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

NCT01682096 | Completed

• 1 other identifier: PI09/90513
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Coronary Syndrome; Coronary Artery Disease; Cardiac Death; Myocardial Infarction

Keywords

Chest pain; Emergency room; Acute coronary syndrome; Computed tomography coronary angiography; Stress echocardiography

Outcome Measures

Primary Outcomes (1)

• Diagnosis of Acute Coronary Syndrome during admission or occurrence of Major Acute Cardiac Events after discharge

  Major adverse cardiac events include: All cause mortality, acute myocardial infarction, need for coronary revascularization

  6 months

Secondary Outcomes (2)

• Major adverse cardiac events on follow-up

  6 months

• Costs during admission (Euros)

  6 months

Other Outcomes (1)

• Time to clinical decision

  first 24 hs.

Study Arms (2)

Computed coronary angiography (CTA)

ACTIVE COMPARATOR

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

Radiation: computed coronary angiography

Exercise stress echocardiography

ACTIVE COMPARATOR

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

Procedure: Exercise stress echocardiography

Interventions

computed coronary angiography RADIATION

Patients will be pre-medicated with atenolol 50 mg 1h prior to the scan.

Also known as: coronary cta, SIEMENS 64/128 slice CT scanner

Computed coronary angiography (CTA)

Exercise stress echocardiography PROCEDURE

Limited by symptoms

Also known as: Treadmil exercise stress echocardiography

Exercise stress echocardiography

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• José Ortiz: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital Clinic Barcelona

Barcelona, Catalonia, 08036, Spain

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Coronary Artery Disease; Death; Myocardial Infarction; Chest Pain; Emergencies

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Necrosis; Pain; Neurologic Manifestations; Signs and Symptoms; Disease Attributes

Study Officials

• José T Ortiz-Perez, MD, PhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD,

Study Record Dates

• First Submitted: September 6, 2012
• First Posted: September 10, 2012
• Study Start: January 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

ES (1)