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

• 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

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