Back to resultsCT-FIRST: Cardiac Computed Tomography Versus Stress Imaging For Initial Risk STratification (CT-FIRST)
Primary Purpose
Coronary Artery Disease, Chest Pain, Coronary Atherosclerosis
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiac CT Angiography
Stress Imaging Test (Stress Myocardial Perfusion Study or Stress Echocardiogram)
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring cardiac ct, stress testing, coronary artery disease
Eligibility 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.
Sites / Locations
- Walter Reed Army Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cardiac CT Arm
No CT Arm
Arm Description
Patients referred for stress imaging due to complaints consistent with possible angina, randomized to receive an additional cardiac CT scan.
Patients with symptoms consistent with possible angina, randomized to receive the type of stress imaging test ordered by their physician.
Outcomes
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)
Secondary Outcome Measures
Total number and per-patient rates of adverse cardiac events (cardiac death, myocardial infarction, unstable angina, coronary revascularization)
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
Total number and per-patient rates of subsequent outpatient + inpatient + emergency department encounters for the initial cardiac complaint
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.
Change in motivation for healthy behavioral change
Change in subject anxiety, as assessed by the State and Trait Anxiety Inventory
Change in subject depression
Satisfaction with diagnostic evaluation for initial complaint.
Full Information
NCT ID
NCT01061398
First Posted
February 2, 2010
Last Updated
June 27, 2012
Sponsor
Walter Reed Army Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01061398
Brief Title
CT-FIRST: Cardiac Computed Tomography Versus Stress Imaging For Initial Risk STratification
Acronym
CT-FIRST
Official Title
CT-FIRST: Cardiac Computed Tomography Versus Stress Imaging For Initial Risk STratification
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Walter Reed Army Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Chest Pain, Coronary Atherosclerosis, Stress Testing
Keywords
cardiac ct, stress testing, coronary artery disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardiac CT Arm
Arm Type
Experimental
Arm Description
Patients referred for stress imaging due to complaints consistent with possible angina, randomized to receive an additional cardiac CT scan.
Arm Title
No CT Arm
Arm Type
Active Comparator
Arm Description
Patients with symptoms consistent with possible angina, randomized to receive the type of stress imaging test ordered by their physician.
Intervention Type
Procedure
Intervention Name(s)
Cardiac CT Angiography
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Stress Imaging Test (Stress Myocardial Perfusion Study or Stress Echocardiogram)
Intervention Description
Stress imaging test as ordered by the subjects provider without option for cardiac CT angiography (no CT arm)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Total number and per-patient rates of adverse cardiac events (cardiac death, myocardial infarction, unstable angina, coronary revascularization)
Time Frame
24 months
Title
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
Title
Total number and per-patient rates of subsequent outpatient + inpatient + emergency department encounters for the initial cardiac complaint
Time Frame
24 months
Title
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
Title
Change in motivation for healthy behavioral change
Time Frame
24 months
Title
Change in subject anxiety, as assessed by the State and Trait Anxiety Inventory
Time Frame
24 months
Title
Change in subject depression
Time Frame
24 months
Title
Satisfaction with diagnostic evaluation for initial complaint.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd C. Villines, M.D.
Organizational Affiliation
Walter Reed Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307
Country
United States
12. IPD Sharing Statement
Learn more about this trial
CT-FIRST: Cardiac Computed Tomography Versus Stress Imaging For Initial Risk STratification
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