ID

12469

Description

Clinical decision units (CDUs) improve resource utilization and are a recommended care option by the American College of Cardiology / American Heart Association, but are underutilized in non-low risk chest pain patients due to weaknesses of traditional cardiac testing. Cardiac magnetic resonance imaging (CMR) is sensitive and specific for ischemia, can simultaneously assess cardiac function and myocardial perfusion, and could revolutionize the diagnostic process for intermediate risk patients with chest pain. The primary objective of this trial is to measure the efficiency and safety of a combined CDU-CMR care pathway compared to inpatient care among patients with non-low risk acute chest pain. https://clinicaltrials.gov/ct2/show/NCT01035047

Link

https://clinicaltrials.gov/ct2/show/NCT01035047

Keywords

Versions (2)
  1. 7/28/15 7/28/15 -
  2. 11/21/15 11/21/15 -
Uploaded on

November 21, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Chest Pain Diagnostic Acute Coronary Syndrome NCT01035047

English

Eligibility Criteria

1 forms  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Age greater than or equal to 21 years of age at the time of enrollment
Description

Age greater than or equal to 21 years of age at the time of enrollment

Data type

boolean

Alias
UMLS CUI-1
C0001779
Chest discomfort or other symptoms consistent with possible ACS as indicated by the treating physician after obtaining an ECG and cardiac biomarkers for the patient's evaluation
Description

Chest discomfort or other symptoms consistent with possible ACS as indicated by the treating physician after obtaining an ECG and cardiac biomarkers for the patient's evaluation

Data type

boolean

Alias
UMLS CUI-1
C0948089
Thrombolysis in myocardial infarction (TIMI) risk score >/= 2 or physician impression of intermediate or high likelihood symptoms represent ACS
Description

Thrombolysis in myocardial infarction (TIMI) risk score >/= 2 or physician impression of intermediate or high likelihood symptoms represent ACS

Data type

boolean

Alias
UMLS CUI-1
C3272266
Patient requires an inpatient or CDU evaluation for their chest pain
Description

Patient requires an inpatient or CDU evaluation for their chest pain

Data type

boolean

Alias
UMLS CUI [1]
C0008031
Exclusion criteria
Description

Exclusion criteria

Elevated cardiac biomarkers
Description

Elevated cardiac biomarkers

Data type

boolean

Alias
UMLS CUI-1
C0741921
New ST-segment elevation on any electrocardiogram (>/= 1 mV)
Description

New ST-segment elevation on any electrocardiogram (>/= 1 mV)

Data type

boolean

Alias
UMLS CUI-1
C0520886
New ST-segment depression on any electrocardiogram (>/= 2 mV)
Description

New ST-segment depression on any electrocardiogram (>/= 2 mV)

Data type

boolean

Alias
UMLS CUI-1
C0520887
Known inducible cardiac ischemia without subsequent revascularization
Description

Known inducible cardiac ischemia without subsequent revascularization

Data type

boolean

Alias
UMLS CUI-1
C0151744
Unable to lie flat
Description

Unable to lie flat

Data type

boolean

Alias
UMLS CUI [1]
C1717946
Symptomatic hypotension at the time of enrollment (systolic < 90 mm Hg)
Description

Symptomatic hypotension at the time of enrollment (systolic < 90 mm Hg)

Data type

boolean

Alias
UMLS CUI-1
C0020649
Contra-indications to MRI (examples: Pacemaker, defibrillator, cerebral aneurysm clips, metallic ocular foreign body, implanted devices, severe claustrophobia)
Description

Contra-indications to MRI (examples: Pacemaker, defibrillator, cerebral aneurysm clips, metallic ocular foreign body, implanted devices, severe claustrophobia)

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0522473
Terminal diagnosis with life expectancy less than 3 months
Description

Terminal diagnosis with life expectancy less than 3 months

Data type

boolean

Alias
UMLS CUI-1
C0679247
Currently Pregnant
Description

Currently Pregnant

Data type

boolean

Alias
UMLS CUI-1
C0549206
Creatinine clearance < 45 ml/min at the time of enrollment or clinical concern for acute kidney injury
Description

Creatinine clearance < 45 ml/min at the time of enrollment or clinical concern for acute kidney injury

Data type

boolean

Alias
UMLS CUI-1
C0373595
Chronic liver disease with a creatinine clearance of <60 ml/min at the time of enrollment
Description

Chronic liver disease with a creatinine clearance of <60 ml/min at the time of enrollment

Data type

boolean

Alias
UMLS CUI-1
C0085605
Hepato-renal syndrome
Description

Hepato-renal syndrome

Data type

boolean

Alias
UMLS CUI-1
C0019212
History of liver transplant
Description

History of liver transplant

Data type

boolean

Alias
UMLS CUI-1
C0023911
History of heart transplant
Description

History of heart transplant

Data type

boolean

Alias
UMLS CUI-1
C0018823
History of kidney transplant
Description

History of kidney transplant

Data type

boolean

Alias
UMLS CUI-1
C0022671
Confirmed angioplasty
Description

Confirmed angioplasty

Data type

boolean

Alias
UMLS CUI-1
C0190211
Confirmed stent placement within the last 6 months
Description

Confirmed stent placement within the last 6 months

Data type

boolean

Alias
UMLS CUI-1
C3272316
Confirmed coronary artery bypass grafting (CABG) within the last 6 months
Description

Confirmed coronary artery bypass grafting (CABG) within the last 6 months

Data type

boolean

Alias
UMLS CUI-1
C0010055
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Age
Item
Age greater than or equal to 21 years of age at the time of enrollment
boolean
C0001779 (UMLS CUI-1)
Acute coronary syndrome
Item
Chest discomfort or other symptoms consistent with possible ACS as indicated by the treating physician after obtaining an ECG and cardiac biomarkers for the patient's evaluation
boolean
C0948089 (UMLS CUI-1)
TIMI
Item
Thrombolysis in myocardial infarction (TIMI) risk score >/= 2 or physician impression of intermediate or high likelihood symptoms represent ACS
boolean
C3272266 (UMLS CUI-1)
Chest pain
Item
Patient requires an inpatient or CDU evaluation for their chest pain
boolean
C0008031 (UMLS CUI [1])
Item Group
Exclusion criteria
Elevated cardiac biomarkers
Item
Elevated cardiac biomarkers
boolean
C0741921 (UMLS CUI-1)
ST-segment elevation
Item
New ST-segment elevation on any electrocardiogram (>/= 1 mV)
boolean
C0520886 (UMLS CUI-1)
ST-segment depression
Item
New ST-segment depression on any electrocardiogram (>/= 2 mV)
boolean
C0520887 (UMLS CUI-1)
Cardiac ischemia
Item
Known inducible cardiac ischemia without subsequent revascularization
boolean
C0151744 (UMLS CUI-1)
Unable to lie flat
Item
Unable to lie flat
boolean
C1717946 (UMLS CUI [1])
Hypotension
Item
Symptomatic hypotension at the time of enrollment (systolic < 90 mm Hg)
boolean
C0020649 (UMLS CUI-1)
Contraindications to MRI
Item
Contra-indications to MRI (examples: Pacemaker, defibrillator, cerebral aneurysm clips, metallic ocular foreign body, implanted devices, severe claustrophobia)
boolean
C0024485 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
Terminal illness
Item
Terminal diagnosis with life expectancy less than 3 months
boolean
C0679247 (UMLS CUI-1)
Pregnancy
Item
Currently Pregnant
boolean
C0549206 (UMLS CUI-1)
Creatinine clearance
Item
Creatinine clearance < 45 ml/min at the time of enrollment or clinical concern for acute kidney injury
boolean
C0373595 (UMLS CUI-1)
Liver failure
Item
Chronic liver disease with a creatinine clearance of <60 ml/min at the time of enrollment
boolean
C0085605 (UMLS CUI-1)
Hepatorenal syndrome
Item
Hepato-renal syndrome
boolean
C0019212 (UMLS CUI-1)
Liver transplant
Item
History of liver transplant
boolean
C0023911 (UMLS CUI-1)
Heart transplant
Item
History of heart transplant
boolean
C0018823 (UMLS CUI-1)
Kidney transplant
Item
History of kidney transplant
boolean
C0022671 (UMLS CUI-1)
Coronary angioplasty
Item
Confirmed angioplasty
boolean
C0190211 (UMLS CUI-1)
Cardiac stent placement
Item
Confirmed stent placement within the last 6 months
boolean
C3272316 (UMLS CUI-1)
CABG
Item
Confirmed coronary artery bypass grafting (CABG) within the last 6 months
boolean
C0010055 (UMLS CUI-1)
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