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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Walter Reed Army Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00491218
First received: June 22, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose

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
Angina

Study Type: Observational
Study Design: Allocation: Random Sample
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: The Addition of Cardiac Computed Tomography to Exercise Treadmill Testing in the Evaluation of Angina

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Walter Reed Army Medical Center:

Study Start Date: June 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00491218

Contacts
Contact: Patrick J Devine, MD 2027829855 patrick.devine@na.amedd.army.mil
Contact: Allen J Taylor, MD 2027822887 allen.taylor@na.amedd.army.mil

Locations
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
Investigators
Principal Investigator: Patrick J Devine, MD WRAMC Cardiology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00491218     History of Changes
Other Study ID Numbers: 07-12030
Study First Received: June 22, 2007
Last Updated: June 22, 2007
Health Authority: United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:
impact of cardiac computed tomography on outpatient angina evaluation
downstream resource utilization

Additional relevant MeSH terms:
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013