Pilot Safety Study of Coronary CTA for the Diagnosis of Acute Coronary Syndrome in the Emergency Room
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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. |
- 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
- 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.
- 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.
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 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:
|
|
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 |
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| Contact: José T Ortiz-Pérez, MD, PhD | +034 93 2275505 | jtortiz@clinic.ub.es |
| Spain | |
| Hospital Clinic Barcelona | Recruiting |
| Barcelona, Catalonia, Spain, 08036 | |
| Contact: José T Ortiz-Perez, MD, PhD +034 932275505 jtortiz@clinic.ub.es | |
| Contact: Xavier Bosch, MD, PhD +034 932275400 ext 2680 xbosch@clinic.ub.es | |
| Principal Investigator: José T Ortiz-Pérez, MD, PhD | |
| Sub-Investigator: Xavier Bosch, MD, PhD | |
| Sub-Investigator: Carlos Paré, MD, PhD | |
| Sub-Investigator: Teresa M De Caralt, MD, PhD | |
| Sub-Investigator: Marta Sitges, MD, PhD | |
| Sub-Investigator: Rosario J Perea, MD, PhD | |
| Sub-Investigator: Monica Masotti, MD, PhD | |
| Principal Investigator: | José T Ortiz-Perez, MD, PhD | Hospital Clinic 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: | September 10, 2012 |
| 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 May 23, 2013