ID

35517

Beskrivning

Study of the Vascular Effects of Serelaxin; ODM derived from: https://clinicaltrials.gov/show/NCT01979614

Länk

https://clinicaltrials.gov/show/NCT01979614

Nyckelord

Versioner (1)
  1. 2019-03-07 2019-03-07 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

7 mars 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT01979614

Engelsk

Eligibility Coronary Artery Disease NCT01979614

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female patients ≥18 years of age, with body weight <160 kg.
Beskrivning

Age | Body Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0005910
patients with proven obstructive coronary artery disease, determined either by functional (e.g. treadmill testing) or non-invasive clinical imaging assessments (e.g. stress-echo, pet or spect myocardial perfusion), or invasive coronary angiography or by ct coronary angiography at any point in time in patients with or without mild left ventricular systolic dysfunction (lvsd)
Beskrivning

Obstructive Coronary Artery Disease Treadmill Test | Obstructive Coronary Artery Disease Diagnostic Imaging | Myocardial perfusion Stress Echocardiography | Myocardial perfusion PET | Myocardial perfusion SPECT | Coronary angiography | CT angiography of coronary arteries | Mild left ventricular systolic dysfunction | Mild left ventricular systolic dysfunction Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0549186
UMLS CUI [1,3]
C0087110
UMLS CUI [2,1]
C1956346
UMLS CUI [2,2]
C0549186
UMLS CUI [2,3]
C0011923
UMLS CUI [3,1]
C0428857
UMLS CUI [3,2]
C0920208
UMLS CUI [4,1]
C0428857
UMLS CUI [4,2]
C0032743
UMLS CUI [5,1]
C0428857
UMLS CUI [5,2]
C0040399
UMLS CUI [6]
C0085532
UMLS CUI [7]
C1634617
UMLS CUI [8]
C3266750
UMLS CUI [9,1]
C3266750
UMLS CUI [9,2]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with serelaxin (also known as: rlx030, relaxin)
Beskrivning

Serelaxin | Relaxin

Datatyp

boolean

Alias
UMLS CUI [1]
C3700393
UMLS CUI [2]
C0035031
women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment.
Beskrivning

Childbearing Potential | Exception Use of Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C0700589
current or planned dialysis.
Beskrivning

Dialysis | Dialysis Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0011946
UMLS CUI [2,1]
C0011946
UMLS CUI [2,2]
C1301732
impaired renal function during screening defined as an estimated glomerular filtration rate (egfr) at screening and prior to treatment of <30 ml/min/1.73 m2, calculated using the simplified modification of diet in renal disease (smdrd) equation due to potential issue with administration of gddtpa used as the mri contrast agent.
Beskrivning

Renal Insufficiency | Renal function GFR estimation by MDRD | Etiology aspects Gadolinium DTPA

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C2170215
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0060933
sick-sinus-syndrome
Beskrivning

Sick Sinus Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0037052
current or history of pulmonary edema, including suspected sepsis.
Beskrivning

Pulmonary Edema | Sepsis Suspected

Datatyp

boolean

Alias
UMLS CUI [1]
C0034063
UMLS CUI [2,1]
C0243026
UMLS CUI [2,2]
C0750491
restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on doppler echocardiographic assessments of diastolic function)
Beskrivning

Restrictive cardiomyopathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0007196
known significant valvular disease (including any of the following: severe aortic stenosis [ava < 1.0 or peak gradient > 50 on prior or current echocardiogram], severe aortic regurgitation, or severe mitral stenosis).
Beskrivning

Valvular disease | Severe aortic stenosis Aortic valve area | Severe aortic stenosis Echocardiography | AORTIC VALVE, REGURGITATION, ACUTE SEVERE | Mitral Valve Stenosis Severe

Datatyp

boolean

Alias
UMLS CUI [1]
C3258293
UMLS CUI [2,1]
C3806272
UMLS CUI [2,2]
C0428817
UMLS CUI [3,1]
C3806272
UMLS CUI [3,2]
C0013516
UMLS CUI [4]
C0237999
UMLS CUI [5,1]
C0026269
UMLS CUI [5,2]
C0205082
clinical diagnosis of acute coronary syndrome (acs) including unstable angina within 30 days prior to screening as determined by both clinical and enzymatic criteria
Beskrivning

Acute Coronary Syndrome | Angina, Unstable

Datatyp

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0002965
troponin elevation and dynamics indicative of acs at any time between screening and randomization.
Beskrivning

Troponin increased | Acute Coronary Syndrome Suspected

Datatyp

boolean

Alias
UMLS CUI [1]
C1141948
UMLS CUI [2,1]
C0948089
UMLS CUI [2,2]
C0750491
previous myocardial infarction within 3 months of screening
Beskrivning

Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
history of coronary artery bypass graft (cabg) surgery
Beskrivning

Coronary Artery Bypass Surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0010055
heart failure due to significant arrhythmias (including any of the following: ventricular tachycardia, bradyarrhythmias with ventricular rate < 45 beats per minute or any second or third degree av block or atrial fibrillation/flutter with ventricular response of > 120 beats per minute)
Beskrivning

Heart failure Due to Cardiac Arrhythmia | Tachycardia, Ventricular | Bradyarrhythmia Ventricular Heart Rate | Second degree atrioventricular block | Complete atrioventricular block | Atrial Fibrillation | Atrial Flutter

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0003811
UMLS CUI [2]
C0042514
UMLS CUI [3,1]
C0079035
UMLS CUI [3,2]
C1883530
UMLS CUI [4]
C0264906
UMLS CUI [5]
C0151517
UMLS CUI [6]
C0004238
UMLS CUI [7]
C0004239
any surgical or medical condition which in the opinion of the investigator may place the patient at higher risk from his/her participation in the study (e.g., history of poor tolerance of adenosine or 3 vessel coronary disease)
Beskrivning

Condition Surgical Study Subject Participation Status At risk | Medical condition Study Subject Participation Status At risk | Intolerance to Adenosine | Three Vessel Coronary Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C1444641
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0001443
UMLS CUI [4]
C3272265
acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on doppler echocardiographic assessments of diastolic function).
Beskrivning

Myocarditis | Hypertrophic Cardiomyopathy | Restrictive cardiomyopathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0027059
UMLS CUI [2]
C0007194
UMLS CUI [3]
C0007196
other protocol defined inclusion/exclusion criteria may apply
Beskrivning

Eligibility Criteria Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Coronary Artery Disease NCT01979614

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Body Weight
Item
male and female patients ≥18 years of age, with body weight <160 kg.
boolean
C0001779 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Obstructive Coronary Artery Disease Treadmill Test | Obstructive Coronary Artery Disease Diagnostic Imaging | Myocardial perfusion Stress Echocardiography | Myocardial perfusion PET | Myocardial perfusion SPECT | Coronary angiography | CT angiography of coronary arteries | Mild left ventricular systolic dysfunction | Mild left ventricular systolic dysfunction Absent
Item
patients with proven obstructive coronary artery disease, determined either by functional (e.g. treadmill testing) or non-invasive clinical imaging assessments (e.g. stress-echo, pet or spect myocardial perfusion), or invasive coronary angiography or by ct coronary angiography at any point in time in patients with or without mild left ventricular systolic dysfunction (lvsd)
boolean
C1956346 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
C0087110 (UMLS CUI [1,3])
C1956346 (UMLS CUI [2,1])
C0549186 (UMLS CUI [2,2])
C0011923 (UMLS CUI [2,3])
C0428857 (UMLS CUI [3,1])
C0920208 (UMLS CUI [3,2])
C0428857 (UMLS CUI [4,1])
C0032743 (UMLS CUI [4,2])
C0428857 (UMLS CUI [5,1])
C0040399 (UMLS CUI [5,2])
C0085532 (UMLS CUI [6])
C1634617 (UMLS CUI [7])
C3266750 (UMLS CUI [8])
C3266750 (UMLS CUI [9,1])
C0332197 (UMLS CUI [9,2])
Item Group
C0680251 (UMLS CUI)
Serelaxin | Relaxin
Item
previous treatment with serelaxin (also known as: rlx030, relaxin)
boolean
C3700393 (UMLS CUI [1])
C0035031 (UMLS CUI [2])
Childbearing Potential | Exception Use of Contraceptive methods
Item
women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment.
boolean
C3831118 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
Dialysis | Dialysis Planned
Item
current or planned dialysis.
boolean
C0011946 (UMLS CUI [1])
C0011946 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Renal Insufficiency | Renal function GFR estimation by MDRD | Etiology aspects Gadolinium DTPA
Item
impaired renal function during screening defined as an estimated glomerular filtration rate (egfr) at screening and prior to treatment of <30 ml/min/1.73 m2, calculated using the simplified modification of diet in renal disease (smdrd) equation due to potential issue with administration of gddtpa used as the mri contrast agent.
boolean
C1565489 (UMLS CUI [1])
C2170215 (UMLS CUI [2])
C0015127 (UMLS CUI [3,1])
C0060933 (UMLS CUI [3,2])
Sick Sinus Syndrome
Item
sick-sinus-syndrome
boolean
C0037052 (UMLS CUI [1])
Pulmonary Edema | Sepsis Suspected
Item
current or history of pulmonary edema, including suspected sepsis.
boolean
C0034063 (UMLS CUI [1])
C0243026 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Restrictive cardiomyopathy
Item
restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on doppler echocardiographic assessments of diastolic function)
boolean
C0007196 (UMLS CUI [1])
Valvular disease | Severe aortic stenosis Aortic valve area | Severe aortic stenosis Echocardiography | AORTIC VALVE, REGURGITATION, ACUTE SEVERE | Mitral Valve Stenosis Severe
Item
known significant valvular disease (including any of the following: severe aortic stenosis [ava < 1.0 or peak gradient > 50 on prior or current echocardiogram], severe aortic regurgitation, or severe mitral stenosis).
boolean
C3258293 (UMLS CUI [1])
C3806272 (UMLS CUI [2,1])
C0428817 (UMLS CUI [2,2])
C3806272 (UMLS CUI [3,1])
C0013516 (UMLS CUI [3,2])
C0237999 (UMLS CUI [4])
C0026269 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
Acute Coronary Syndrome | Angina, Unstable
Item
clinical diagnosis of acute coronary syndrome (acs) including unstable angina within 30 days prior to screening as determined by both clinical and enzymatic criteria
boolean
C0948089 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
Troponin increased | Acute Coronary Syndrome Suspected
Item
troponin elevation and dynamics indicative of acs at any time between screening and randomization.
boolean
C1141948 (UMLS CUI [1])
C0948089 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Myocardial Infarction
Item
previous myocardial infarction within 3 months of screening
boolean
C0027051 (UMLS CUI [1])
Coronary Artery Bypass Surgery
Item
history of coronary artery bypass graft (cabg) surgery
boolean
C0010055 (UMLS CUI [1])
Heart failure Due to Cardiac Arrhythmia | Tachycardia, Ventricular | Bradyarrhythmia Ventricular Heart Rate | Second degree atrioventricular block | Complete atrioventricular block | Atrial Fibrillation | Atrial Flutter
Item
heart failure due to significant arrhythmias (including any of the following: ventricular tachycardia, bradyarrhythmias with ventricular rate < 45 beats per minute or any second or third degree av block or atrial fibrillation/flutter with ventricular response of > 120 beats per minute)
boolean
C0018801 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0003811 (UMLS CUI [1,3])
C0042514 (UMLS CUI [2])
C0079035 (UMLS CUI [3,1])
C1883530 (UMLS CUI [3,2])
C0264906 (UMLS CUI [4])
C0151517 (UMLS CUI [5])
C0004238 (UMLS CUI [6])
C0004239 (UMLS CUI [7])
Condition Surgical Study Subject Participation Status At risk | Medical condition Study Subject Participation Status At risk | Intolerance to Adenosine | Three Vessel Coronary Disease
Item
any surgical or medical condition which in the opinion of the investigator may place the patient at higher risk from his/her participation in the study (e.g., history of poor tolerance of adenosine or 3 vessel coronary disease)
boolean
C0348080 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1444641 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C1744706 (UMLS CUI [3,1])
C0001443 (UMLS CUI [3,2])
C3272265 (UMLS CUI [4])
Myocarditis | Hypertrophic Cardiomyopathy | Restrictive cardiomyopathy
Item
acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on doppler echocardiographic assessments of diastolic function).
boolean
C0027059 (UMLS CUI [1])
C0007194 (UMLS CUI [2])
C0007196 (UMLS CUI [3])
Eligibility Criteria Study Protocol
Item
other protocol defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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