<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01682096</url>
  </required_header>
  <id_info>
    <org_study_id>PI09/90513</org_study_id>
    <nct_id>NCT01682096</nct_id>
  </id_info>
  <brief_title>Pilot Safety Study of Coronary CTA for the Diagnosis of Acute Coronary Syndrome in the Emergency Room</brief_title>
  <official_title>Usefulness of Coronary CTA for the Diagnosis of Acute Coronary Syndrome in the Emergency Room.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>José Ortiz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto de Salud Carlos III</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Clinic of Barcelona</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Diagnosis of acute coronary syndrome in patients presenting with acute chest pain is&#xD;
      problematic when both, electrocardiogram and serum troponins are normal. Multidetector row&#xD;
      computed tomography angiography (CTA) allows direct and rapid non-invasive visualization of&#xD;
      coronary artery disease.&#xD;
&#xD;
      The investigator's aim is to assess the diagnostic accuracy and safety of a novel diagnostic&#xD;
      strategy based on MDCT as compared to a strategy using stress echocardiography in the workup&#xD;
      of patient with chest pain, normal electrocardiogram, normal troponins and suspected coronary&#xD;
      artery disease. Additionally, the cost associated with both strategies will be compared.&#xD;
&#xD;
      Methods. A total of 150 patients with acute chest pain coming to the emergency room with&#xD;
      intermediate probability of significant coronary artery disease, normal ECG and troponins&#xD;
      will be prospectively randomized to MDCT or stress echocardiography with exercise. Patients&#xD;
      showing coronary stenosis &gt;50% at MDCT or abnormal stress echocardiography or inconclusive&#xD;
      results will be admitted for further study. The primary endpoint of the study is the&#xD;
      detection of an acute coronary syndrome, defined as typical or atypical angina with&#xD;
      documented significant coronary artery disease (&gt;50% stenosis) on invasive coronariography, a&#xD;
      positive stress test or the occurrence of cardiac death, myocardial infarction or need for&#xD;
      revascularization during 6 month follow-up. All MDCT angiograms and echocardiograms will be&#xD;
      evaluated by an experienced radiologist and cardiologist.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design and Aim: This is a prospective pilot study to evaluate the role of multidetector row&#xD;
      computed tomography angiography (CTA) to rule out Acute Coronary Syndrome among patients&#xD;
      presenting to the ER with chest pain complaints, non-diagnostic ECG and normal troponins and&#xD;
      intermediate pre-test probability for significant CAD.&#xD;
&#xD;
      Methods: Following the initial clinical evaluation and the results of initial ECG, blood test&#xD;
      and X-ray, patients meeting the inclusion criteria will be randomized to undergo either a CTA&#xD;
      scan or a Exercise Stress Echocardiogram to rule out significant coronary artery disease.&#xD;
&#xD;
      CTA will be carried out in a 64 or 128 slice-CT Scanner (SIEMENS,Somaton Sensation 64 or&#xD;
      128-Flash Definition)following iv administration of iodinated contrast (bolus: 5cc x&#xD;
      acquisition time (seg)+ 10 cc). Images will be interpreted by two experienced physicians&#xD;
      (radiologist and cardiologist)&#xD;
&#xD;
      Stress Echocardiography will be performed and interpreted by an experienced Echocardiographer&#xD;
      (cardiologist).&#xD;
&#xD;
      Clinical decision making: Patients with a positive or inconclusive test in each arm will be&#xD;
      admitted to the hospital for treatment or further additional testing, while patients with&#xD;
      negative results will be discharged from the ER.&#xD;
&#xD;
      Safety issues: A phone call and chart review will be performed one month and 6 months&#xD;
      follow-up to register the occurrence of any major adverse cardiac events, as well as new&#xD;
      consultation for chest pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnosis of Acute Coronary Syndrome during admission or occurrence of Major Acute Cardiac Events after discharge</measure>
    <time_frame>6 months</time_frame>
    <description>Major adverse cardiac events include: All cause mortality, acute myocardial infarction, need for coronary revascularization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiac events on follow-up</measure>
    <time_frame>6 months</time_frame>
    <description>Safety endpoint: occurrence of MACE among discharged patients in whom acute coronary syndrome has been ruled out according to the test results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Costs during admission (Euros)</measure>
    <time_frame>6 months</time_frame>
    <description>The total costs derivated from the admission between the two arms of the study will be compared. Results will be reported in Euros, and will include the costs of the CTA or Stress echocardiography as well as additional tests performed during admission.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Time to clinical decision</measure>
    <time_frame>first 24 hs.</time_frame>
    <description>Time from patient admission to the clinical decision (admission for further testing or discharge from the ER) between the two arms.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Coronary Artery Disease</condition>
  <condition>Cardiac Death</condition>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Computed coronary angiography (CTA)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will undergo a MDCT as the initial diagnostic test to rule out Acute Coronary Syndrome</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise stress echocardiography</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will undergo exercise stress echocardiography as the initial diagnostic test to rule out acute coronary syndrome.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>computed coronary angiography</intervention_name>
    <description>Patients will be pre-medicated with atenolol 50 mg 1h prior to the scan.</description>
    <arm_group_label>Computed coronary angiography (CTA)</arm_group_label>
    <other_name>coronary cta</other_name>
    <other_name>SIEMENS 64/128 slice CT scanner</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Exercise stress echocardiography</intervention_name>
    <description>Limited by symptoms</description>
    <arm_group_label>Exercise stress echocardiography</arm_group_label>
    <other_name>Treadmil exercise stress echocardiography</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is in Sinus Rhythm&#xD;
&#xD;
          -  Typical or atypical chest pain lasting more than 5 min in the last 24 hs.&#xD;
&#xD;
          -  Estimated pre-test probability of significant coronary artery disease more than 15%.&#xD;
&#xD;
          -  Absence of ECG changes suggestive of myocardial ischemia (ST-segment deviation &gt;1 mm&#xD;
             or T Wave inversion &gt; 4 mm in at least two contiguous leads).&#xD;
&#xD;
          -  Negative initial troponins I at admission (&lt;0.05 ng/ml)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy to iodinated contrast.&#xD;
&#xD;
          -  Known renal insufficiency or Creatinine &gt;1.5 mg/dl at admission.&#xD;
&#xD;
          -  History of known coronary artery disease or prior myocardial revascularization&#xD;
&#xD;
          -  Any of the following:hemodynamic instability, persistent chest pain despite treatment,&#xD;
             Systolic blood pressure &lt;100 mm Hg.&#xD;
&#xD;
          -  Cardiac arrhythmia with rapid or irregular ventricular response.&#xD;
&#xD;
          -  Inability to perform an exercise test.&#xD;
&#xD;
          -  Patient is incapable of providing informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>José T Ortiz-Perez, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clinic of Barcelona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Clinic Barcelona</name>
      <address>
        <city>Barcelona</city>
        <state>Catalonia</state>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2013</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>October 15, 2013</last_update_submitted>
  <last_update_submitted_qc>October 15, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 16, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Clinic of Barcelona</investigator_affiliation>
    <investigator_full_name>José Ortiz</investigator_full_name>
    <investigator_title>MD, PhD,</investigator_title>
  </responsible_party>
  <keyword>Chest pain</keyword>
  <keyword>Emergency room</keyword>
  <keyword>Acute coronary syndrome</keyword>
  <keyword>Computed tomography coronary angiography</keyword>
  <keyword>Stress echocardiography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Death</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01682096
org study id: PI09/90513
nct id: NCT01682096
lead sponsor: 
collaborator: 
has dmc: No
The Diagnosis of acute coronary syndrome in patients presenting with acute chest pain is
      problematic when both, electrocardiogram and serum troponins are normal. Multidetector row
      computed tomography angiography (CTA) allows direct and rapid non-invasive visualization of
      coronary artery disease.

      The investigator's aim is to assess the diagnostic accuracy and safety of a novel diagnostic
      strategy based on MDCT as compared to a strategy using stress echocardiography in the workup
      of patient with chest pain, normal electrocardiogram, normal troponins and suspected coronary
      artery disease. Additionally, the cost associated with both strategies will be compared.

      Methods. A total of 150 patients with acute chest pain coming to the emergency room with
      intermediate probability of significant coronary artery disease, normal ECG and troponins
      will be prospectively randomized to MDCT or stress echocardiography with exercise. Patients
      showing coronary stenosis >50% at MDCT or abnormal stress echocardiography or inconclusive
      results will be admitted for further study. The primary endpoint of the study is the
      detection of an acute coronary syndrome, defined as typical or atypical angina with
      documented significant coronary artery disease (>50% stenosis) on invasive coronariography, a
      positive stress test or the occurrence of cardiac death, myocardial infarction or need for
      revascularization during 6 month follow-up. All MDCT angiograms and echocardiograms will be
      evaluated by an experienced radiologist and cardiologist.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnosis of Acute Coronary Syndrome during admission or occurrence of Major Acute Cardiac Events after discharge
time frame: 6 months
description: Major adverse cardiac events include: All cause mortality, acute myocardial infarction, need for coronary revascularization
measure: Major adverse cardiac events on follow-up
time frame: 6 months
description: Safety endpoint: occurrence of MACE among discharged patients in whom acute coronary syndrome has been ruled out according to the test results
measure: Costs during admission (Euros)
time frame: 6 months
description: The total costs derivated from the admission between the two arms of the study will be compared. Results will be reported in Euros, and will include the costs of the CTA or Stress echocardiography as well as additional tests performed during admission.
measure: Time to clinical decision
time frame: first 24 hs.
description: Time from patient admission to the clinical decision (admission for further testing or discharge from the ER) between the two arms.
arm group label: Computed coronary angiography (CTA)
arm group type: Active Comparator
description: Patients will undergo a MDCT as the initial diagnostic test to rule out Acute Coronary Syndrome
arm group label: Exercise stress echocardiography
arm group type: Active Comparator
description: Patients will undergo exercise stress echocardiography as the initial diagnostic test to rule out acute coronary syndrome.
intervention type: Radiation
intervention name: computed coronary angiography
description: Patients will be pre-medicated with atenolol 50 mg 1h prior to the scan.
arm group label: Computed coronary angiography (CTA)
other name: coronary cta
other name: SIEMENS 64/128 slice CT scanner
intervention type: Procedure
intervention name: Exercise stress echocardiography
description: Limited by symptoms
arm group label: Exercise stress echocardiography
other name: Treadmil exercise stress echocardiography
criteria: 
gender: All
minimum age: 35 Years
maximum age: N/A
healthy volunteers: No
last name: José T Ortiz-Perez, MD, PhD
role: Principal Investigator
affiliation: Hospital Clinic of Barcelona
facility: 
country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital Clinic of Barcelona
investigator full name: José Ortiz
investigator title: MD, PhD,
mesh term: Coronary Artery Disease
mesh term: Myocardial Infarction
mesh term: Acute Coronary Syndrome
mesh term: Syndrome
mesh term: Infarction
mesh term: Emergencies
mesh term: Death