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
  Purpose
  • 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).

Condition Intervention
Chest Pain
Acute Coronary Syndrome
Other: Fast strategy
Other: Standard of care strategy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: High-Sensitivity Troponin T and Coronary Computed Tomography Angiography for Rapid Diagnosis of Emergency Chest Pain: a Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 101
Study Start Date: September 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fast strategy
High sensitivity cardiac troponin T followed by computed coronary tomography angiography
Other: Fast strategy
High sensitivity troponin T followed by computed coronary tomography angiography
Active Comparator: Standard of care strategy
Standard of care strategy based on serial electrocardiograms and cardiac biomarkers followed by stress/rest cardiac imaging study
Other: Standard of care strategy
Standard of care strategy: serial electrocardiograms and cardiac biomarkers followed by stress/rest cardiac imaging study

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01836211

Locations
Spain
Hospital de la Santa Cruz y San Pablo
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  More Information

No publications provided

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01836211     History of Changes
Other Study ID Numbers: IIBSP-DIA-2010-18
Study First Received: November 23, 2012
Last Updated: April 11, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Chest pain
Acute coronary syndrome
Cardiac biomarkers
Computed coronary tomography angiography
Emergency department

Additional relevant MeSH terms:
Chest Pain
Emergencies
Acute Coronary Syndrome
Pain
Signs and Symptoms
Disease Attributes
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014