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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-06-30

Brief Summary

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* 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).

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Detailed Description

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Conditions

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Chest Pain Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Fast strategy

High sensitivity cardiac troponin T followed by computed coronary tomography angiography

Group Type EXPERIMENTAL

Fast strategy

Intervention Type OTHER

High sensitivity troponin T followed by computed coronary tomography angiography

Standard of care strategy

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

Group Type ACTIVE_COMPARATOR

Standard of care strategy

Intervention Type OTHER

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

Interventions

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Fast strategy

High sensitivity troponin T followed by computed coronary tomography angiography

Intervention Type OTHER

Standard of care strategy

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No