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

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

Status: Terminated

Conditions: Acute Coronary Syndrome; Chest Pain

Treatments: Other: Fast strategy; Other: Standard of care strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT01836211

IIBSP-DIA-2010-18

Details and patient eligibility

About

• 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).

Enrollment: 101 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Fast strategy

Experimental group

Description:

High sensitivity cardiac troponin T followed by computed coronary tomography angiography

Treatment:

Other: Fast strategy

Standard of care strategy

Active Comparator group

Description:

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

Treatment:

Other: Standard of care strategy