Pilot Safety Study of Coronary CTA for the Diagnosis of Acute Coronary Syndrome in the Emergency Room

This study has been completed.
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
José Ortiz, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01682096
First received: September 6, 2012
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Acute Coronary Syndrome
Coronary Artery Disease
Cardiac Death
Myocardial Infarction
Radiation: computed coronary angiography
Procedure: Exercise stress echocardiography

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Usefulness of Coronary CTA for the Diagnosis of Acute Coronary Syndrome in the Emergency Room.

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Diagnosis of Acute Coronary Syndrome during admission or occurrence of Major Acute Cardiac Events after discharge [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Major adverse cardiac events include: All cause mortality, acute myocardial infarction, need for coronary revascularization


Secondary Outcome Measures:
  • Major adverse cardiac events on follow-up [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Safety endpoint: occurrence of MACE among discharged patients in whom acute coronary syndrome has been ruled out according to the test results

  • Costs during admission (Euros) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Time to clinical decision [ Time Frame: first 24 hs. ] [ Designated as safety issue: No ]
    Time from patient admission to the clinical decision (admission for further testing or discharge from the ER) between the two arms.


Enrollment: 150
Study Start Date: January 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Computed coronary angiography (CTA)
Patients will undergo a MDCT as the initial diagnostic test to rule out Acute Coronary Syndrome
Radiation: computed coronary angiography
Patients will be pre-medicated with atenolol 50 mg 1h prior to the scan.
Other Names:
  • coronary cta
  • SIEMENS 64/128 slice CT scanner
Active Comparator: Exercise stress echocardiography
Patients will undergo exercise stress echocardiography as the initial diagnostic test to rule out acute coronary syndrome.
Procedure: Exercise stress echocardiography
Limited by symptoms
Other Name: Treadmil exercise stress echocardiography

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is in Sinus Rhythm
  • Typical or atypical chest pain lasting more than 5 min in the last 24 hs.
  • Estimated pre-test probability of significant coronary artery disease more than 15%.
  • 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).
  • Negative initial troponins I at admission (<0.05 ng/ml)

Exclusion Criteria:

  • Known allergy to iodinated contrast.
  • Known renal insufficiency or Creatinine >1.5 mg/dl at admission.
  • History of known coronary artery disease or prior myocardial revascularization
  • 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.
  • Inability to perform an exercise test.
  • Patient is incapable of providing informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01682096

Locations
Spain
Hospital Clinic Barcelona
Barcelona, Catalonia, Spain, 08036
Sponsors and Collaborators
José Ortiz
Instituto de Salud Carlos III
Investigators
Principal Investigator: José T Ortiz-Perez, MD, PhD Hospital Clinic of Barcelona
  More Information

No publications provided

Responsible Party: José Ortiz, MD, PhD,, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01682096     History of Changes
Other Study ID Numbers: PI09/90513
Study First Received: September 6, 2012
Last Updated: October 15, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Clinic of Barcelona:
Chest pain
Emergency room
Acute coronary syndrome
Computed tomography coronary angiography
Stress echocardiography

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Emergencies
Infarction
Myocardial Infarction
Death
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Disease Attributes
Pathologic Processes
Ischemia
Necrosis
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014