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Clinical Trials/NCT01836211
NCT01836211TerminatedNot Applicable

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 Pau2 sites in 1 country101 target enrollmentStarted: September 1, 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
101
Locations
2
Primary Endpoint
All cause mortality, new myocardial infarction, new unstable angina, new heart failure, new hospital admission, new consult to the Emergency Department
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Secondary Outcomes

  • Heart Failure(1 month)
  • All cause mortality(1 month)
  • Myocardial infarction(1 month)
  • Unstable angina(1 month)
  • Hospital admission(1 month)

Investigators

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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