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

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ClinicalTrials.gov Identifier: NCT01061398
Recruitment Status : Unknown
Verified June 2012 by Todd C. Villines, Walter Reed National Military Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : February 3, 2010
Last Update Posted : June 28, 2012
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Coronary Artery Disease Chest Pain Coronary Atherosclerosis Stress Testing Procedure: Cardiac CT Angiography Procedure: Stress Imaging Test (Stress Myocardial Perfusion Study or Stress Echocardiogram)

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: CT-FIRST: Cardiac Computed Tomography Versus Stress Imaging For Initial Risk STratification
Study Start Date : November 2007
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Cardiac CT Arm
Patients referred for stress imaging due to complaints consistent with possible angina, randomized to receive an additional cardiac CT scan.
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
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.
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)

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Total number and per-patient rates of adverse cardiac events (cardiac death, myocardial infarction, unstable angina, coronary revascularization) [ Time Frame: 24 months ]
  2. 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 ]
  3. Total number and per-patient rates of subsequent outpatient + inpatient + emergency department encounters for the initial cardiac complaint [ Time Frame: 24 months ]
  4. 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 ]
  5. Change in motivation for healthy behavioral change [ Time Frame: 24 months ]
  6. Change in subject anxiety, as assessed by the State and Trait Anxiety Inventory [ Time Frame: 24 months ]
  7. Change in subject depression [ Time Frame: 24 months ]
  8. Satisfaction with diagnostic evaluation for initial complaint. [ Time Frame: 24 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061398

United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
Sponsors and Collaborators
Walter Reed Army Medical Center
Principal Investigator: Todd C. Villines, M.D. Walter Reed Army Medical Center
More Information

Responsible Party: Todd C. Villines, Director, Cardiovascular Research, Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier: NCT01061398     History of Changes
Other Study ID Numbers: WU#08-12032
First Posted: February 3, 2010    Key Record Dates
Last Update Posted: June 28, 2012
Last Verified: June 2012

Keywords provided by Todd C. Villines, Walter Reed National Military Medical Center:
cardiac ct
stress testing
coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Chest Pain
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms