The Addition of Cardiac CT to Exercise Treadmill Testing in the Evaluation of Angina

NCT00491218 | Unknown

• 1 other identifier: 07-12030
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 scheme6
• Referred to Walter Reed Cardiology clinic for an exercise treadmill test as the initial diagnostic test of choice
• Age equal to or greater than 18 years and less than 70 years
• Ability to provide informed consent

You may not qualify if:

• 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
• 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).
• 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.
• 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.
• Unwillingness to withhold ingestion of metformin or commonly used erectile dysfunction medications (Viagra, Cialis, Levitra) for 48 hours prior to MSCT scan.
• Previous history of radiation therapy to the thorax.

Sponsors & Collaborators

• Walter Reed Army Medical Center: lead

Study Sites (1)

Walter Reed Army Medical Center Cardiology Service

Washington D.C., District of Columbia, 20307, United States

RECRUITING

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick J Devine, MD

  WRAMC Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick J Devine, MD

CONTACT

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

Allen J Taylor, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: NATURAL HISTORY
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED

Study Record Dates

• First Submitted: June 22, 2007
• First Posted: June 26, 2007
• Study Start: June 1, 2007
• Last Updated: June 26, 2007

Record last verified: 2007-06

Locations

US (1)