ID

42875

Description

Phase 3 Safety and Imaging Study of AI-700 in Patients With Suspected Coronary Artery Disease Undergoing Coronary Angiography; ODM derived from: https://clinicaltrials.gov/show/NCT00156845

Link

https://clinicaltrials.gov/show/NCT00156845

Keywords

Versions (2)
  1. 8/12/16 8/12/16 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00156845

English

Eligibility Coronary Artery Disease NCT00156845

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
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”
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4]
C0742292
UMLS CUI [5]
C0262384
UMLS CUI [6]
C0002962
UMLS CUI [7]
C0085532
UMLS CUI [8,1]
C0085532
UMLS CUI [8,2]
C1301732
UMLS CUI [9]
C1671982
UMLS CUI [10]
C0040399
UMLS CUI [11,1]
C1956346
UMLS CUI [11,2]
C0220825
spect within 15 days following ai-700 dosing.
Description

SPECT | AI 700

Data type

boolean

Alias
UMLS CUI [1]
C0040399
UMLS CUI [2]
C1671982
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0205210
UMLS CUI [2]
C0679637
UMLS CUI [3]
C1671982
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0007787
UMLS CUI [7]
C0018802
UMLS CUI [8]
C1275491
UMLS CUI [9,1]
C1299433
UMLS CUI [9,2]
C0750502
UMLS CUI [10]
C0010055
UMLS CUI [11]
C0730605
UMLS CUI [12]
C0730607
UMLS CUI [13,1]
C0523807
UMLS CUI [13,2]
C0443144
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C3277776
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C4021760
UMLS CUI [2,2]
C0678594
UMLS CUI [2,3]
C0750502
UMLS CUI [3,1]
C0232090
UMLS CUI [3,2]
C0750502
UMLS CUI [4,1]
C0476405
UMLS CUI [4,2]
C0750502
UMLS CUI [5,1]
C0225897
UMLS CUI [5,2]
C0011923
UMLS CUI [6,1]
C0232164
UMLS CUI [6,2]
C0220825
UMLS CUI [7]
C0013516
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.
Description

Myocardial Infarction Etiology aspects | Coronary Artery Disease | ECG abnormality New | ECG abnormality Changing | AI 700

Data type

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0015127
UMLS CUI [2]
C1956346
UMLS CUI [3,1]
C0522055
UMLS CUI [3,2]
C0205314
UMLS CUI [4,1]
C0522055
UMLS CUI [4,2]
C0392747
UMLS CUI [5]
C1671982
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.
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Asthma | Seasonal asthma Requirement Prescription of drug | Organ Transplantation | organ dysfunction End-stage | Epilepsy

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
UMLS CUI [4]
C0004096
UMLS CUI [5,1]
C2919352
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C2239117
UMLS CUI [6]
C0029216
UMLS CUI [7,1]
C0349410
UMLS CUI [7,2]
C0205088
UMLS CUI [8]
C0014544
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0741284
UMLS CUI [2,1]
C0151636
UMLS CUI [2,2]
C0332183
UMLS CUI [3]
C0747931
UMLS CUI [4]
C0151878
UMLS CUI [5]
C1969409
UMLS CUI [6]
C0972395
UMLS CUI [7]
C0030163
UMLS CUI [8]
C0003811
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.
Description

methylxanthine | Medical contraindication Aminophylline | Medical contraindication Theophylline | Medical contraindication Dipyridamole

Data type

boolean

Alias
UMLS CUI [1]
C0066447
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0002575
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0039771
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0012582
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Similar models

Eligibility Coronary Artery Disease NCT00156845

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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