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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Walter Reed Army Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Todd C. Villines, Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier:
NCT01061398
First received: February 2, 2010
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: CT-FIRST: Cardiac Computed Tomography Versus Stress Imaging For Initial Risk STratification

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total number and per-patient rates of adverse cardiac events (cardiac death, myocardial infarction, unstable angina, coronary revascularization) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Total number and per-patient rates of subsequent outpatient + inpatient + emergency department encounters for the initial cardiac complaint [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in motivation for healthy behavioral change [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Change in subject anxiety, as assessed by the State and Trait Anxiety Inventory [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Change in subject depression [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Satisfaction with diagnostic evaluation for initial complaint. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: November 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061398

Locations
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
Investigators
Principal Investigator: Todd C. Villines, M.D. Walter Reed Army Medical Center
  More Information

No publications provided

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
Study First Received: February 2, 2010
Last Updated: June 27, 2012
Health Authority: United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:
cardiac ct
stress testing
coronary artery disease

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Chest Pain
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014