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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01836211

Acronym

TRUE

Enrollment

101

Registered

2013-04-19

Start date

2011-09-30

Completion date

2013-06-30

Last updated

2013-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Chest Pain

Keywords

Chest pain, Acute coronary syndrome, Cardiac biomarkers, Computed coronary tomography angiography, Emergency department

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).

Interventions

OTHERFast strategy

High sensitivity troponin T followed by computed coronary tomography angiography

OTHERStandard of care strategy

Standard of care strategy: serial electrocardiograms and cardiac biomarkers followed by stress/rest cardiac imaging study

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
All cause mortality, new myocardial infarction, new unstable angina, new heart failure, new hospital admission, new consult to the Emergency Department	1 month after index event	Composite end-point.

Secondary

Measure	Time frame	Description
All cause mortality	1 month	—
Myocardial infarction	1 month	—
Unstable angina	1 month	—
Heart Failure	1 month	—
Hospital admission	1 month	New cardiovascular hospital admission

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026