NCT01061398

CT-FIRST: Cardiac Computed Tomography Versus Stress Imaging For Initial Risk STratification

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Walter Reed Army Medical Center · Federal
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

In patients with chest pain or shortness of breath who are referred for stress imaging tests (either stress echocardiography or stress nuclear testing), the investigators seek to compare impact of using cardiac CT scans of the heart arteries to the stress test that their doctors ordered.

Detailed description

The current evaluation for chest pain in low and intermediate risk patients typically starts with a functional assessment for coronary ischemia. Exercise treadmill testing is often selected as the initial diagnostic modality for coronary artery function. However, exercise treadmill testing is limited by its modest sensitivity and specificity, often resulting in further cardiac resource utilization for patient risk stratification and reassurance. Additionally, many patients with chest pain are not candidates for regular stress testing due to an abnormal baseline electrocardiogram or inability to exercise. Therefore, exercise or pharmacologic stress imaging is considered the standard of care for the evaluation of coronary artery function in a large percentage of patients with chest pain. However, each of the currently available stress imaging tests has well-documented limitations, resulting in a sizeable number of false negative and false positive studies. With the advent of coronary Multislice Computed Tomography (MSCT) angiography, coronary artery anatomy can now be accurately evaluated noninvasively. Despite its impressive performance characteristics, the role of coronary MSCT angiography in the evaluation of angina remains undefined. Furthermore, studies comparing MSCT to stress imaging are lacking. CT-FIRST compares the impact on downstream resource utilization and patient outcomes of an initial diagnostic strategy employing the addition of coronary MSCT angiography to stress imaging (exercise and pharmacologic stress echo and nuclear perfusion testing) with a standard-of-care diagnostic strategy of stress imaging for the evaluation of low-intermediate risk patients with possible angina. The study is a single center, prospective, non-blinded, randomized clinical trial.

Conditions

• Coronary Artery Disease
• Chest Pain
• Coronary Atherosclerosis
• Stress Testing

Interventions

Type	Name	Description
PROCEDURE	Cardiac CT Angiography	Patients randomized to CT Arm will undergo 64-slice cardiac CT angiography (single scan) in addition to the stress imaging test ordered by their physician
PROCEDURE	Stress Imaging Test (Stress Myocardial Perfusion Study or Stress Echocardiogram)	Stress imaging test as ordered by the subjects provider without option for cardiac CT angiography (no CT arm)

Timeline

• Start date: 2007-11-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-02-03
• Last updated: 2012-06-28

Locations

1 site across 1 country: United States