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

Acute Coronary Syndrome Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01836211
• Other study ID #: IIBSP-DIA-2010-18
• Status: Terminated
• Phase: N/A
• First received: November 23, 2012
• Last updated: April 11, 2013
• Start date: September 2011
• Est. completion date: June 2013

Study information

• Verified date: April 2013
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 101
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain
• Emergencies

Intervention

Other:
• Fast strategy
High sensitivity troponin T followed by computed coronary tomography angiography
• Standard of care strategy
Standard of care strategy: serial electrocardiograms and cardiac biomarkers followed by stress/rest cardiac imaging study

Locations

Country	Name	City	State
Spain	Hospital de la Santa Cruz y San Pablo	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality, new myocardial infarction, new unstable angina, new heart failure, new hospital admission, new consult to the Emergency Department	Composite end-point.	1 month after index event	Yes
Secondary	All cause mortality		1 month	Yes
Secondary	Myocardial infarction		1 month	Yes
Secondary	Unstable angina		1 month	Yes
Secondary	Heart Failure		1 month	Yes
Secondary	Hospital admission	New cardiovascular hospital admission	1 month	Yes