High-Sensitivity Troponin T and Coronary Computed Tomography Angiography for Rapid Diagnosis of Emergency Chest Pain: a Randomized Controlled Study

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 site in 1 country101 target enrollmentSeptember 2011

ConditionsChest Pain Acute Coronary Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chest Pain
Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Enrollment: 101
Locations: 1
Primary Endpoint: All cause mortality, new myocardial infarction, new unstable angina, new heart failure, new hospital admission, new consult to the Emergency Department
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

September 2011

End Date

June 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

All cause mortality, new myocardial infarction, new unstable angina, new heart failure, new hospital admission, new consult to the Emergency Department

Time Frame: 1 month after index event

Composite end-point.