High-Sensitivity Troponin T and Coronary Computed Tomography Angiography for Rapid Diagnosis of Emergency Chest Pain (TRUE)
Primary Purpose
Chest Pain, Acute Coronary Syndrome
Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Fast strategy
Standard of care strategy
Sponsored by
About this trial
This is an interventional diagnostic trial for Chest Pain focused on measuring Chest pain, Acute coronary syndrome, Cardiac biomarkers, Computed coronary tomography angiography, Emergency department
Eligibility Criteria
Inclusion Criteria:
- Patients with chest pain consistent with possible acute coronary syndrome.
- Age > 18 years.
- Informed consent.
Exclusion Criteria:
- Previous history of coronary artery disease.
- Electrocardiogram diagnostic or suggestive of myocardial ischemia.
- Condition other than coronary artery disease as cause of an imbalance between myocardial oxygen supply and/or demand (eg. anemia, fever, arrhythmias).
- Chronic kidney disease (GFR <30 mL/min/1,73 m2).
- Iodine contrast allergy.
- Incapability to perform treadmill stress test.
- Barthel activity of daily living scale index < 100.
Sites / Locations
- Hospital de la Santa Cruz y San Pablo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fast strategy
Standard of care strategy
Arm Description
High sensitivity cardiac troponin T followed by computed coronary tomography angiography
Standard of care strategy based on serial electrocardiograms and cardiac biomarkers followed by stress/rest cardiac imaging study
Outcomes
Primary Outcome Measures
All cause mortality, new myocardial infarction, new unstable angina, new heart failure, new hospital admission, new consult to the Emergency Department
Composite end-point.
Secondary Outcome Measures
All cause mortality
Myocardial infarction
Unstable angina
Heart Failure
Hospital admission
New cardiovascular hospital admission
Full Information
NCT ID
NCT01836211
First Posted
November 23, 2012
Last Updated
April 11, 2013
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1. Study Identification
Unique Protocol Identification Number
NCT01836211
Brief Title
High-Sensitivity Troponin T and Coronary Computed Tomography Angiography for Rapid Diagnosis of Emergency Chest Pain
Acronym
TRUE
Official Title
High-Sensitivity Troponin T and Coronary Computed Tomography Angiography for Rapid Diagnosis of Emergency Chest Pain: a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Terminated
Why Stopped
low recruitment
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the efficacy and safety of an evaluation strategy based on utilization of high sensitivity cardiac troponin T (hscTnT), followed by coronary computed tomography angiography (CCTA) in patients with low-intermediate risk chest pain consistent with a possible acute coronary syndrome compared to a standard of care (SOC) strategy.
Unicentric, randomized, controlled, open label clinical trial that will compare a fast strategy (hscTnT followed by CCTA) with a SOC strategy (serial ECG and cardiac biomarkers followed by stress/rest imaging study).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Acute Coronary Syndrome
Keywords
Chest pain, Acute coronary syndrome, Cardiac biomarkers, Computed coronary tomography angiography, Emergency department
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fast strategy
Arm Type
Experimental
Arm Description
High sensitivity cardiac troponin T followed by computed coronary tomography angiography
Arm Title
Standard of care strategy
Arm Type
Active Comparator
Arm Description
Standard of care strategy based on serial electrocardiograms and cardiac biomarkers followed by stress/rest cardiac imaging study
Intervention Type
Other
Intervention Name(s)
Fast strategy
Intervention Description
High sensitivity troponin T followed by computed coronary tomography angiography
Intervention Type
Other
Intervention Name(s)
Standard of care strategy
Intervention Description
Standard of care strategy: serial electrocardiograms and cardiac biomarkers followed by stress/rest cardiac imaging study
Primary Outcome Measure Information:
Title
All cause mortality, new myocardial infarction, new unstable angina, new heart failure, new hospital admission, new consult to the Emergency Department
Description
Composite end-point.
Time Frame
1 month after index event
Secondary Outcome Measure Information:
Title
All cause mortality
Time Frame
1 month
Title
Myocardial infarction
Time Frame
1 month
Title
Unstable angina
Time Frame
1 month
Title
Heart Failure
Time Frame
1 month
Title
Hospital admission
Description
New cardiovascular hospital admission
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with chest pain consistent with possible acute coronary syndrome.
Age > 18 years.
Informed consent.
Exclusion Criteria:
Previous history of coronary artery disease.
Electrocardiogram diagnostic or suggestive of myocardial ischemia.
Condition other than coronary artery disease as cause of an imbalance between myocardial oxygen supply and/or demand (eg. anemia, fever, arrhythmias).
Chronic kidney disease (GFR <30 mL/min/1,73 m2).
Iodine contrast allergy.
Incapability to perform treadmill stress test.
Barthel activity of daily living scale index < 100.
Facility Information:
Facility Name
Hospital de la Santa Cruz y San Pablo
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
High-Sensitivity Troponin T and Coronary Computed Tomography Angiography for Rapid Diagnosis of Emergency Chest Pain
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