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])
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])