Recruiting

Cardiac CT

Sponsor:

Walter Reed Army Medical Center

Code:

NCT00491218

Conditions

Angina

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Angina

Study ID

NCT00491218

Start date

Jun, 2007

Status verified date

Jun, 2007

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Interventions and Outcome Measures

Central Contacts and Locations

Central contacts

Patrick J Devine, MD

2027829855patrick.devine@na.amedd.army.mil

Allen J Taylor, MD

2027822887allen.taylor@na.amedd.army.mil

Locations

Walter Reed Army Medical Center Cardiology Service

Recruiting

Washington, District of Columbia, United States, 20307

Principal Investigator:

Patrick J Devine, MD

More Information

Sponsor

Walter Reed Army Medical Center

Last update posted

Jun 26, 2007

Last verified

Jun, 2007

Keywords

  • impact of cardiac computed tomography on outpatient angina evaluation
  • downstream resource utilization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed Army Medical Center on 2007-06-26.