ID

28645

Beschreibung

Study of the Safety and Efficacy of Apadenoson for Detection of Myocardial Perfusion Defects Using SPECT MPI; ODM derived from: https://clinicaltrials.gov/show/NCT00990327

Link

https://clinicaltrials.gov/show/NCT00990327

Stichworte

Versionen (1)
  1. 25.01.18 25.01.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

25. Januar 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00990327

Englisch

Eligibility Coronary Artery Disease NCT00990327

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
high pretest probability of cad based on the acc/aha guidelines for relative risk, or past medical h/o cad
Beschreibung

Pretest Probability High Coronary Artery Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033101
UMLS CUI [1,2]
C0033204
UMLS CUI [1,3]
C0205250
UMLS CUI [1,4]
C1956346
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
ingestion of a caffeinated or methylxanthine food substance (e.g. chocolate, cocoa) within 24 hours before receiving apadenoson or adenosine
Beschreibung

Food caffeinated beverage | Food methylxanthine | Chocolate | Cocoa drink | Apadenoson | Adenosine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0016452
UMLS CUI [1,2]
C0678438
UMLS CUI [2,1]
C0016452
UMLS CUI [2,2]
C0066447
UMLS CUI [3]
C0008299
UMLS CUI [4]
C0452237
UMLS CUI [5]
C2698163
UMLS CUI [6]
C0001443
treatment with dipyridamole within 24 hours, or theophylline, aminophylline, or pentoxifylline within 72 hours (or 4 half-lives, whichever is longer) prior to receiving apadenoson or adenosine
Beschreibung

Dipyridamole | Theophylline | Aminophylline | Pentoxifylline | Apadenoson | Adenosine

Datentyp

boolean

Alias
UMLS CUI [1]
C0012582
UMLS CUI [2]
C0039771
UMLS CUI [3]
C0002575
UMLS CUI [4]
C0030899
UMLS CUI [5]
C2698163
UMLS CUI [6]
C0001443
acute mi, new onset of ischemia or pci within 30 days prior to spect-mpi at either period 1 or period 2; or cabg within 90 days prior to spect-mpi at either period 1 or period 2
Beschreibung

Myocardial Infarction | Ischemia new onset | Percutaneous Coronary Intervention | SPECT MPI | Coronary Artery Bypass Surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0022116
UMLS CUI [2,2]
C0746890
UMLS CUI [3]
C1532338
UMLS CUI [4,1]
C0040399
UMLS CUI [4,2]
C2350390
UMLS CUI [5]
C0010055
active severe asthma or severe chronic obstructive pulmonary disease (copd) which, in the investigator's opinion, places the subject at risk for severe bronchoconstriction
Beschreibung

Severe asthma | Chronic Obstructive Airway Disease Severe | Study Subject At risk Bronchoconstriction Severe

Datentyp

boolean

Alias
UMLS CUI [1]
C0581126
UMLS CUI [2,1]
C0024117
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0681850
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0079043
UMLS CUI [3,4]
C0205082
history or evidence of clinically significant cardiac condition and rhythm disorder, in the absence of a functioning permanently implanted pacemaker
Beschreibung

Cardiac problem | Cardiac Arrhythmia | Permanent pacemaker Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0262402
UMLS CUI [2]
C0003811
UMLS CUI [3,1]
C0281945
UMLS CUI [3,2]
C0332197
hemodynamically significant valvular disease, outflow tract obstruction, or uncontrolled severe hypertension
Beschreibung

Valvular disease Hemodynamic Significant | Obstruction of ventricular outflow tract | Uncontrolled hypertension Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3258293
UMLS CUI [1,2]
C0019010
UMLS CUI [1,3]
C0750502
UMLS CUI [2]
C3165151
UMLS CUI [3,1]
C1868885
UMLS CUI [3,2]
C0205082
current significant medical, surgical, psychiatric, or other illness or pathology that could potentiate any adverse pharmacological event associated with an investigational drug
Beschreibung

Adverse event pharmacological Associated with Investigational New Drugs | Etiology Illness | Etiology Operative Surgical Procedures | Etiology Mental disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0205464
UMLS CUI [1,3]
C0332281
UMLS CUI [1,4]
C0013230
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0221423
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0543467
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0004936
subject with past medical history of hepatitis b or c, or recent hepatitis a
Beschreibung

Hepatitis B | Hepatitis C | Hepatitis A

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019159
pretreatment hypotension (systolic bp < 90 mm hg) or tachycardia (hr > 100 bpm)
Beschreibung

Pretreatment Hypotension | Systolic Pressure | Tachycardia | heart rate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3539076
UMLS CUI [1,2]
C0020649
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0039231
UMLS CUI [4]
C0018810
known history of cerebral vascular accident or suspected transient ischemic attack within 30 days prior to signed informed consent
Beschreibung

Cerebrovascular accident | Suspected transient ischemic attack | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C3532623
UMLS CUI [3]
C0021430
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT00990327

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Pretest Probability High Coronary Artery Disease
Item
high pretest probability of cad based on the acc/aha guidelines for relative risk, or past medical h/o cad
boolean
C0033101 (UMLS CUI [1,1])
C0033204 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
C1956346 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Food caffeinated beverage | Food methylxanthine | Chocolate | Cocoa drink | Apadenoson | Adenosine
Item
ingestion of a caffeinated or methylxanthine food substance (e.g. chocolate, cocoa) within 24 hours before receiving apadenoson or adenosine
boolean
C0016452 (UMLS CUI [1,1])
C0678438 (UMLS CUI [1,2])
C0016452 (UMLS CUI [2,1])
C0066447 (UMLS CUI [2,2])
C0008299 (UMLS CUI [3])
C0452237 (UMLS CUI [4])
C2698163 (UMLS CUI [5])
C0001443 (UMLS CUI [6])
Dipyridamole | Theophylline | Aminophylline | Pentoxifylline | Apadenoson | Adenosine
Item
treatment with dipyridamole within 24 hours, or theophylline, aminophylline, or pentoxifylline within 72 hours (or 4 half-lives, whichever is longer) prior to receiving apadenoson or adenosine
boolean
C0012582 (UMLS CUI [1])
C0039771 (UMLS CUI [2])
C0002575 (UMLS CUI [3])
C0030899 (UMLS CUI [4])
C2698163 (UMLS CUI [5])
C0001443 (UMLS CUI [6])
Myocardial Infarction | Ischemia new onset | Percutaneous Coronary Intervention | SPECT MPI | Coronary Artery Bypass Surgery
Item
acute mi, new onset of ischemia or pci within 30 days prior to spect-mpi at either period 1 or period 2; or cabg within 90 days prior to spect-mpi at either period 1 or period 2
boolean
C0027051 (UMLS CUI [1])
C0022116 (UMLS CUI [2,1])
C0746890 (UMLS CUI [2,2])
C1532338 (UMLS CUI [3])
C0040399 (UMLS CUI [4,1])
C2350390 (UMLS CUI [4,2])
C0010055 (UMLS CUI [5])
Severe asthma | Chronic Obstructive Airway Disease Severe | Study Subject At risk Bronchoconstriction Severe
Item
active severe asthma or severe chronic obstructive pulmonary disease (copd) which, in the investigator's opinion, places the subject at risk for severe bronchoconstriction
boolean
C0581126 (UMLS CUI [1])
C0024117 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0681850 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0079043 (UMLS CUI [3,3])
C0205082 (UMLS CUI [3,4])
Cardiac problem | Cardiac Arrhythmia | Permanent pacemaker Absent
Item
history or evidence of clinically significant cardiac condition and rhythm disorder, in the absence of a functioning permanently implanted pacemaker
boolean
C0262402 (UMLS CUI [1])
C0003811 (UMLS CUI [2])
C0281945 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Valvular disease Hemodynamic Significant | Obstruction of ventricular outflow tract | Uncontrolled hypertension Severe
Item
hemodynamically significant valvular disease, outflow tract obstruction, or uncontrolled severe hypertension
boolean
C3258293 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C3165151 (UMLS CUI [2])
C1868885 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Adverse event pharmacological Associated with Investigational New Drugs | Etiology Illness | Etiology Operative Surgical Procedures | Etiology Mental disorders
Item
current significant medical, surgical, psychiatric, or other illness or pathology that could potentiate any adverse pharmacological event associated with an investigational drug
boolean
C0877248 (UMLS CUI [1,1])
C0205464 (UMLS CUI [1,2])
C0332281 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0015127 (UMLS CUI [2,1])
C0221423 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0004936 (UMLS CUI [4,2])
Hepatitis B | Hepatitis C | Hepatitis A
Item
subject with past medical history of hepatitis b or c, or recent hepatitis a
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019159 (UMLS CUI [3])
Pretreatment Hypotension | Systolic Pressure | Tachycardia | heart rate
Item
pretreatment hypotension (systolic bp < 90 mm hg) or tachycardia (hr > 100 bpm)
boolean
C3539076 (UMLS CUI [1,1])
C0020649 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0039231 (UMLS CUI [3])
C0018810 (UMLS CUI [4])
Cerebrovascular accident | Suspected transient ischemic attack | Informed Consent
Item
known history of cerebral vascular accident or suspected transient ischemic attack within 30 days prior to signed informed consent
boolean
C0038454 (UMLS CUI [1])
C3532623 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
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