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

April 11, 2013 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Hospital de la Santa Cruz y San Pablo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Composite end-point.
1 month after index event

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial infarction
Time Frame: 1 month
1 month
All cause mortality
Time Frame: 1 month
1 month
Unstable angina
Time Frame: 1 month
1 month
Heart Failure
Time Frame: 1 month
1 month
Hospital admission
Time Frame: 1 month
New cardiovascular hospital admission
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

April 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

November 23, 2012

First Submitted That Met QC Criteria

April 11, 2013

First Posted (Estimate)

April 19, 2013

Study Record Updates

Last Update Posted (Estimate)

April 19, 2013

Last Update Submitted That Met QC Criteria

April 11, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-DIA-2010-18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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