ID

11722

Description

The growing availability of cardiac computed tomography (CT)* in emergency departments (EDs) across the U.S. expands the opportunities for its clinical application, but also heightens the need to define its appropriate use in the evaluation of patients with acute chest pain. To address this need, we performed a randomized diagnostic trial (RDT) to determine whether integrating cardiac CT, along with the information it provides on coronary artery disease (CAD) and left ventricular (LV) function, can improve the efficiency of the management of these patients (i.e. shorten length of hospital stay, increase direct discharge rates from the ED, decreasing healthcare costs and improving cost effectiveness while being safe). https://clinicaltrials.gov/ct2/show/NCT01084239

Link

https://clinicaltrials.gov/ct2/show/NCT01084239

Keywords

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

July 28, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility ROMICAT-II Acute Coronary Syndrome NCT01084239

English

Eligibility Critera

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

Inclusion Criteria

Participant had at least five minutes of chest pain or equivalent (chest tightness; pain radiating to left, right, or both arms or shoulders, back, neck, epigastrium, jaw/throat; or unexplained shortness of breath, syncope/presyncope, generalized weakness, nausea, or vomiting thought to be of cardiac origin) at rest or during exercise within 24 hours of ED presentation, warranting further risk stratification, as determined by an ED attending.
Description

Participant had at least five minutes of chest pain or equivalent (chest tightness; pain radiating to left, right, or both arms or shoulders, back, neck, epigastrium, jaw/throat; or unexplained shortness of breath, syncope/presyncope, generalized weakness, nausea, or vomiting thought to be of cardiac origin) at rest or during exercise within 24 hours of ED presentation, warranting further risk stratification, as determined by an ED attending.

Data type

boolean

Alias
UMLS CUI-1
C0008031
2 or more cardiac risk factors (diabetes, hypertension, hyperlipidemia, current smoker and family history of coronary artery disease).
Description

2 or more cardiac risk factors (diabetes, hypertension, hyperlipidemia, current smoker and family history of coronary artery disease).

Data type

boolean

Alias
UMLS CUI-1
C2024776
Diabetes
Description

Diabetes

Data type

boolean

Alias
UMLS CUI-1
C0011849
Hypertension
Description

Hypertension

Data type

boolean

Alias
UMLS CUI-1
C0020538
Hyperlipidemia
Description

Hyperlipidemia

Data type

boolean

Alias
UMLS CUI-1
C0020473
Current smoker
Description

Current smoker

Data type

boolean

Alias
UMLS CUI-1
C3241966
family history of coronary artery disease
Description

family history of coronary artery disease

Data type

boolean

Alias
UMLS CUI-1
C2317524
Able to provide a written informed consent.
Description

Able to provide a written informed consent.

Data type

boolean

Alias
UMLS CUI-1
C0021430
<75 years of age, but >40 years of age.
Description

<75 years of age, but >40 years of age.

Data type

boolean

Alias
UMLS CUI-1
C0001779
Able to hold breath for at least 10 seconds.
Description

Able to hold breath for at least 10 seconds.

Data type

boolean

Alias
UMLS CUI-1
C0235744
Sinus rhythm.
Description

Sinus rhythm.

Data type

boolean

Alias
UMLS CUI-1
C0232201
Exclusion Criteria
Description

Exclusion Criteria

New diagnostic ischemic ECG changes in more than two anatomically adjacent leads or left bundle branch block
Description

New diagnostic ischemic ECG changes

Data type

boolean

Alias
UMLS CUI-1
C0474715
ST-segment elevation or depression > 1 mm
Description

ST-segment elevation or depression > 1 mm

Data type

boolean

Alias
UMLS CUI-1
C0520886
T-wave inversion > 4 mm
Description

T-wave inversion > 4 mm

Data type

boolean

Alias
UMLS CUI-1
C0520888
Documented or self-reported history of MI
Description

Documented or self-reported history of MI

Data type

boolean

Alias
UMLS CUI-1
C1275835
Documented or self-reported history of percutaneous coronary interventions [PCIs]
Description

Documented or self-reported history of percutaneous coronary interventions [PCIs]

Data type

boolean

Alias
UMLS CUI-1
C1320647
Documented or self-reported history of coronary artery bypass graft [CABG]
Description

Documented or self-reported history of coronary artery bypass graft [CABG]

Data type

boolean

Alias
UMLS CUI-1
C1842251
Documented or self-reported history of known significant coronary stenosis [>50%]
Description

Documented or self-reported history of known significant coronary stenosis [>50%]

Data type

boolean

Alias
UMLS CUI-1
C0242231
Greater than 6 hours since presentation to ED.
Description

Greater than 6 hours since presentation to ED.

Data type

boolean

Alias
UMLS CUI-1
C1320532
BMI >40 kg/m2
Description

BMI >40 kg/m2

Data type

boolean

Alias
UMLS CUI-1
C1305855
Impaired renal function as defined by serum creatinine >1.5 mg/dL*
Description

Impaired renal function as defined by serum creatinine >1.5 mg/dL*

Data type

boolean

Alias
UMLS CUI-1
C0035078
Impaired renal function as defined by serum creatinine >1.5 mg/dL*
Description

Impaired renal function as defined by serum creatinine >1.5 mg/dL*

Data type

boolean

Alias
UMLS CUI-1
C0201975
Elevated troponin-T (> 0.09 ng/ml)
Description

Elevated troponin-T (> 0.09 ng/ml)

Data type

boolean

Alias
UMLS CUI-1
C1141947
Hemodynamically or clinically unstable condition (BP systolic < 80 mm Hg, atrial or ventricular arrhythmias, persistent chest pain despite adequate therapy)
Description

Hemodynamically or clinically unstable condition (BP systolic < 80 mm Hg, atrial or ventricular arrhythmias, persistent chest pain despite adequate therapy)

Data type

boolean

Alias
UMLS CUI-1
C0948268
BP systolic < 80 mm Hg
Description

BP systolic < 80 mm Hg

Data type

boolean

Alias
UMLS CUI-1
C0871470
atrial or ventricular arrhythmias
Description

atrial or ventricular arrhythmias

Data type

boolean

Alias
UMLS CUI-1
C0085612
UMLS CUI-2
C0085611
persistent chest pain despite adequate therapy
Description

persistent chest pain despite adequate therapy

Data type

boolean

Alias
UMLS CUI-1
C0008031
Known allergy to iodinated contrast agent
Description

Known allergy to iodinated contrast agent

Data type

boolean

Alias
UMLS CUI-1
C0570562
Currently symptomatic asthma
Description

Currently symptomatic asthma

Data type

boolean

Alias
UMLS CUI-1
C0004096
Documented or self-reported cocaine use within the past 48 hours (acute)
Description

Documented or self-reported cocaine use within the past 48 hours (acute)

Data type

boolean

Alias
UMLS CUI-1
C0239076
On Metformin therapy and unable or unwilling to discontinue for 48 hours after the CT scan
Description

On Metformin therapy and unable or unwilling to discontinue for 48 hours after the CT scan

Data type

boolean

Alias
UMLS CUI-1
C0025598
Contraindication to beta blockers (taking daily antiasthmatic medication): This exclusion only applies to patients with a heart rate >65 bpm at sites using a non-dual source CT scanner
Description

Contraindication to beta blockers (taking daily antiasthmatic medication): This exclusion only applies to patients with a heart rate >65 bpm at sites using a non-dual source CT scanner

Data type

boolean

Alias
UMLS CUI-1
C1278474
Participant with no telephone or cell phone numbers or no address (preventing follow-up)
Description

Participant with no telephone or cell phone numbers or no address (preventing follow-up)

Data type

boolean

Alias
UMLS CUI-1
C1515258
Participant with positive pregnancy test. Women of childbearing potential, defined as <2 years of menopause in the absence of hysterectomy or tube ligation, must have a pregnancy test performed within 24 hours before the CT scan.
Description

Participant with positive pregnancy test. Women of childbearing potential, defined as <2 years of menopause in the absence of hysterectomy or tube ligation, must have a pregnancy test performed within 24 hours before the CT scan.

Data type

boolean

Alias
UMLS CUI-1
C0549206
Participant unwilling to provide a written informed consent.
Description

Participant unwilling to provide a written informed consent.

Data type

boolean

Alias
UMLS CUI-1
C0021430
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Similar models

Eligibility Critera

1 forms
  1. StudyEvent: ODM
    1. Eligibility Critera
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Chest pain
Item
Participant had at least five minutes of chest pain or equivalent (chest tightness; pain radiating to left, right, or both arms or shoulders, back, neck, epigastrium, jaw/throat; or unexplained shortness of breath, syncope/presyncope, generalized weakness, nausea, or vomiting thought to be of cardiac origin) at rest or during exercise within 24 hours of ED presentation, warranting further risk stratification, as determined by an ED attending.
boolean
C0008031 (UMLS CUI-1)
Cardiac risk factors
Item
2 or more cardiac risk factors (diabetes, hypertension, hyperlipidemia, current smoker and family history of coronary artery disease).
boolean
C2024776 (UMLS CUI-1)
Diabetes mellitus
Item
Diabetes
boolean
C0011849 (UMLS CUI-1)
Hypertension
Item
Hypertension
boolean
C0020538 (UMLS CUI-1)
Hyperlipidemia
Item
Hyperlipidemia
boolean
C0020473 (UMLS CUI-1)
Current smoker
Item
Current smoker
boolean
C3241966 (UMLS CUI-1)
family history of coronary artery disease
Item
family history of coronary artery disease
boolean
C2317524 (UMLS CUI-1)
Informed consent
Item
Able to provide a written informed consent.
boolean
C0021430 (UMLS CUI-1)
Age
Item
<75 years of age, but >40 years of age.
boolean
C0001779 (UMLS CUI-1)
Breath Holding
Item
Able to hold breath for at least 10 seconds.
boolean
C0235744 (UMLS CUI-1)
Sinus rhythm
Item
Sinus rhythm.
boolean
C0232201 (UMLS CUI-1)
Item Group
Exclusion Criteria
ECG myocardial ischemia
Item
New diagnostic ischemic ECG changes in more than two anatomically adjacent leads or left bundle branch block
boolean
C0474715 (UMLS CUI-1)
ST-segment elevation
Item
ST-segment elevation or depression > 1 mm
boolean
C0520886 (UMLS CUI-1)
T-wave inversion
Item
T-wave inversion > 4 mm
boolean
C0520888 (UMLS CUI-1)
History of MI
Item
Documented or self-reported history of MI
boolean
C1275835 (UMLS CUI-1)
Prior PCI
Item
Documented or self-reported history of percutaneous coronary interventions [PCIs]
boolean
C1320647 (UMLS CUI-1)
History of CABG
Item
Documented or self-reported history of coronary artery bypass graft [CABG]
boolean
C1842251 (UMLS CUI-1)
Coronary artery stenosis
Item
Documented or self-reported history of known significant coronary stenosis [>50%]
boolean
C0242231 (UMLS CUI-1)
Arrival at hospital
Item
Greater than 6 hours since presentation to ED.
boolean
C1320532 (UMLS CUI-1)
Body mass index
Item
BMI >40 kg/m2
boolean
C1305855 (UMLS CUI-1)
Kidney failure
Item
Impaired renal function as defined by serum creatinine >1.5 mg/dL*
boolean
C0035078 (UMLS CUI-1)
Serum creatinine
Item
Impaired renal function as defined by serum creatinine >1.5 mg/dL*
boolean
C0201975 (UMLS CUI-1)
Troponin T
Item
Elevated troponin-T (> 0.09 ng/ml)
boolean
C1141947 (UMLS CUI-1)
Hemodynamic instability
Item
Hemodynamically or clinically unstable condition (BP systolic < 80 mm Hg, atrial or ventricular arrhythmias, persistent chest pain despite adequate therapy)
boolean
C0948268 (UMLS CUI-1)
Systolic blood pressure
Item
BP systolic < 80 mm Hg
boolean
C0871470 (UMLS CUI-1)
Atrial or ventricular arrhythmias
Item
atrial or ventricular arrhythmias
boolean
C0085612 (UMLS CUI-1)
C0085611 (UMLS CUI-2)
Chest pain
Item
persistent chest pain despite adequate therapy
boolean
C0008031 (UMLS CUI-1)
Contrast media allergy
Item
Known allergy to iodinated contrast agent
boolean
C0570562 (UMLS CUI-1)
Asthma
Item
Currently symptomatic asthma
boolean
C0004096 (UMLS CUI-1)
Cocaine user
Item
Documented or self-reported cocaine use within the past 48 hours (acute)
boolean
C0239076 (UMLS CUI-1)
Metformin
Item
On Metformin therapy and unable or unwilling to discontinue for 48 hours after the CT scan
boolean
C0025598 (UMLS CUI-1)
Beta blocker contraindicated
Item
Contraindication to beta blockers (taking daily antiasthmatic medication): This exclusion only applies to patients with a heart rate >65 bpm at sites using a non-dual source CT scanner
boolean
C1278474 (UMLS CUI-1)
Phone number
Item
Participant with no telephone or cell phone numbers or no address (preventing follow-up)
boolean
C1515258 (UMLS CUI-1)
Pregnancy
Item
Participant with positive pregnancy test. Women of childbearing potential, defined as <2 years of menopause in the absence of hysterectomy or tube ligation, must have a pregnancy test performed within 24 hours before the CT scan.
boolean
C0549206 (UMLS CUI-1)
Informed consent
Item
Participant unwilling to provide a written informed consent.
boolean
C0021430 (UMLS CUI-1)
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