Coronary AngiographyCTSTATNCT00468325
Coronary Computed Tomography for Systematic Triage of Acute Chest Pain Patients to Treatment (CT-STAT)
A study testing Multi-slice computed tomography and Rest-stress Nuclear Myocardial Perfusion Imaging in people with Coronary Angiography and Chest Pain, run by Corewell Health East at 16 sites in United States.
Trial summary
This is a prospective, randomized multicenter trial comparing MSCT to standard of care (SOC) diagnostic treatment in the triage of Emergency Department (ED) low to intermediate risk chest pain patients. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Angiography, Chest Pain
- What is being tested?
- Multi-slice computed tomography and Rest-stress Nuclear Myocardial Perfusion Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 16 sitesUnited States
- Study dates
- May 2007to May 2009
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chest pain or anginal equivalent symptoms suggestive of acute coronary ischemia within the past 12 hours.
- TIMI risk score less than or equal to 4.
- Ability to provide informed consent.
- Age greater than or equal to 25 years.
Who cannot join
- Attending physician makes clinical decision for immediate invasive evaluation.
- Electrographic evidence of ischemia, including acute Non ST-Elevation Myocardial Infarction (NSTEMI) or ST-Elevation Myocardial Infarction (STEMI), with ST segment elevation or depression equal to or greater than 1mm in two or more contiguous leads, and/or T wave inversion greater than or equal to 2 mm.
- Positive cardiac biomarkers (troponin, CK, and/or CK-MB) compatible with AMI on initial laboratory testing, based on site standard laboratory values.
- Presence of pre-existing CAD, including prior MI, prior angiographic evidence of significant CAD, defined as greater than or equal to 25% stenosis, or history of coronary artery bypass graft (CABG) surgery.
- Renal insufficiency (creatinine greater than 1.5 mg/dL) or renal failure requiring dialysis.
- Atrial fibrillation or other markedly irregular rhythm.
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- Psychological unsuitability or extreme claustrophobia.
- Pregnancy or unknown pregnancy status.
- Clinical instability including cardiogenic shock, hypotension (systolic blood pressure <90 mmHg), refractory hypertension (systolic blood pressure >180 mmHg on therapy), sustained ventricular or atrial arrhythmia requiring intravenous medications.
- Known allergy to iodine or iodinated contrast.
- Inability to tolerate beta-blocker medication, including patients with asthma or chronic obstructive pulmonary disease (COPD) requiring maintenance, i.e. use of inhaled bronchodilators or steroids, or patients with complete heart block or second-degree atrioventricular block.
- Iodinated contrast administration or x-ray scan within the past 48 hours.
- Use of any erectile dysfunction medications such as Viagra or Cialis in the last 24 hours.
- Body Mass Index (BMI) greater than or equal to 39 kg/m2. . Use of biguanides within the past 48 hours
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Faqua Heart Center/Piedmont Hospital
Atlanta, Georgia, 30309
Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Metrohealth Medical Center
Cleveland, Ohio, 44109
Texas Heart Institute
Houston, Texas, 77030
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
Mt Sinai Hospitl
New York, New York, 10029
MultiCare Health System-Good Samaritan Hospital
Puyallup, Washington, 98371
William Beaumont Hospital
Royal Oak, Michigan, 48073
St. Paul Heart Clinic
Saint Paul, Minnesota, 55102
William Beaumont-Troy
Troy, Michigan, 48085
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Wisconsin Heart & Vascular Center
Wauwatosa, Wisconsin, 53226
Cleveland Clinic Florida
Weston, Florida, 33331
About this study
This is a prospective, randomized multicenter trial comparing MSCT to standard of care (SOC) diagnostic treatment in the triage of Emergency Department (ED) low to intermediate risk chest pain patients. Our hypotheses are that compared to SOC treatment, MSCT is equally safe and diagnostically effective, as well as more time and cost efficient.
Read the detailed description
Computed tomography (CT) or "cat scan" is an x-ray test routinely used for diagnostic purposes. Heart ("Cardiac") CT, using the newest scanners, is an improved way of looking at the coronary arteries, which supply blood to the heart muscle. If these arteries are clogged this may cause chest pain or even a heart attack. The images of the coronary arteries obtained by CT scanners (during a 5-10 minute procedure) have been shown by many studies to be accurate, when compared to the conventional invasive cardiac catheterization procedure. In addition, at least five prior studies done at different hospitals suggest that cardiac CT scans are effective for diagnosing chest pain like yours in patients coming to the emergency room. What is new about this study is that it is being done in multiple hospitals at the same time. This is part of the process that all medical advances must go through to become a part of routine care of patients in hospitals throughout the country.
A standard chest pain workup typically done in the emergency department consists of a physical examination, electrocardiograms (EKGs), and several blood tests. Blood tests typically completed include cardiac enzymes (Troponin, CK \& CK-MB), a kidney function test, a pregnancy test if applicable, and possibly a lipid panel, depending on physician preference. For each test, a 3mL vial will be filled with a specimen of blood and processed in the laboratory for result. Also a two-part "rest-stress" nuclear scan is typically performed, which compares blood flow into the heart tissue at rest to blood flow into the heart tissue during exercise or dilation with medications. Based on prior studies, the researchers doing the present study believe that CT scanning of the coronary arteries can provide information that is just as safe and accurate as the rest-stress nuclear scan, and can do so more rapidly at a lower cost.
- Conditions
- Coronary Angiography, Chest Pain
- Being tested
- Multi-slice computed tomography, Rest-stress Nuclear Myocardial Perfusion Imaging
- Keywords
- coronary artery disease, chest pain, emergency room
- Medical subject headings
- Chest Pain, Coronary Artery Disease, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-slice computed tomographyProcedure or surgery
Also called MSCT, CCTA
Patient receives a CT scan (multi-slice computed tomography) of the heart.
Rest-stress Nuclear Myocardial Perfusion ImagingProcedure or surgery
Also called MPI, Nuclear Stress Test
Patient receives the standard of care for emergency room admitting diagnosis of low to intermediate chest pain. A rest-stress nuclear myocardial perfusion imaging test is performed per the standard of care at each institution.
Multi-slice Computed TomographyProcedure or surgery
Also called CCTA, MSCT, Ct Scan of the heart
Patients admitted to the emergency department with low to intermediate chest pain receive a multi-slice computed tomographic test of the heart.
| Study group | Role | What they receive |
|---|---|---|
| Multi-slice Computed Tomography | Active comparator | Patients admitted to the ED with chest pain and/or anginal equivalent symptoms are randomized to a multi-slice computed tomography arm where they will receive a CT scan of their heart. Receives: Procedure: Multi-slice computed tomography |
| Standard of Care | Active comparator | Patients admitted to the ED with chest pain and/or anginal equivalent symptoms are randomized to the Standard of Care arm and receive rest-stress nuclear myocardial perfusion imaging test. Receives: Procedure: Rest-stress Nuclear Myocardial Perfusion Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic efficiency from the time to diagnosis and cost of diagosis for the CCTA and the Standard of Care
Measured: Time to diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2007 (estimated)
- Study startMay 2007
- Primary completionNov 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary AngiographyStudies 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
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Investigators
- Gilbert Raff, MD, Study director, Corewell Health EastKavitha Chinnaiyan, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468325
- Sponsor's protocol ID
- 2007-016
- Acronym
- CTSTAT
- Status last verified
- Nov 2009
- First submitted
- 30 Apr 2007
- Last updated
- 16 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Goldstein JA, Chinnaiyan KM, Abidov A, Achenbach S, Berman DS, Hayes SW, Hoffmann U, Lesser JR, Mikati IA, O'Neil BJ, Shaw LJ, Shen MY, Valeti US, Raff GL; CT-STAT Investigators. The CT-STAT (Coronary Computed Tomographic Angiography for Systematic Triage of Acute Chest Pain Patients to Treatment) trial. J Am Coll Cardiol. 2011 Sep 27;58(14):1414-22. doi: 10.1016/j.jacc.2011.03.068.
PubMed 21939822
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Computed Tomography for Systematic Triage of Acute Chest Pain Patients to Treatment (CT-STAT)
- ClinicalTrials.gov ID
- NCT00468325
- Acronym / sponsor ID
- CTSTAT / 2007-016
- Conditions
- Coronary Angiography, Chest Pain
- Keywords
- coronary artery disease, chest pain, emergency room
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 2 May 2007 (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.
This is a prospective, randomized multicenter trial comparing MSCT to standard of care (SOC) diagnostic treatment in the triage of Emergency Department (ED) low to intermediate risk chest pain patients. Our hypotheses are that compared to SOC treatment, MSCT is equally safe and diagnostically effective, as well as more time and cost efficient.
Detailed description
Computed tomography (CT) or "cat scan" is an x-ray test routinely used for diagnostic purposes. Heart ("Cardiac") CT, using the newest scanners, is an improved way of looking at the coronary arteries, which supply blood to the heart muscle. If these arteries are clogged this may cause chest pain or even a heart attack. The images of the coronary arteries obtained by CT scanners (during a 5-10 minute procedure) have been shown by many studies to be accurate, when compared to the conventional invasive cardiac catheterization procedure. In addition, at least five prior studies done at different hospitals suggest that cardiac CT scans are effective for diagnosing chest pain like yours in patients coming to the emergency room. What is new about this study is that it is being done in multiple hospitals at the same time. This is part of the process that all medical advances must go through to become a part of routine care of patients in hospitals throughout the country.
A standard chest pain workup typically done in the emergency department consists of a physical examination, electrocardiograms (EKGs), and several blood tests. Blood tests typically completed include cardiac enzymes (Troponin, CK \& CK-MB), a kidney function test, a pregnancy test if applicable, and possibly a lipid panel, depending on physician preference. For each test, a 3mL vial will be filled with a specimen of blood and processed in the laboratory for result. Also a two-part "rest-stress" nuclear scan is typically performed, which compares blood flow into the heart tissue at rest to blood flow into the heart tissue during exercise or dilation with medications. Based on prior studies, the researchers doing the present study believe that CT scanning of the coronary arteries can provide information that is just as safe and accurate as the rest-stress nuclear scan, and can do so more rapidly at a lower cost.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-slice Computed Tomography | Active comparator | Procedure: Multi-slice computed tomographyPatients admitted to the ED with chest pain and/or anginal equivalent symptoms are randomized to a multi-slice computed tomography arm where they will receive a CT scan of their heart. |
| Standard of Care | Active comparator | Procedure: Rest-stress Nuclear Myocardial Perfusion ImagingPatients admitted to the ED with chest pain and/or anginal equivalent symptoms are randomized to the Standard of Care arm and receive rest-stress nuclear myocardial perfusion imaging test. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chest pain or anginal equivalent symptoms suggestive of acute coronary ischemia within the past 12 hours.
- TIMI risk score less than or equal to 4.
- Ability to provide informed consent.
- Age greater than or equal to 25 years.
Key exclusion criteria (14 listed)
- Attending physician makes clinical decision for immediate invasive evaluation.
- Electrographic evidence of ischemia, including acute Non ST-Elevation Myocardial Infarction (NSTEMI) or ST-Elevation Myocardial Infarction (STEMI), with ST segment elevation or depression equal to or greater than 1mm in two or more contiguous leads, and/or T wave inversion greater than or equal to 2 mm.
- Positive cardiac biomarkers (troponin, CK, and/or CK-MB) compatible with AMI on initial laboratory testing, based on site standard laboratory values.
- Presence of pre-existing CAD, including prior MI, prior angiographic evidence of significant CAD, defined as greater than or equal to 25% stenosis, or history of coronary artery bypass graft (CABG) surgery.
- Renal insufficiency (creatinine greater than 1.5 mg/dL) or renal failure requiring dialysis.
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 |
|---|---|---|
| Multi-slice computed tomographyAlso: MSCT, CCTAPatient receives a CT scan (multi-slice computed tomography) of the heart. | Procedure or surgery | Multi-slice Computed Tomography |
| Rest-stress Nuclear Myocardial Perfusion ImagingAlso: MPI, Nuclear Stress TestPatient receives the standard of care for emergency room admitting diagnosis of low to intermediate chest pain. A rest-stress nuclear myocardial perfusion imaging test is performed per the standard of care at each institution. | Procedure or surgery | Standard of Care |
| Multi-slice Computed TomographyAlso: CCTA, MSCT, Ct Scan of the heartPatients admitted to the emergency department with low to intermediate chest pain receive a multi-slice computed tomographic test of the heart. | Procedure or surgery | Multi-slice Computed Tomography |
Primary outcome
Diagnostic efficiency from the time to diagnosis and cost of diagosis for the CCTA and the Standard of Care
Time frame: Time to diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2009.
- Derived from this study: PubMed 21939822Goldstein JA, Chinnaiyan KM, Abidov A, Achenbach S, Berman DS, Hayes SW, Hoffmann U, Lesser JR, Mikati IA, O'Neil BJ, Shaw LJ, Shen MY, Valeti US, Raff GL; CT-STAT Investigators. The CT-STAT (Coronary Computed Tomographic Angiography for Systematic Triage of Acute Chest Pain Patients to Treatment) trial. J Am Coll Cardiol. 2011 Sep 27;58(14):1414-22. doi: 10.1016/j.jacc.2011.03.068.
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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.
Gilbert Raff, MD study director
Corewell Health East
Kavitha Chinnaiyan, MD principal investigator
Corewell Health East
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-slice computed tomography and Rest-stress Nuclear Myocardial Perfusion Imaging in people with Coronary Angiography and Chest Pain, run by Corewell Health East at 16 sites 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 4 inclusion and 14 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: finished, as of the sponsor's last update on 16 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic efficiency from the time to diagnosis and cost of diagosis for the CCTA and the Standard of Care (time frame: Time to diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00468325, which also lists 1 linked publication.
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 16 Nov 2009.