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

NCT01836211 | Terminated DMC

• 1 other identifier: IIBSP-DIA-2010-18
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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).

Conditions

Chest Pain; Acute Coronary Syndrome

Keywords

Chest pain; Acute coronary syndrome; Cardiac biomarkers; Computed coronary tomography angiography; Emergency department

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• All cause mortality

  1 month

• Myocardial infarction

  1 month

• Unstable angina

  1 month

• Heart Failure

  1 month

• Hospital admission

  1 month

Study Arms (2)

Fast strategy

EXPERIMENTAL

High sensitivity cardiac troponin T followed by computed coronary tomography angiography

Other: Fast strategy

Standard of care strategy

ACTIVE COMPARATOR

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

Other: Standard of care strategy

Interventions

Fast strategy OTHER

High sensitivity troponin T followed by computed coronary tomography angiography

Fast strategy

Standard of care strategy OTHER

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

Standard of care strategy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chest pain consistent with possible acute coronary syndrome.
• Age \> 18 years.
• Informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Santa Cruz y San Pablo

Barcelona, Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Chest Pain; Acute Coronary Syndrome; Emergencies

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2012
• First Posted: April 19, 2013
• Study Start: September 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 19, 2013

Record last verified: 2013-04

Locations

ES (1)