
11. clinically significant liver enzyme abnormalities (i.e., ast or alt more than two times the upper limit of normal and/or bilirubin more than 50% above the upper limit of normal).
Description

Liver enzymes abnormal | Aspartate aminotransferase increased | Alanine aminotransferase increased | Increased bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0438237
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0311468
12. the patients will not be receiving concurrently an investigational product in another clinical trial or have received an investigational product in another clinical trial in the 30 days prior to enrollment.
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
13. any other condition that, in the opinion of the clinical investigator, might compromise any aspect of the trial.
Description

Condition compromises Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0008976
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Similar models

Eligibility Atrial Fibrillation NCT00562432

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. the patients must be able and willing to give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Adult | Age
Item
2. the patients will be adult (age ≥ 18 years and </= 70 years) males or females who are scheduled to undergo on-pump open-chest coronary artery bypass grafting surgery of two (2) or more arteries.
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Therapeutic procedure | Aspirin | Adrenergic beta-Antagonists | Nitrates | Angiotensin-Converting Enzyme Inhibitors | Pharmaceutical Preparations unchanged
Item
3. the patients should be effectively treated prior to enrollment with an appropriate medical regimen (such as aspirin, ß-blockers, nitrates, and ace inhibitors). changes to medications after enrollment should be avoided.
boolean
C0087111 (UMLS CUI [1])
C0004057 (UMLS CUI [2])
C0001645 (UMLS CUI [3])
C0028125 (UMLS CUI [4])
C0003015 (UMLS CUI [5])
C0013227 (UMLS CUI [6,1])
C0442739 (UMLS CUI [6,2])
Postmenopausal state | Female Sterilization | Gender Contraceptive methods | Gender Pregnancy test negative
Item
4. if female, the patients must be (a) post-menopausal, (b) surgically sterile or (c) using adequate birth control and have a negative pregnancy test within 7 days prior to administration of device.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0427780 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Open heart surgery Emergency
Item
1. emergent open heart surgery.
boolean
C0189745 (UMLS CUI [1,1])
C0013956 (UMLS CUI [1,2])
Mitral valve operation Scheduled | Replacement of aortic valve Scheduled | Replacement of pulmonary valve Scheduled | Replacement of tricuspid valve Scheduled | Aorta Replacement Scheduled | Aorta reconstruction Scheduled
Item
2. patients scheduled to undergo mitral valve surgery, aortic, pulmonic or tricuspid valve replacements, and replacement or reconstruction of the aorta.
boolean
C0519382 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0003506 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
C0190129 (UMLS CUI [3,1])
C0205539 (UMLS CUI [3,2])
C0190119 (UMLS CUI [4,1])
C0205539 (UMLS CUI [4,2])
C0003483 (UMLS CUI [5,1])
C4076286 (UMLS CUI [5,2])
C0205539 (UMLS CUI [5,3])
C1293398 (UMLS CUI [6,1])
C0205539 (UMLS CUI [6,2])
Coronary Artery Bypass Surgery Chest Open
Item
3. patients who have undergone a previous open chest cabg procedure.
boolean
C0010055 (UMLS CUI [1,1])
C0817096 (UMLS CUI [1,2])
C0175566 (UMLS CUI [1,3])
Atrial Fibrillation | Atrial Flutter
Item
4. previous history of atrial fibrillation or flutter.
boolean
C0004238 (UMLS CUI [1])
C0004239 (UMLS CUI [2])
Hypothyroidism | Hyperthyroidism
Item
5. patient with clinical hypothyroidism or hyperthyroidism.
boolean
C0020676 (UMLS CUI [1])
C0020550 (UMLS CUI [2])
Drug prophylaxis Atrial Fibrillation | Anti-Arrhythmia Agents | Adrenergic beta-Antagonists allowed | Calcium Channel Blockers allowed
Item
6. prophylactic medication for the prevention of atrial fibrillation or current use of an antiarrhythmic medication. patients who have been receiving beta-blockers and calcium channel blockers before screening may continue taking the medication.
boolean
C0420172 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
C0003195 (UMLS CUI [2])
C0001645 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0006684 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
First degree atrioventricular block | Second degree atrioventricular block | Complete atrioventricular block | PR interval duration
Item
7. first-degree or higher degrees of atrioventricular (av) block (pr interval >210 msec)
boolean
C0085614 (UMLS CUI [1])
C0264906 (UMLS CUI [2])
C0151517 (UMLS CUI [3])
C0429024 (UMLS CUI [4])
Cardiac ejection fraction
Item
8. an ejection fraction of less than 30%.
boolean
C0232174 (UMLS CUI [1])
Congestive heart failure
Item
9. clinically active congestive heart failure.
boolean
C0018802 (UMLS CUI [1])
Creatinine measurement, serum | Dialysis Receiving
Item
10. serum creatinine > 2.0 mg/dl or currently receiving dialysis.
boolean
C0201976 (UMLS CUI [1])
C0011946 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
Liver enzymes abnormal | Aspartate aminotransferase increased | Alanine aminotransferase increased | Increased bilirubin
Item
11. clinically significant liver enzyme abnormalities (i.e., ast or alt more than two times the upper limit of normal and/or bilirubin more than 50% above the upper limit of normal).
boolean
C0438237 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0311468 (UMLS CUI [4])
Study Subject Participation Status | Investigational New Drugs
Item
12. the patients will not be receiving concurrently an investigational product in another clinical trial or have received an investigational product in another clinical trial in the 30 days prior to enrollment.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Condition compromises Clinical Trial
Item
13. any other condition that, in the opinion of the clinical investigator, might compromise any aspect of the trial.
boolean
C0348080 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
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