Age | Pregnancy | Breast Feeding | CHEST PAIN CHAR TYPICAL | Atypical chest pain | Angina Pectoris | Coronary angiography | Coronary angiography Planned | AI 700 | SPECT | Coronary Artery Disease Evaluation
Item
men and non-pregnant/non-lactating women with a history of typical or atypical chest pain (angina) who were 18 to 80 years of age and who had recently undergone coronary angiography or were scheduled for coronary angiography within 30 days after ai-700 administration were to be enrolled. eligible patients must have also undergone spect for evaluation of cad within 45 calendar days prior to ai-700 administration, or be scheduled for an “on-study” spect on the same day as ai-700 dosing or an “off-study”
boolean
C0001779 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0742292 (UMLS CUI [4])
C0262384 (UMLS CUI [5])
C0002962 (UMLS CUI [6])
C0085532 (UMLS CUI [7])
C0085532 (UMLS CUI [8,1])
C1301732 (UMLS CUI [8,2])
C1671982 (UMLS CUI [9])
C0040399 (UMLS CUI [10])
C1956346 (UMLS CUI [11,1])
C0220825 (UMLS CUI [11,2])
SPECT | AI 700
Item
spect within 15 days following ai-700 dosing.
boolean
C0040399 (UMLS CUI [1])
C1671982 (UMLS CUI [2])
Condition Unstable Clinical | major surgery | AI 700 | Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack | Congestive heart failure | New York Heart Association Classification | Left main coronary artery disease Significant | Coronary Artery Bypass Surgery | Moderate chronic obstructive pulmonary disease | Severe chronic obstructive pulmonary disease | Oxygen saturation measurement At rest
Item
study candidates who have had any of the following conditions were to be excluded from the study: any clinically unstable condition or major surgery within 7 days prior to ai-700 dosing; an acute mi; cerebrovascular accident or transient ischemic attack within 30 days prior to dosing; congestive heart failure graded as new york heart association grade 4 within 3 months prior to dosing; significant left main cad; previous coronary artery bypass graft; moderate to severe chronic obstructive pulmonary disease; or oxygen saturation < 90% at rest.
boolean
C0348080 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0679637 (UMLS CUI [2])
C1671982 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
C0018802 (UMLS CUI [7])
C1275491 (UMLS CUI [8])
C1299433 (UMLS CUI [9,1])
C0750502 (UMLS CUI [9,2])
C0010055 (UMLS CUI [10])
C0730605 (UMLS CUI [11])
C0730607 (UMLS CUI [12])
C0523807 (UMLS CUI [13,1])
C0443144 (UMLS CUI [13,2])
Structural cardiovascular abnormalities Significant | Abnormality of the lung structural Significant | Abnormal cardiovascular function Significant | Lung function abnormal Significant | Left ventricular structure Imaging | Cardiac function Evaluation | Echocardiography
Item
candidates with significant cardiovascular or pulmonary structural and/or functional abnormality, or in whom visualization of the left ventricle was not adequate for evaluation of cardiac function during the exclusion echo, were to be ineligible to participate in the study.
boolean
C3277776 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C4021760 (UMLS CUI [2,1])
C0678594 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
C0232090 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
C0476405 (UMLS CUI [4,1])
C0750502 (UMLS CUI [4,2])
C0225897 (UMLS CUI [5,1])
C0011923 (UMLS CUI [5,2])
C0232164 (UMLS CUI [6,1])
C0220825 (UMLS CUI [6,2])
C0013516 (UMLS CUI [7])
Myocardial Infarction Etiology aspects | Coronary Artery Disease | ECG abnormality New | ECG abnormality Changing | AI 700
Item
patients who had a history of mi of non-cad etiology or who exhibited new or changing ecg abnormalities at any time between screening and ai-700 dosing were to be similarly excluded.
boolean
C0027051 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C1956346 (UMLS CUI [2])
C0522055 (UMLS CUI [3,1])
C0205314 (UMLS CUI [3,2])
C0522055 (UMLS CUI [4,1])
C0392747 (UMLS CUI [4,2])
C1671982 (UMLS CUI [5])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Asthma | Seasonal asthma Requirement Prescription of drug | Organ Transplantation | organ dysfunction End-stage | Epilepsy
Item
other exclusion criteria included: participation in an investigational drug/device study within 30 days prior to dosing (90 days in uk sites), non-seasonal asthma within the past 3 years or recent seasonal asthma requiring prescription medication, organ transplant or end-stage organ failure, and active seizure disorder.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
C0004096 (UMLS CUI [4])
C2919352 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C2239117 (UMLS CUI [5,3])
C0029216 (UMLS CUI [6])
C0349410 (UMLS CUI [7,1])
C0205088 (UMLS CUI [7,2])
C0014544 (UMLS CUI [8])
ATRIAL FIBRILLATION UNCONTROLLED | Premature ventricular contractions Frequent | PREMATURE ATRIAL CONTRACTION FREQUENT | Prolonged QT interval | Prolonged QTc | Automatic Implantable Cardioverter-Defibrillators | Artificial cardiac pacemaker | Cardiac Arrhythmia
Item
candidates were to be excluded for uncontrolled atrial fibrillation, frequent premature ventricular or atrial contractions, history of prolonged qt/qtc, use of automatic implantable cardioverter/defibrillator or pacemaker, and any rhythm abnormality that had not been evaluated and treated by a specialist or for which current treatment did not ensure patient safety.
boolean
C0741284 (UMLS CUI [1])
C0151636 (UMLS CUI [2,1])
C0332183 (UMLS CUI [2,2])
C0747931 (UMLS CUI [3])
C0151878 (UMLS CUI [4])
C1969409 (UMLS CUI [5])
C0972395 (UMLS CUI [6])
C0030163 (UMLS CUI [7])
C0003811 (UMLS CUI [8])
methylxanthine | Medical contraindication Aminophylline | Medical contraindication Theophylline | Medical contraindication Dipyridamole
Item
candidates who had used methylated xanthines within 24 hours of dosing were also to be excluded. patients were also to be excluded if aminophylline, theophylline, or dipyridamole were contraindicated according to each agent’s product labeling.
boolean
C0066447 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0002575 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0039771 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0012582 (UMLS CUI [4,2])