Coronary Artery DiseaseCT-FIRSTNCT01061398
CT-FIRST: Cardiac Computed Tomography Versus Stress Imaging For Initial Risk STratification
A study testing Cardiac CT Angiography and Stress Imaging Test (Stress Myocardial Perfusion Study or Stress Echocardiogram) in people with Coronary Artery Disease and Chest Pain, run by Walter Reed Army Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronary Artery Disease, Chest Pain, Coronary Atherosclerosis
- What is being tested?
- Cardiac CT Angiography and Stress Imaging Test (Stress Myocardial Perfusion Study or Stress Echocardiogram)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
About this study
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.
Read the 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.
- Being tested
- Cardiac CT Angiography, Stress Imaging Test (Stress Myocardial Perfusion Study or Stress Echocardiogram)
- Keywords
- cardiac ct, stress testing, coronary artery disease
- Medical subject headings
- Coronary Artery Disease, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac CT AngiographyProcedure or surgery
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
Stress Imaging Test (Stress Myocardial Perfusion Study or Stress Echocardiogram)Procedure or surgery
Stress imaging test as ordered by the subjects provider without option for cardiac CT angiography (no CT arm)
| Study group | Role | What they receive |
|---|---|---|
| Cardiac CT Arm | Experimental | Patients referred for stress imaging due to complaints consistent with possible angina, randomized to receive an additional cardiac CT scan. Receives: Procedure: Cardiac CT Angiography |
| No CT Arm | Active comparator | Patients with symptoms consistent with possible angina, randomized to receive the type of stress imaging test ordered by their physician. Receives: Procedure: Stress Imaging Test (Stress Myocardial Perfusion Study or Stress Echocardiogram) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 months
Secondary outcomes (8)
Total number and per-patient rates of adverse cardiac events (cardiac death, myocardial infarction, unstable angina, coronary revascularization)
Measured: 24 months
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
Measured: 24 months
Total number and per-patient rates of subsequent outpatient + inpatient + emergency department encounters for the initial cardiac complaint
Measured: 24 months
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.
Measured: 24 months
Change in motivation for healthy behavioral change
Measured: 24 months
Change in subject anxiety, as assessed by the State and Trait Anxiety Inventory
Measured: 24 months
Change in subject depression
Measured: 24 months
Satisfaction with diagnostic evaluation for initial complaint.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startNov 2007
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Todd C. Villines, Walter Reed National Military Medical Center
- Investigators
- Todd C. Villines, M.D., Principal investigator, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061398
- Sponsor's protocol ID
- WU#08-12032
- Acronym
- CT-FIRST
- Status last verified
- Jun 2012
- First submitted
- 2 Feb 2010
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT-FIRST: Cardiac Computed Tomography Versus Stress Imaging For Initial Risk STratification
- ClinicalTrials.gov ID
- NCT01061398
- Acronym / sponsor ID
- CT-FIRST / WU#08-12032
- Keywords
- cardiac ct, stress testing, coronary artery disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Study start
- Nov 2007
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 3 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac CT Arm | Experimental | Procedure: Cardiac CT AngiographyPatients referred for stress imaging due to complaints consistent with possible angina, randomized to receive an additional cardiac CT scan. |
| No CT Arm | Active comparator | Procedure: Stress Imaging Test (Stress Myocardial Perfusion Study or Stress Echocardiogram)Patients with symptoms consistent with possible angina, randomized to receive the type of stress imaging test ordered by their physician. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac CT AngiographyPatients randomized to CT Arm will undergo 64-slice cardiac CT angiography (single scan) in addition to the stress imaging test ordered by their physician | Procedure or surgery | Cardiac CT Arm |
| 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) | Procedure or surgery | No CT Arm |
Primary outcome
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
8 secondary outcomes
Total number and per-patient rates of adverse cardiac events (cardiac death, myocardial infarction, unstable angina, coronary revascularization)
Time frame: 24 months
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
Total number and per-patient rates of subsequent outpatient + inpatient + emergency department encounters for the initial cardiac complaint
Time frame: 24 months
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
Change in motivation for healthy behavioral change
Time frame: 24 months
Change in subject anxiety, as assessed by the State and Trait Anxiety Inventory
Time frame: 24 months
Change in subject depression
Time frame: 24 months
Satisfaction with diagnostic evaluation for initial complaint.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd C. Villines, M.D. principal investigator
Walter Reed Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac CT Angiography and Stress Imaging Test (Stress Myocardial Perfusion Study or Stress Echocardiogram) in people with Coronary Artery Disease and Chest Pain, run by Walter Reed Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2012.