Clinical Trial: Coronary CT Angiography in Acute Chest Pain is a Cost Effective Risk Stratification Strategy
Study Status: Suspended
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Inclusion of Multi-Detector CT Angiography (MDCT) in Low to Intermediate Risk Chest Pain Patients Presenting to the Emergency Department; a Randomized Cost Analysis
Brief Summary: This study will evaluate the impact of adding coronary computed tomographic angiography (CTA) on health care costs for diagnosing patients with acute chest pain.
Detailed Summary:
Background and Significance
Standard-of-care risk-stratification algorithm (SOC):
In the past 20 years since Goldman et al4 described a clinical algorithm to predict MI in ED patients, the clinical ability to decrease the false-negative rate for myocardial events has not improved. Hence, the emergency physician (EP) is compelled to admit to the hospital the majority of patients who present with acute chest pain for further observation and investigation due to inconclusive evidence of ACS or MI during the index ED visit; false-negatives are still sent home with CAD; and false-positives are admitted without CAD; accounting for a significant consumption of resources every year in the US1.
The current state of the art for EPs includes clinical data, electrocardiograms (ECGs) and cardiac biomarkers5 (Fig. 1). The limitations of using the Goldman prediction rule and the ECG is that they are insensitive indicators of myocardial injury in patients with MI4-9. The sensitivity and specificity of cardiac biomarkers is proportional to the time from onset of chest pain. Cardiac troponin begins to rise within 3-4 hours after the onset of myocardial injury and may remain increased for up to 4-7 days for cTnI and 10-14 days for cTnT10. There is enthusiasm for myoglobin as an early marker; however, myoglobin is non-specific11-16 In ED based trials; cardiac biomarkers have performed well but have not changed the cost and admission rate (false-positives). In 1999, McCord et al9 published a single center prospective cohort study that examined point-of-care cardiac biomarkers during the first 90 minutes and if they could help to exclude AMI in the ED chest pain patient. The post-hoc analysis and resultant negative predictive value (NPV) was 98 to 99% at time 0 minutes, 90 minutes, and 3-hours w
Sponsor: University of Texas Southwestern Medical Center
Current Primary Outcome: Determine if the cumulative costs over 90-days of providing treatment services are reduced when adding coronary CTA to the standard-of-care (CTA + SOC) in patients with acute chest pain compared to SOC alone. [ Time Frame: 90-days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Determine if the rate of hospitalizations, nuclear perfusion scans and interventional cardiac catheterizations will be reduced by adding the coronary CTA to the SOC (CTA + SOC) compared to the SOC alone. [ Time Frame: 90-days ]
- Compare the rate of death, myocardial infarct (MI), acute coronary syndrome (ACS), and recidivism to the ED over 90-days when adding coronary CTA to the SOC (CTA + SOC) in ED patients with acute chest pain compared to the SOC alone group. [ Time Frame: 90-days ]
Original Secondary Outcome: Same as current
Information By: University of Texas Southwestern Medical Center
Dates:
Date Received: January 19, 2009
Date Started: October 2008
Date Completion:
Last Updated: January 20, 2009
Last Verified: January 2009
