High-Sensitivity Troponin T and Coronary Computed Tomography Angiography for Rapid Diagnosis of Emergency Chest Pain (TRUE)

This study has been terminated.
(low recruitment)
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT01836211
First received: November 23, 2012
Last updated: April 11, 2013
Last verified: April 2013

November 23, 2012
April 11, 2013
September 2011
April 2013   (final data collection date for primary outcome measure)
All cause mortality, new myocardial infarction, new unstable angina, new heart failure, new hospital admission, new consult to the Emergency Department [ Time Frame: 1 month after index event ] [ Designated as safety issue: Yes ]
Composite end-point.
Same as current
Complete list of historical versions of study NCT01836211 on ClinicalTrials.gov Archive Site
  • All cause mortality [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Unstable angina [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Heart Failure [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Hospital admission [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    New cardiovascular hospital admission
Same as current
Not Provided
Not Provided
 
High-Sensitivity Troponin T and Coronary Computed Tomography Angiography for Rapid Diagnosis of Emergency Chest Pain
High-Sensitivity Troponin T and Coronary Computed Tomography Angiography for Rapid Diagnosis of Emergency Chest Pain: a Randomized Controlled Study
  • 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).
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Chest Pain
  • Acute Coronary Syndrome
  • Other: Fast strategy
    High sensitivity troponin T followed by computed coronary tomography angiography
  • Other: Standard of care strategy
    Standard of care strategy: serial electrocardiograms and cardiac biomarkers followed by stress/rest cardiac imaging study
  • Experimental: Fast strategy
    High sensitivity cardiac troponin T followed by computed coronary tomography angiography
    Intervention: Other: Fast strategy
  • Active Comparator: Standard of care strategy
    Standard of care strategy based on serial electrocardiograms and cardiac biomarkers followed by stress/rest cardiac imaging study
    Intervention: Other: Standard of care strategy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
101
June 2013
April 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01836211
IIBSP-DIA-2010-18
Yes
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Not Provided
Not Provided
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP