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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Walter Reed Army Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Todd C. Villines, Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier:
NCT01061398
First received: February 2, 2010
Last updated: June 27, 2012
Last verified: June 2012

February 2, 2010
June 27, 2012
November 2007
December 2012   (final data collection date for primary outcome measure)
Rates of adverse cardiac events and resource utilization (rates of additional diagnostic tests that are performed for the initial complaint of angina/angina equivalent and clinical outpatient/inpatient/ED encounters for the initial cardiac complaint) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01061398 on ClinicalTrials.gov Archive Site
  • Total number and per-patient rates of adverse cardiac events (cardiac death, myocardial infarction, unstable angina, coronary revascularization) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Total number and per-patient rates of subsequent cardiac diagnostic tests performed (stress tests, cardiac catheterizations, other tests) for the initial complaint of angina/angina equivalent [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Total number and per-patient rates of subsequent outpatient + inpatient + emergency department encounters for the initial cardiac complaint [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Avoidance of unnecessary cardiac catheterizations. An unnecessary cardiac catheterization is defined as a catheterization showing non-obstructive coronary disease and no cause for the symptoms. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Change in motivation for healthy behavioral change [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Change in subject anxiety, as assessed by the State and Trait Anxiety Inventory [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Change in subject depression [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Satisfaction with diagnostic evaluation for initial complaint. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
CT-FIRST: Cardiac Computed Tomography Versus Stress Imaging For Initial Risk STratification
CT-FIRST: Cardiac Computed Tomography Versus Stress Imaging For Initial Risk STratification

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Coronary Artery Disease
  • Chest Pain
  • Coronary Atherosclerosis
  • Stress Testing
  • 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)
  • Experimental: Cardiac CT Arm
    Patients referred for stress imaging due to complaints consistent with possible angina, randomized to receive an additional cardiac CT scan.
    Intervention: Procedure: Cardiac CT Angiography
  • Active Comparator: No CT Arm
    Patients with symptoms consistent with possible angina, randomized to receive the type of stress imaging test ordered by their physician.
    Intervention: Procedure: Stress Imaging Test (Stress Myocardial Perfusion Study or Stress Echocardiogram)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
240
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age between 18 and 70 years of age at time of enrollment.
  • Chest pain or anginal equivalent symptoms possibly suggestive of symptomatic coronary artery disease
  • Low-intermediate risk (<75% pretest probability) for symptomatic coronary artery disease on basis of age, sex, and quality of reported symptom as classified by the Diamond and Forrester scheme.
  • Referred for a either a stress echocardiogram or a nuclear stress perfusion study.
  • Ability to provide informed consent.

Exclusion Criteria:

  • Presence of known pre-existing coronary artery disease (known prior myocardial infarction, ECG evidence of prior infarction, prior angiographic evidence of significant coronary artery disease, history of prior coronary revascularization).
  • Previous outpatient or inpatient evaluation for coronary artery disease to include exercise treadmill testing, stress echocardiography or nuclear myocardial perfusion studies within the last 24 months.
  • Presence of signs or symptoms that are clearly compatible with non-cardiac chest pain, including musculoskeletal, gastrointestinal or neuropathic causes.
  • Renal insufficiency (creatinine >1.5mg/dl) or renal failure requiring dialysis.
  • Baseline heart rate > 100bpm, atrial fibrillation or other markedly irregular rhythm (frequent ectopy, multifocal atrial tachycardia) on baseline ECG.
  • Pregnancy or unknown pregnancy status.
  • Known allergy to iodinated contrast.
  • Inability to tolerate beta-blocking drugs, including patients with reactive airways disease requiring maintenance inhaled bronchodilators or steroids, complete heart block or second-degree atrioventricular block.
  • Patients with hyperthyroidism including Grave's disease and toxic multinodular goiter
  • Computed tomography imaging or iodinated contrast administration over 50 ml, within the past 48 hours.
  • Inability to withhold ingestion of metformin or commonly used erectile dysfunction medications (Viagra, Cialis, Levitra) for 48 hours prior to and following MSCT scan.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01061398
WU#08-12032
Yes
Todd C. Villines, Walter Reed National Military Medical Center
Walter Reed Army Medical Center
Not Provided
Principal Investigator: Todd C. Villines, M.D. Walter Reed Army Medical Center
Walter Reed Army Medical Center
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP