ID

39412

Beschreibung

Routine vs Selective Cardiac Magnetic Resonance in Non-Ischemic Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01281384

Link

https://clinicaltrials.gov/show/NCT01281384

Stichworte

Versionen (1)
  1. 09.01.20 09.01.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

9. Januar 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01281384

Englisch

Eligibility Heart Failure NCT01281384

1 Formulare  
Criteria
Beschreibung

Criteria

1. newly diagnosed hf within the past 12 months
Beschreibung

Heart failure Newly Diagnosed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1518321
2. established hf patients with deterioration/decompensation within the past 12 months
Beschreibung

Heart failure Established | Decompensation Recent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0443211
UMLS CUI [2,1]
C0231187
UMLS CUI [2,2]
C0332185
inclusion criteria: patients with new or worsening hf as above and
Beschreibung

Inclusion criteria | Heart failure Newly Diagnosed | Heart failure Worsening

Datentyp

boolean

Alias
UMLS CUI [1]
C1512693
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1518321
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C0332271
1. age > 18
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. working clinical diagnosis (known or highly suspected) of non-ischemic cardiomyopathy (nicm) or clinical diagnosis of hfpef (signs or symptoms of heart failure with a lvef
Beschreibung

Non-ischemic cardiomyopathy | Non-ischemic cardiomyopathy Suspected | HFpEF | Sign or Symptom Heart failure | Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0877438
UMLS CUI [2,1]
C0877438
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C4509226
UMLS CUI [4,1]
C3540840
UMLS CUI [4,2]
C0018801
UMLS CUI [5]
C0428772
≥ 40%)
Beschreibung

ID.6

Datentyp

boolean

3. documented history of class ii-iv nyha hf symptoms within the past 12 months
Beschreibung

Heart failure Symptoms New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C1275491
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior cmr and no major change in clinical condition
Beschreibung

Cardiovascular magnetic resonance imaging Previous | Medical condition unchanged

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3873775
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0442739
2. well-documented specific etiology (eg known amyloidosis or hemochromatosis)
Beschreibung

Etiology Specific | Amyloidosis | Hemochromatosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0205369
UMLS CUI [2]
C0002726
UMLS CUI [3]
C0018995
3. md considers cause of heart failure is attributable to obstructive cad.
Beschreibung

Heart failure | Etiology Coronary Artery Disease Obstructive

Datentyp

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C1956346
UMLS CUI [2,3]
C0549186
4. documented previous stemi (any territory) or nstemi in lad territory
Beschreibung

STEMI Previous | NSTEMI LAD

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1536220
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C4255010
UMLS CUI [2,2]
C0226032
5. severe medical conditions that significantly affect the patient's outcome (eg. active malignancy)
Beschreibung

Medical condition Severe Affecting Result | Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C1274040
UMLS CUI [2]
C0006826
6. ongoing need for advanced cardiac life support (eg iabp)
Beschreibung

Patient need for Advanced Cardiac Life Support | Intra-Aortic Balloon Pump

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0887907
UMLS CUI [2]
C0021860
7. severe valvular heart disease requiring surgery within the next 6 months
Beschreibung

Heart valve disease Severe | Requirement Operative Surgical Procedures

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0543467
8. contraindications to cmr (e.g. certain metallic implants, severe claustrophobia)
Beschreibung

Medical contraindication Cardiovascular magnetic resonance imaging | Metallic implant | Claustrophobia Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C3873775
UMLS CUI [2]
C3693688
UMLS CUI [3,1]
C0008909
UMLS CUI [3,2]
C0205082
9. contraindications to gadolinium contrast agent (gfr < 30ml/min/1,72m2, pregnancy)
Beschreibung

Medical contraindication Gadolinium-based Contrast Agent | Glomerular Filtration Rate | Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C3249258
UMLS CUI [2]
C0017654
UMLS CUI [3]
C0032961
10. inability to give informed consent
Beschreibung

Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
11. evidence of multivessel ischemia on stress imaging
Beschreibung

Blood Vessel Multiple Ischemia | Stress Imaging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005847
UMLS CUI [1,2]
C0439064
UMLS CUI [1,3]
C0022116
UMLS CUI [2,1]
C0038435
UMLS CUI [2,2]
C0011923
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Ähnliche Modelle

Eligibility Heart Failure NCT01281384

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Heart failure Newly Diagnosed
Item
1. newly diagnosed hf within the past 12 months
boolean
C0018801 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
Heart failure Established | Decompensation Recent
Item
2. established hf patients with deterioration/decompensation within the past 12 months
boolean
C0018801 (UMLS CUI [1,1])
C0443211 (UMLS CUI [1,2])
C0231187 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Inclusion criteria | Heart failure Newly Diagnosed | Heart failure Worsening
Item
inclusion criteria: patients with new or worsening hf as above and
boolean
C1512693 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1518321 (UMLS CUI [2,2])
C0018801 (UMLS CUI [3,1])
C0332271 (UMLS CUI [3,2])
Age
Item
1. age > 18
boolean
C0001779 (UMLS CUI [1])
Non-ischemic cardiomyopathy | Non-ischemic cardiomyopathy Suspected | HFpEF | Sign or Symptom Heart failure | Left ventricular ejection fraction
Item
2. working clinical diagnosis (known or highly suspected) of non-ischemic cardiomyopathy (nicm) or clinical diagnosis of hfpef (signs or symptoms of heart failure with a lvef
boolean
C0877438 (UMLS CUI [1])
C0877438 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C4509226 (UMLS CUI [3])
C3540840 (UMLS CUI [4,1])
C0018801 (UMLS CUI [4,2])
C0428772 (UMLS CUI [5])
ID.6
Item
≥ 40%)
boolean
Heart failure Symptoms New York Heart Association Classification
Item
3. documented history of class ii-iv nyha hf symptoms within the past 12 months
boolean
C0018801 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Cardiovascular magnetic resonance imaging Previous | Medical condition unchanged
Item
1. prior cmr and no major change in clinical condition
boolean
C3873775 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
Etiology Specific | Amyloidosis | Hemochromatosis
Item
2. well-documented specific etiology (eg known amyloidosis or hemochromatosis)
boolean
C0015127 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0002726 (UMLS CUI [2])
C0018995 (UMLS CUI [3])
Heart failure | Etiology Coronary Artery Disease Obstructive
Item
3. md considers cause of heart failure is attributable to obstructive cad.
boolean
C0018801 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C1956346 (UMLS CUI [2,2])
C0549186 (UMLS CUI [2,3])
STEMI Previous | NSTEMI LAD
Item
4. documented previous stemi (any territory) or nstemi in lad territory
boolean
C1536220 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C4255010 (UMLS CUI [2,1])
C0226032 (UMLS CUI [2,2])
Medical condition Severe Affecting Result | Malignant Neoplasms
Item
5. severe medical conditions that significantly affect the patient's outcome (eg. active malignancy)
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
C0006826 (UMLS CUI [2])
Patient need for Advanced Cardiac Life Support | Intra-Aortic Balloon Pump
Item
6. ongoing need for advanced cardiac life support (eg iabp)
boolean
C0686904 (UMLS CUI [1,1])
C0887907 (UMLS CUI [1,2])
C0021860 (UMLS CUI [2])
Heart valve disease Severe | Requirement Operative Surgical Procedures
Item
7. severe valvular heart disease requiring surgery within the next 6 months
boolean
C0018824 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
Medical contraindication Cardiovascular magnetic resonance imaging | Metallic implant | Claustrophobia Severe
Item
8. contraindications to cmr (e.g. certain metallic implants, severe claustrophobia)
boolean
C1301624 (UMLS CUI [1,1])
C3873775 (UMLS CUI [1,2])
C3693688 (UMLS CUI [2])
C0008909 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Medical contraindication Gadolinium-based Contrast Agent | Glomerular Filtration Rate | Pregnancy
Item
9. contraindications to gadolinium contrast agent (gfr < 30ml/min/1,72m2, pregnancy)
boolean
C1301624 (UMLS CUI [1,1])
C3249258 (UMLS CUI [1,2])
C0017654 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
Informed Consent Unable
Item
10. inability to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Blood Vessel Multiple Ischemia | Stress Imaging
Item
11. evidence of multivessel ischemia on stress imaging
boolean
C0005847 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0022116 (UMLS CUI [1,3])
C0038435 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
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