Pilot Safety Study of Coronary CTA for the Diagnosis of Acute Coronary Syndrome in the Emergency Room
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|ClinicalTrials.gov Identifier: NCT01682096|
Recruitment Status : Completed
First Posted : September 10, 2012
Last Update Posted : October 16, 2013
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 or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome Coronary Artery Disease Cardiac Death Myocardial Infarction||Radiation: computed coronary angiography Procedure: Exercise stress echocardiography||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Usefulness of Coronary CTA for the Diagnosis of Acute Coronary Syndrome in the Emergency Room.|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
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.
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
- Diagnosis of Acute Coronary Syndrome during admission or occurrence of Major Acute Cardiac Events after discharge [ Time Frame: 6 months ]Major adverse cardiac events include: All cause mortality, acute myocardial infarction, need for coronary revascularization
- Major adverse cardiac events on follow-up [ Time Frame: 6 months ]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 ]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.
- Time to clinical decision [ Time Frame: first 24 hs. ]Time from patient admission to the clinical decision (admission for further testing or discharge from the ER) between the two arms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682096
|Hospital Clinic Barcelona|
|Barcelona, Catalonia, Spain, 08036|
|Principal Investigator:||José T Ortiz-Perez, MD, PhD||Hospital Clinic of Barcelona|