ID

44690

Description

Acquiring Consensus for Contrast Echocardiography System Settings - ACCESS Study; ODM derived from: https://clinicaltrials.gov/show/NCT00669851

Link

https://clinicaltrials.gov/show/NCT00669851

Keywords

Versions (2)
  1. 2/23/17 2/23/17 -
  2. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00669851

English

Eligibility Coronary Artery Disease NCT00669851

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
for cohort a, men and non-pregnant/non-lactating women in good health who are 18 to 70 years of age and who have a low chance of cad will be enrolled.
Description

Age | Pregnancy | Breast Feeding | Overall Well Being | Coronary Artery Disease chance low

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4]
C3813622
UMLS CUI [5,1]
C1956346
UMLS CUI [5,2]
C0237506
UMLS CUI [5,3]
C0205251
for cohort b, men and non-pregnant/non-lactating women in good health who are 18-70 years of age who have had a prior mi and/or coronary artery revascularization intervention >90 days before ai-700 administration, without new or recurrent angina will be enrolled.
Description

Age | Pregnancy | Breast Feeding | Overall Well Being | Myocardial Infarction | Myocardial Revascularization | Coronary revascularisation | AI 700 | New onset angina | Angina pectoris recurrent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4]
C3813622
UMLS CUI [5]
C0027051
UMLS CUI [6]
C0027056
UMLS CUI [7]
C0877341
UMLS CUI [8]
C1671982
UMLS CUI [9]
C0340289
UMLS CUI [10]
C3805197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
healthy volunteers in cohort a who have or have had any of the following conditions will be excluded from the study: clinically significant intra-cardiac shunts or any other cardiovascular structural and/or severe functional abnormalities on the qualification echo, unless deemed not clinically relevant by the investigator and subsequently approved by the sponsor; ejection fraction (ef, estimated from the qualification echo) that is ≤55% (outside normal range), history or clinical manifestations of significant mental illness or significant pulmonary, hematological, renal, hepatic, central nervous, cardiovascular, genitourinary, or gastrointestinal disorders, or diabetes; history of any major surgical procedure within 90 days of screening/baseline; body mass index (bmi) >35; sitting systolic blood pressure <90 mmhg or >150 mmhg, diastolic blood pressure <50 mmhg or >95 mmhg, or a pulse rate <45 bpm or >90 bpm; oxygen saturation <92% at rest; and inadequate image quality on the qualification echo. other exclusion criteria include: participation in an investigational drug/device study within 30 days prior to dosing (90 days for uk sites), participation in a previous clinical trial of ai-700, non-seasonal asthma within the past 3 years or recent seasonal asthma requiring prescription medication, frequent (>5/min) premature ventricular or atrial contractions (pvc, pac), and any
Description

Healthy Volunteers | Multiple intracardiac shunts | Cardiovascular Abnormalities Echocardiography | Ejection fraction abnormal | Mental disorders | Lung diseases | Hematological Disease | Kidney Diseases | Liver diseases | CNS disorder | Cardiovascular Diseases | Disorder of the genitourinary system | Gastrointestinal Diseases | Diabetes Mellitus | major surgery | Body mass index | Sitting systolic blood pressure | Diastolic blood pressure | Pulse Rate | Oxygen saturation measurement At rest | image quality Inadequate Echocardiography | Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | AI 700 | Asthma | Seasonal asthma Requirement Prescription of drug | Premature ventricular contractions Frequent | PREMATURE ATRIAL CONTRACTION FREQUENT

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0685705
UMLS CUI [3,1]
C0243050
UMLS CUI [3,2]
C0013516
UMLS CUI [4]
C0855327
UMLS CUI [5]
C0004936
UMLS CUI [6]
C0024115
UMLS CUI [7]
C0018939
UMLS CUI [8]
C0022658
UMLS CUI [9]
C0023895
UMLS CUI [10]
C0007682
UMLS CUI [11]
C0007222
UMLS CUI [12]
C0080276
UMLS CUI [13]
C0017178
UMLS CUI [14]
C0011849
UMLS CUI [15]
C0679637
UMLS CUI [16]
C1305855
UMLS CUI [17]
C1319893
UMLS CUI [18]
C0428883
UMLS CUI [19]
C0232117
UMLS CUI [20,1]
C0523807
UMLS CUI [20,2]
C0443144
UMLS CUI [21,1]
C0806487
UMLS CUI [21,2]
C0205412
UMLS CUI [21,3]
C0013516
UMLS CUI [22]
C2348568
UMLS CUI [23]
C0013230
UMLS CUI [24]
C2346570
UMLS CUI [25]
C1671982
UMLS CUI [26]
C0004096
UMLS CUI [27,1]
C2919352
UMLS CUI [27,2]
C1514873
UMLS CUI [27,3]
C2239117
UMLS CUI [28,1]
C0151636
UMLS CUI [28,2]
C0332183
UMLS CUI [29]
C0747931
≥2nd av block, bundle branch block (bbb), or rhythm abnormality.
Description

Second degree atrioventricular block | Complete atrioventricular block | Bundle-Branch Block | Cardiac Arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
UMLS CUI [3]
C0006384
UMLS CUI [4]
C0003811
stable cardiac patients in cohorts a or b who have had any of the following conditions will be excluded from the study: any clinically unstable condition or major surgery within 30 days prior to screening/baseline (including but not limited to severe arterial hypertension, pulmonary hypertension, or any increase in pulmonary pressures due to increased pulmonary resistance, hypotension, bradycardia, tachycardia, unstable angina); cerebrovascular accident or transient ischemic attack within 90 days prior to dosing; congestive heart failure graded as new york heart association class 3 or 4 within 90 days prior to dosing; significant left main cad (≥50% stenosis); moderate to severe chronic obstructive pulmonary disease (copd) within 6 months prior to dosing; or oxygen saturation <90% at rest; and inadequate image quality on the qualification echo. candidates with clinically significant intra-cardiac shunts or any other cardiovascular structural and/or severe functional abnormalities per the qualification echo [including intra cardiac shunts; uncorrected congenital heart disease (i.e., severe valvular disease; large amount of pericardial effusion], ef (as estimated from the qualification echo) of <40%; are also not eligible to participate. subjects who exhibit new or changing ecg abnormalities at any time between screening and ai-700 dosing will be similarly excluded. other exclusion criteria include: participation in an investigational drug/device study within 30 days prior to dosing (90 days for uk sites), participation in a previous clinical trial of ai-700, 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. candidates will also be excluded for uncontrolled atrial fibrillation, frequent (>5/min) pvcs or pacs, history of prolonged qt/qtc (>500 msec), use of automatic implantable cardioverter/defibrillator, and any ≥2nd av block, bbb, or rhythm abnormality that has not been evaluated and treated by a specialist or for which current treatment is not adequately effective to the extent that subject safety is assured.
Description

Patients Cardiac Stable | Condition Clinical Unstable | major surgery | Hypertensive disease Severe | Pulmonary Hypertension | Pulmonary arterial pressure increased Due to pulmonary resistance increased | Hypotension | Bradycardia | Tachycardia | Angina, Unstable | Cerebrovascular accident | Transient Ischemic Attack | Congestive heart failure New York Heart Association Classification | Left main coronary artery disease | Moderate chronic obstructive pulmonary disease | Severe chronic obstructive pulmonary disease | Oxygen saturation measurement At rest | image quality Inadequate Echocardiography | intracardiac shunts | Cardiovascular Abnormalities Echocardiography | Congenital heart disease uncorrected | Valvular disease Severe | Pericardial effusion Large amount | Ejection fraction Echocardiography | ECG abnormality | Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | AI 700 | Asthma | Seasonal asthma Requirement Prescription of drug | Organ Transplantation | Organ dysfunction End-stage | Epilepsy | ATRIAL FIBRILLATION UNCONTROLLED | Premature ventricular contractions Frequent | PREMATURE ATRIAL CONTRACTION FREQUENT | Prolonged QT interval | Prolonged QTc | Automatic Implantable Cardioverter-Defibrillators | Second degree atrioventricular block | Complete atrioventricular block | Bundle-Branch Block | Cardiac Arrhythmia

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0018787
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0205210
UMLS CUI [2,3]
C0443343
UMLS CUI [3]
C0679637
UMLS CUI [4,1]
C0020538
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C0020542
UMLS CUI [6,1]
C0852853
UMLS CUI [6,2]
C0678226
UMLS CUI [6,3]
C0856941
UMLS CUI [7]
C0020649
UMLS CUI [8]
C0428977
UMLS CUI [9]
C0039231
UMLS CUI [10]
C0002965
UMLS CUI [11]
C0038454
UMLS CUI [12]
C0007787
UMLS CUI [13,1]
C0018802
UMLS CUI [13,2]
C1275491
UMLS CUI [14]
C1299433
UMLS CUI [15]
C0730605
UMLS CUI [16]
C0730607
UMLS CUI [17,1]
C0523807
UMLS CUI [17,2]
C0443144
UMLS CUI [18,1]
C0806487
UMLS CUI [18,2]
C0205412
UMLS CUI [18,3]
C0013516
UMLS CUI [19]
C0685705
UMLS CUI [20,1]
C0243050
UMLS CUI [20,2]
C0013516
UMLS CUI [21,1]
C0152021
UMLS CUI [21,2]
C4072785
UMLS CUI [22,1]
C3258293
UMLS CUI [22,2]
C0205082
UMLS CUI [23,1]
C0031039
UMLS CUI [23,2]
C3869890
UMLS CUI [24,1]
C0489482
UMLS CUI [24,2]
C0013516
UMLS CUI [25]
C0522055
UMLS CUI [26]
C2348568
UMLS CUI [27]
C0013230
UMLS CUI [28]
C2346570
UMLS CUI [29]
C1671982
UMLS CUI [30]
C0004096
UMLS CUI [31,1]
C2919352
UMLS CUI [31,2]
C1514873
UMLS CUI [31,3]
C2239117
UMLS CUI [32]
C0029216
UMLS CUI [33,1]
C0349410
UMLS CUI [33,2]
C0205088
UMLS CUI [34]
C0014544
UMLS CUI [35]
C0741284
UMLS CUI [36,1]
C0151636
UMLS CUI [36,2]
C0332183
UMLS CUI [37]
C0747931
UMLS CUI [38]
C0151878
UMLS CUI [39]
C1969409
UMLS CUI [40]
C0972395
UMLS CUI [41]
C0264906
UMLS CUI [42]
C0151517
UMLS CUI [43]
C0006384
UMLS CUI [44]
C0003811
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Similar models

Eligibility Coronary Artery Disease NCT00669851

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Pregnancy | Breast Feeding | Overall Well Being | Coronary Artery Disease chance low
Item
for cohort a, men and non-pregnant/non-lactating women in good health who are 18 to 70 years of age and who have a low chance of cad will be enrolled.
boolean
C0001779 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C3813622 (UMLS CUI [4])
C1956346 (UMLS CUI [5,1])
C0237506 (UMLS CUI [5,2])
C0205251 (UMLS CUI [5,3])
Age | Pregnancy | Breast Feeding | Overall Well Being | Myocardial Infarction | Myocardial Revascularization | Coronary revascularisation | AI 700 | New onset angina | Angina pectoris recurrent
Item
for cohort b, men and non-pregnant/non-lactating women in good health who are 18-70 years of age who have had a prior mi and/or coronary artery revascularization intervention >90 days before ai-700 administration, without new or recurrent angina will be enrolled.
boolean
C0001779 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C3813622 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C0027056 (UMLS CUI [6])
C0877341 (UMLS CUI [7])
C1671982 (UMLS CUI [8])
C0340289 (UMLS CUI [9])
C3805197 (UMLS CUI [10])
Item Group
C0680251 (UMLS CUI)
Healthy Volunteers | Multiple intracardiac shunts | Cardiovascular Abnormalities Echocardiography | Ejection fraction abnormal | Mental disorders | Lung diseases | Hematological Disease | Kidney Diseases | Liver diseases | CNS disorder | Cardiovascular Diseases | Disorder of the genitourinary system | Gastrointestinal Diseases | Diabetes Mellitus | major surgery | Body mass index | Sitting systolic blood pressure | Diastolic blood pressure | Pulse Rate | Oxygen saturation measurement At rest | image quality Inadequate Echocardiography | Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | AI 700 | Asthma | Seasonal asthma Requirement Prescription of drug | Premature ventricular contractions Frequent | PREMATURE ATRIAL CONTRACTION FREQUENT
Item
healthy volunteers in cohort a who have or have had any of the following conditions will be excluded from the study: clinically significant intra-cardiac shunts or any other cardiovascular structural and/or severe functional abnormalities on the qualification echo, unless deemed not clinically relevant by the investigator and subsequently approved by the sponsor; ejection fraction (ef, estimated from the qualification echo) that is ≤55% (outside normal range), history or clinical manifestations of significant mental illness or significant pulmonary, hematological, renal, hepatic, central nervous, cardiovascular, genitourinary, or gastrointestinal disorders, or diabetes; history of any major surgical procedure within 90 days of screening/baseline; body mass index (bmi) >35; sitting systolic blood pressure <90 mmhg or >150 mmhg, diastolic blood pressure <50 mmhg or >95 mmhg, or a pulse rate <45 bpm or >90 bpm; oxygen saturation <92% at rest; and inadequate image quality on the qualification echo. other exclusion criteria include: participation in an investigational drug/device study within 30 days prior to dosing (90 days for uk sites), participation in a previous clinical trial of ai-700, non-seasonal asthma within the past 3 years or recent seasonal asthma requiring prescription medication, frequent (>5/min) premature ventricular or atrial contractions (pvc, pac), and any
boolean
C1708335 (UMLS CUI [1])
C0685705 (UMLS CUI [2])
C0243050 (UMLS CUI [3,1])
C0013516 (UMLS CUI [3,2])
C0855327 (UMLS CUI [4])
C0004936 (UMLS CUI [5])
C0024115 (UMLS CUI [6])
C0018939 (UMLS CUI [7])
C0022658 (UMLS CUI [8])
C0023895 (UMLS CUI [9])
C0007682 (UMLS CUI [10])
C0007222 (UMLS CUI [11])
C0080276 (UMLS CUI [12])
C0017178 (UMLS CUI [13])
C0011849 (UMLS CUI [14])
C0679637 (UMLS CUI [15])
C1305855 (UMLS CUI [16])
C1319893 (UMLS CUI [17])
C0428883 (UMLS CUI [18])
C0232117 (UMLS CUI [19])
C0523807 (UMLS CUI [20,1])
C0443144 (UMLS CUI [20,2])
C0806487 (UMLS CUI [21,1])
C0205412 (UMLS CUI [21,2])
C0013516 (UMLS CUI [21,3])
C2348568 (UMLS CUI [22])
C0013230 (UMLS CUI [23])
C2346570 (UMLS CUI [24])
C1671982 (UMLS CUI [25])
C0004096 (UMLS CUI [26])
C2919352 (UMLS CUI [27,1])
C1514873 (UMLS CUI [27,2])
C2239117 (UMLS CUI [27,3])
C0151636 (UMLS CUI [28,1])
C0332183 (UMLS CUI [28,2])
C0747931 (UMLS CUI [29])
Second degree atrioventricular block | Complete atrioventricular block | Bundle-Branch Block | Cardiac Arrhythmia
Item
≥2nd av block, bundle branch block (bbb), or rhythm abnormality.
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
C0006384 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
Patients Cardiac Stable | Condition Clinical Unstable | major surgery | Hypertensive disease Severe | Pulmonary Hypertension | Pulmonary arterial pressure increased Due to pulmonary resistance increased | Hypotension | Bradycardia | Tachycardia | Angina, Unstable | Cerebrovascular accident | Transient Ischemic Attack | Congestive heart failure New York Heart Association Classification | Left main coronary artery disease | Moderate chronic obstructive pulmonary disease | Severe chronic obstructive pulmonary disease | Oxygen saturation measurement At rest | image quality Inadequate Echocardiography | intracardiac shunts | Cardiovascular Abnormalities Echocardiography | Congenital heart disease uncorrected | Valvular disease Severe | Pericardial effusion Large amount | Ejection fraction Echocardiography | ECG abnormality | Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | AI 700 | Asthma | Seasonal asthma Requirement Prescription of drug | Organ Transplantation | Organ dysfunction End-stage | Epilepsy | ATRIAL FIBRILLATION UNCONTROLLED | Premature ventricular contractions Frequent | PREMATURE ATRIAL CONTRACTION FREQUENT | Prolonged QT interval | Prolonged QTc | Automatic Implantable Cardioverter-Defibrillators | Second degree atrioventricular block | Complete atrioventricular block | Bundle-Branch Block | Cardiac Arrhythmia
Item
stable cardiac patients in cohorts a or b who have had any of the following conditions will be excluded from the study: any clinically unstable condition or major surgery within 30 days prior to screening/baseline (including but not limited to severe arterial hypertension, pulmonary hypertension, or any increase in pulmonary pressures due to increased pulmonary resistance, hypotension, bradycardia, tachycardia, unstable angina); cerebrovascular accident or transient ischemic attack within 90 days prior to dosing; congestive heart failure graded as new york heart association class 3 or 4 within 90 days prior to dosing; significant left main cad (≥50% stenosis); moderate to severe chronic obstructive pulmonary disease (copd) within 6 months prior to dosing; or oxygen saturation <90% at rest; and inadequate image quality on the qualification echo. candidates with clinically significant intra-cardiac shunts or any other cardiovascular structural and/or severe functional abnormalities per the qualification echo [including intra cardiac shunts; uncorrected congenital heart disease (i.e., severe valvular disease; large amount of pericardial effusion], ef (as estimated from the qualification echo) of <40%; are also not eligible to participate. subjects who exhibit new or changing ecg abnormalities at any time between screening and ai-700 dosing will be similarly excluded. other exclusion criteria include: participation in an investigational drug/device study within 30 days prior to dosing (90 days for uk sites), participation in a previous clinical trial of ai-700, 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. candidates will also be excluded for uncontrolled atrial fibrillation, frequent (>5/min) pvcs or pacs, history of prolonged qt/qtc (>500 msec), use of automatic implantable cardioverter/defibrillator, and any ≥2nd av block, bbb, or rhythm abnormality that has not been evaluated and treated by a specialist or for which current treatment is not adequately effective to the extent that subject safety is assured.
boolean
C0030705 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C0443343 (UMLS CUI [2,3])
C0679637 (UMLS CUI [3])
C0020538 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0020542 (UMLS CUI [5])
C0852853 (UMLS CUI [6,1])
C0678226 (UMLS CUI [6,2])
C0856941 (UMLS CUI [6,3])
C0020649 (UMLS CUI [7])
C0428977 (UMLS CUI [8])
C0039231 (UMLS CUI [9])
C0002965 (UMLS CUI [10])
C0038454 (UMLS CUI [11])
C0007787 (UMLS CUI [12])
C0018802 (UMLS CUI [13,1])
C1275491 (UMLS CUI [13,2])
C1299433 (UMLS CUI [14])
C0730605 (UMLS CUI [15])
C0730607 (UMLS CUI [16])
C0523807 (UMLS CUI [17,1])
C0443144 (UMLS CUI [17,2])
C0806487 (UMLS CUI [18,1])
C0205412 (UMLS CUI [18,2])
C0013516 (UMLS CUI [18,3])
C0685705 (UMLS CUI [19])
C0243050 (UMLS CUI [20,1])
C0013516 (UMLS CUI [20,2])
C0152021 (UMLS CUI [21,1])
C4072785 (UMLS CUI [21,2])
C3258293 (UMLS CUI [22,1])
C0205082 (UMLS CUI [22,2])
C0031039 (UMLS CUI [23,1])
C3869890 (UMLS CUI [23,2])
C0489482 (UMLS CUI [24,1])
C0013516 (UMLS CUI [24,2])
C0522055 (UMLS CUI [25])
C2348568 (UMLS CUI [26])
C0013230 (UMLS CUI [27])
C2346570 (UMLS CUI [28])
C1671982 (UMLS CUI [29])
C0004096 (UMLS CUI [30])
C2919352 (UMLS CUI [31,1])
C1514873 (UMLS CUI [31,2])
C2239117 (UMLS CUI [31,3])
C0029216 (UMLS CUI [32])
C0349410 (UMLS CUI [33,1])
C0205088 (UMLS CUI [33,2])
C0014544 (UMLS CUI [34])
C0741284 (UMLS CUI [35])
C0151636 (UMLS CUI [36,1])
C0332183 (UMLS CUI [36,2])
C0747931 (UMLS CUI [37])
C0151878 (UMLS CUI [38])
C1969409 (UMLS CUI [39])
C0972395 (UMLS CUI [40])
C0264906 (UMLS CUI [41])
C0151517 (UMLS CUI [42])
C0006384 (UMLS CUI [43])
C0003811 (UMLS CUI [44])
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