Completed

Usefulness of Coronary CTA for the Diagnosis of Acute Coronary Syndrome in the Emergency Room.

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What is being tested

computed coronary angiography

+ Exercise stress echocardiography

RadiationProcedure
Who is being recruted

Arterial Occlusive Diseases+19

+ Arteriosclerosis

+ Cardiovascular Diseases

Over 35 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: January 2010
See protocol details

Summary

Principal SponsorJosé Ortiz
Last updated: October 16, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2010

Actual date on which the first participant was enrolled.

Design and Aim: This is a prospective pilot study to evaluate the role of multidetector row computed tomography angiography (CTA) to rule out Acute Coronary Syndrome among patients presenting to the ER with chest pain complaints, non-diagnostic ECG and normal troponins and intermediate pre-test probability for significant CAD. Methods: Following the initial clinical evaluation and the results of initial ECG, blood test and X-ray, patients meeting the inclusion criteria will be randomized to undergo either a CTA scan or a Exercise Stress Echocardiogram to rule out significant coronary artery disease. CTA will be carried out in a 64 or 128 slice-CT Scanner (SIEMENS,Somaton Sensation 64 or 128-Flash Definition)following iv administration of iodinated contrast (bolus: 5cc x acquisition time (seg)+ 10 cc). Images will be interpreted by two experienced physicians (radiologist and cardiologist) Stress Echocardiography will be performed and interpreted by an experienced Echocardiographer (cardiologist). Clinical decision making: Patients with a positive or inconclusive test in each arm will be admitted to the hospital for treatment or further additional testing, while patients with negative results will be discharged from the ER. Safety issues: A phone call and chart review will be performed one month and 6 months follow-up to register the occurrence of any major adverse cardiac events, as well as new consultation for chest pain.

NCT01682096
Principal SponsorJosé Ortiz
Last updated: October 16, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 35 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesCoronary DiseaseHeart DiseasesInfarctionIschemiaNecrosisNeurologic ManifestationsPainPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesMyocardial IschemiaDisease AttributesChest PainCoronary Artery DiseaseDeathEmergenciesMyocardial InfarctionAcute Coronary Syndrome

Criteria

5 inclusion criteria required to participate
Absence of ECG changes suggestive of myocardial ischemia (ST-segment deviation > 1 mm or T Wave inversion > 4 mm in at least two contiguous leads)
Estimated pre-test probability of significant coronary artery disease more than 15%
Negative initial troponins I at admission ( < 0.05 ng/ml)
Patient is in Sinus Rhythm
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7 exclusion criteria prevent from participating
Any of the following:hemodynamic instability, persistent chest pain despite treatment, Systolic blood pressure < 100 mm Hg
Cardiac arrhythmia with rapid or irregular ventricular response
History of known coronary artery disease or prior myocardial revascularization
Inability to perform an exercise test
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Patients will undergo a MDCT as the initial diagnostic test to rule out Acute Coronary Syndrome

Group II

Active Comparator
Patients will undergo exercise stress echocardiography as the initial diagnostic test to rule out acute coronary syndrome.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Hospital Clinic Barcelona

Barcelona, SpainOpen Hospital Clinic Barcelona in Google Maps
CompletedOne Study Center