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The Addition of Cardiac CT to Exercise Treadmill Testing in the Evaluation of Angina (CT-EXTRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00491218
Recruitment Status : Unknown
Verified June 2007 by Walter Reed Army Medical Center.
Recruitment status was:  Recruiting
First Posted : June 26, 2007
Last Update Posted : June 26, 2007
Information provided by:
Walter Reed Army Medical Center

Brief Summary:

The current outpatient evaluation for angina 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 moderate sensitivity and specificity, often resulting in further cardiac resource utilization for patient risk stratification and reassurance. With the advent of coronary multislice computed tomography (MSCT) angiography, coronary artery anatomy can now be evaluated noninvasively. Despite its impressive performance characteristics, the role of coronary MSCT angiography in the outpatient evaluation of angina remains undefined.

CT-EXTRA compares the impact on patient safety and downstream resource utilization of a novel initial diagnostic strategy employing the addition of coronary MSCT angiography to exercise treadmill testing with a standard diagnostic strategy of exercise treadmill testing for the ambulatory evaluation of low-intermediate risk patients with possible angina. The study is a single center, prospective, non-blinded, randomized clinical trial. Men and women, age 18-70, with a low to intermediate pretest probability of coronary artery disease who are referred for an exercise treadmill test for angina are eligible. Subjects are randomized either to an initial diagnostic strategy of exercise treadmill testing or exercise treadmill testing with coronary MSCT angiography. Subsequent diagnostic testing and treatment are the discretion of the referring physician. Subjects will be clinically followed for 24 months.

The clinical impact on patient safety and downstream clinical resource utilization of this novel diagnostic strategy in which both coronary artery anatomy and function are initially evaluated will be determined. The primary outcome is a composite endpoint consisting of freedom from adverse cardiac events, further cardiac diagnostic testing, and future cardiac clinical encounters. Secondary outcomes include the impact on the indiscriminate use of coronary angiography, subject anxiety, depression, motivation for healthy behavioral change, and satisfaction with diagnostic evaluation and use of antiplatelet and antilipid therapy. Lastly, the cost effectiveness of the routine addition of coronary MSCT angiography in the outpatient evaluation of possible angina will be determined.

Condition or disease

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Study Type : Observational
Observational Model: Natural History
Time Perspective: Prospective
Official Title: The Addition of Cardiac Computed Tomography to Exercise Treadmill Testing in the Evaluation of Angina
Study Start Date : June 2007

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  1. Chest pain or anginal equivalent symptoms possibly suggestive of symptomatic coronary artery disease.
  2. 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 scheme6
  3. Referred to Walter Reed Cardiology clinic for an exercise treadmill test as the initial diagnostic test of choice
  4. Age equal to or greater than 18 years and less than 70 years
  5. Ability to provide informed consent

Exclusion Criteria:

  1. Abnormal baseline electrographic changes that would preclude proper diagnosis of ischemia including preexcitation (Wolff-Parkinson-White) syndrome, a paced ventricular rhythm, more than 1 mm of ST depression at rest, complete left bundle branch block, or criteria for left ventricular hypertrophy, even if they have less than 1 mm of baseline ST depression
  2. Presence of known pre-existing coronary artery disease (known prior myocardial infarction, EKG evidence of prior infarction, prior angiographic evidence of significant coronary artery disease, history of prior coronary revascularization).
  3. Previous outpatient or inpatient evaluation for coronary artery disease to include exercise treadmill testing, stress echocardiography or nuclear myocardial perfusion studies within the last three years.
  4. Presence of signs or symptoms that are clearly compatible with non-cardiac chest pain, including musculoskeletal, gastrointestinal or neuropathic causes.
  5. Renal insufficiency (creatinine >1.5mg/dl) or renal failure requiring dialysis.
  6. Baseline heart rate > 100bpm, atrial fibrillation or other markedly irregular rhythm (frequent ectopy, multifocal atrial tachycardia) on baseline ECG.
  7. Pregnancy or unknown pregnancy status.
  8. Known allergy to iodinated contrast.
  9. 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.
  10. Patients with hyperthyroidism including Grave's disease and toxic multinodular goiter
  11. Computed tomography imaging, or iodinated contrast administration over 50 ml, within the past 48 hours.
  12. Unwillingness to withhold ingestion of metformin or commonly used erectile dysfunction medications (Viagra, Cialis, Levitra) for 48 hours prior to MSCT scan.
  13. Previous history of radiation therapy to the thorax.

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 identifier (NCT number): NCT00491218

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Contact: Patrick J Devine, MD 2027829855
Contact: Allen J Taylor, MD 2027822887

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United States, District of Columbia
Walter Reed Army Medical Center Cardiology Service Recruiting
Washington, District of Columbia, United States, 20307
Principal Investigator: Patrick J Devine, MD         
Sponsors and Collaborators
Walter Reed Army Medical Center
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Principal Investigator: Patrick J Devine, MD WRAMC Cardiology
Layout table for additonal information Identifier: NCT00491218    
Other Study ID Numbers: 07-12030
First Posted: June 26, 2007    Key Record Dates
Last Update Posted: June 26, 2007
Last Verified: June 2007
Keywords provided by Walter Reed Army Medical Center:
impact of cardiac computed tomography on outpatient angina evaluation
downstream resource utilization
Additional relevant MeSH terms:
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Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Neurologic Manifestations