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

Not Applicable

Terminated

• Conditions: Chest Pain; Acute Coronary Syndrome
• Interventions: Other: Fast strategy; Other: Standard of care strategy

• Registration Number: NCT01836211
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-11-23
• Status Verified: 2013-04
• Primary Completion: 2013-04
• Study First Submitted QC: 2013-04-11
• Last Update Submitted: 2013-04-11
• Study First Posted: 2013-04-19
• Last Update Posted: 2013-04-19
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fast strategy	Fast strategy	High sensitivity cardiac troponin T followed by computed coronary tomography angiography
Standard of care strategy	Standard of care strategy	Standard of care strategy based on serial electrocardiograms and cardiac biomarkers followed by stress/rest cardiac imaging study

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Heart Failure	1 month
All cause mortality	1 month
Myocardial infarction	1 month
Unstable angina	1 month
Hospital admission	1 month	New cardiovascular hospital admission

Trial Locations

Locations (1)

Hospital de la Santa Cruz y San Pablo; 🇪🇸 Barcelona, Spain