Acute Coronary SyndromePhase 3CCTANCT00473863
Coronary Computed Tomographic Angiography in Emergency Department Chest Pain Patients at Intermediate Risk of Acute Coronary Syndrome
A Phase 3 study testing Coronary Computed Tomographic Angiography in people with Acute Coronary Syndrome and Acute Myocardial Infarction, run by Vancouver General Hospital at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether Coronary Computed Tomographic Angiography (CCTA) will increase patient safety by decreasing the rate of missed ACS and adverse events in patients who receive standard care plus CCTA versus standard care alone. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Acute Myocardial Infarction, Unstable Angina
- What is being tested?
- Coronary Computed Tomographic Angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to Jul 2008
- Phase
- Phase 3
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anterior or lateral chest pain
- 19 years of age or older
- Fixed address in British Columbia
- Available for telephone follow-up
Who cannot join
- Low Risk for ACS (all of the following):
- Age < 40 years with normal ECG (T wave flattening is the only acceptable abnormality)
- No prior history of ischemic chest pain (defined as a past diagnosis of MI or angina, previously prescribed nitroglycerine or a clear history of effort related angina)
- High Risk for ACS (any of the following):
- Diagnosis consistent with ST elevation myocardial infarction
- New ST depression ≥ 0.05 mV
Show all 20Show fewer
- Troponin > 0.1
- Patients with Killip class III or IV heart failure.
- Hemodynamic instability
- Previous enrolment in this study.
- Presence of terminal noncardiac illness.
- History of angioplasty with stenting and/or grafts.
- Presence of atrial fibrillation.
- Contraindication to administration of iodinated contrast agent.
- Contraindication to beta-blocker administration (eg, asthmatics) AND calcium channel blocker administration.
- Glomerular filtration rate less than 60 mL/min.
- Previous ECG-gated CT with calcium score >1000 Agatston Units.
- Pregnancy.
- Patients with communication difficulties.
- Patients who have a clear alternative diagnosis other than ischemic chest pain (e.g. traumatic chest pain or pneumonia).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
VGH
Vancouver, British Columbia, V5Z1M9
William Dick, MD, 604 875 4700, william.dick@vch.ca
James KH Woo, MD BSc
About this study
The purpose of this study is to determine whether Coronary Computed Tomographic Angiography (CCTA) will increase patient safety by decreasing the rate of missed ACS and adverse events in patients who receive standard care plus CCTA versus standard care alone. Additional goals of the study are to determine whether CCTA can safely reduce the duration of ED visits and the number and duration of hospital admissions.
Read the detailed description
Justification:
Acute coronary syndrome (ACS) is the clinical manifestation of acute myocardial ischemia induced by coronary artery disease (CAD). Although most patients presenting with chest pain to the Emergency Department (ED) can be stratified into "high risk" or "low risk" chest pain algorithms, patients at "intermediate risk" are more difficult to manage. This translates into lengthy waits in the ED and repetitive investigations while 5.3% of cases of ACS are still missed and too many patients are admitted to the CCU (false positive rate of 14%). CCTA is a novel, non-invasive method for evaluating coronary artery stenosis and occlusion.
The ability to accurately diagnose or exclude ACS in patients in a rapid, non-invasive fashion has been previously lacking. If CCTA is shown to be clinically useful in risk stratification of this patient population, there is great potential for increasing patient safety, reducing ED admission times and decreasing the number and duration of CCU admission.
Objectives:
ED admission and discharge times, CCU consult and decision times and duration of CCU admission, cardiac risk factors, vital signs, laboratory results, ED disposition plan, CCTA results, coronary calcium score, index hospitalization diagnosis, investigations, revascularization rates as well as 30-day diagnosis, death, adverse event rate and subsequent investigations.
Research Method:
The study population will consist of ED chest pain patients at intermediate risk of ACS. Informed consent will be obtained for both CCTA and the 30-day follow up. Patients will be randomized into one of two diagnostic arms: standard care plus CCTA versus standard care alone. If the patient receives CCTA, the test will be interpreted by a blinded radiologist and the results provided to the ED physician and entered into the patient chart. A research nurse will collect workflow and clinical data for all enrolled patients.
Two reviewers, an ED physician and a cardiologist, blinded to the CCTA results, will independently review the index and 30 day clinical data. One of the following will be assigned: acute myocardial infarction, definite unstable angina, possible unstable angina, or no acute coronary syndrome. Alternate non-ACS diagnoses will be ascertained when applicable.
Statistical Analysis This proposal represents a pilot study to demonstrate the feasibility of identifying and recruiting patients to the trial, demonstrate the feasibility of collecting follow-up data, and provide preliminary estimates of outcome measures to help determine the sample size required for a definitive study. All analyses will be descriptive. Recruitment, crossover, follow-up, and completion rates will be determined. Estimates of diagnostic accuracy and length of stay in the ED will be determined and will be used to inform the design of the definitive study.
- Conditions
- Acute Coronary Syndrome, Acute Myocardial Infarction, Unstable Angina, Coronary Disease, Coronary Stenosis
- Being tested
- Coronary Computed Tomographic Angiography
- Keywords
- Acute coronary syndrome, Acute myocardial infarction, Unstable angina, Coronary computed tomographic angiography, Coronary Angiography, Tomography, X-Ray Computed, Tomography, Spiral Computed
- Medical subject headings
- Acute Coronary Syndrome, Angina, Unstable, Coronary Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Computed Tomographic AngiographyProcedure or surgery
CCTA will be performed
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Receives CCTA Receives: Procedure: Coronary Computed Tomographic Angiography |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency Department Admission Time
Measured: During initial presentation to hospital
Secondary outcomes (5)
CCU consult time
Measured: During initial presentation to hospital
CCU decision time
Measured: During initial presentation to hospital
Duration of CCU admission
Measured: During initial presentation to hospital
Adverse event rate
Measured: 30 days post ED visit
All-cause mortality
Measured: 30 days post-ED visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2007 (estimated)
- Study startNov 2007
- Study completionJul 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vancouver General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Investigators
- William F Dick, MD, Principal investigator, Vancouver General HospitalJohn Mayo, MD, Study director, Vancouver General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473863
- Sponsor's protocol ID
- H07-00742
- Acronym
- CCTA
- Status last verified
- Nov 2007
- First submitted
- 15 May 2007
- Last updated
- 20 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Computed Tomographic Angiography in Emergency Department Chest Pain Patients at Intermediate Risk of Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT00473863
- Acronym / sponsor ID
- CCTA / H07-00742
- Conditions
- Acute Coronary Syndrome, Acute Myocardial Infarction, Unstable Angina, Coronary Disease, Coronary Stenosis
- Keywords
- Acute coronary syndrome, Acute myocardial infarction, Unstable angina, Coronary computed tomographic angiography, Coronary Angiography, Tomography, X-Ray Computed, Tomography, Spiral Computed
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Vancouver General HospitalUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- Nov 2007
- Study completion
- Jul 2008 (estimated)
- First posted
- 16 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.
The purpose of this study is to determine whether Coronary Computed Tomographic Angiography (CCTA) will increase patient safety by decreasing the rate of missed ACS and adverse events in patients who receive standard care plus CCTA versus standard care alone. Additional goals of the study are to determine whether CCTA can safely reduce the duration of ED visits and the number and duration of hospital admissions.
Detailed description
Justification:
Acute coronary syndrome (ACS) is the clinical manifestation of acute myocardial ischemia induced by coronary artery disease (CAD). Although most patients presenting with chest pain to the Emergency Department (ED) can be stratified into "high risk" or "low risk" chest pain algorithms, patients at "intermediate risk" are more difficult to manage. This translates into lengthy waits in the ED and repetitive investigations while 5.3% of cases of ACS are still missed and too many patients are admitted to the CCU (false positive rate of 14%). CCTA is a novel, non-invasive method for evaluating coronary artery stenosis and occlusion.
The ability to accurately diagnose or exclude ACS in patients in a rapid, non-invasive fashion has been previously lacking. If CCTA is shown to be clinically useful in risk stratification of this patient population, there is great potential for increasing patient safety, reducing ED admission times and decreasing the number and duration of CCU admission.
Objectives:
ED admission and discharge times, CCU consult and decision times and duration of CCU admission, cardiac risk factors, vital signs, laboratory results, ED disposition plan, CCTA results, coronary calcium score, index hospitalization diagnosis, investigations, revascularization rates as well as 30-day diagnosis, death, adverse event rate and subsequent investigations.
Research Method:
The study population will consist of ED chest pain patients at intermediate risk of ACS. Informed consent will be obtained for both CCTA and the 30-day follow up. Patients will be randomized into one of two diagnostic arms: standard care plus CCTA versus standard care alone. If the patient receives CCTA, the test will be interpreted by a blinded radiologist and the results provided to the ED physician and entered into the patient chart. A research nurse will collect workflow and clinical data for all enrolled patients.
Two reviewers, an ED physician and a cardiologist, blinded to the CCTA results, will independently review the index and 30 day clinical data. One of the following will be assigned: acute myocardial infarction, definite unstable angina, possible unstable angina, or no acute coronary syndrome. Alternate non-ACS diagnoses will be ascertained when applicable.
Statistical Analysis This proposal represents a pilot study to demonstrate the feasibility of identifying and recruiting patients to the trial, demonstrate the feasibility of collecting follow-up data, and provide preliminary estimates of outcome measures to help determine the sample size required for a definitive study. All analyses will be descriptive. Recruitment, crossover, follow-up, and completion rates will be determined. Estimates of diagnostic accuracy and length of stay in the ED will be determined and will be used to inform the design of the definitive study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Procedure: Coronary Computed Tomographic AngiographyReceives CCTA |
| Control | No intervention | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Anterior or lateral chest pain
- 19 years of age or older
- Fixed address in British Columbia
- Available for telephone follow-up
Key exclusion criteria (20 listed)
- Low Risk for ACS (all of the following):
- Age < 40 years with normal ECG (T wave flattening is the only acceptable abnormality)
- No prior history of ischemic chest pain (defined as a past diagnosis of MI or angina, previously prescribed nitroglycerine or a clear history of effort related angina)
- High Risk for ACS (any of the following):
- Diagnosis consistent with ST elevation myocardial infarction
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 |
|---|---|---|
| Coronary Computed Tomographic AngiographyCCTA will be performed | Procedure or surgery | intervention |
Primary outcome
Emergency Department Admission Time
Time frame: During initial presentation to hospital
5 secondary outcomes
CCU consult time
Time frame: During initial presentation to hospital
CCU decision time
Time frame: During initial presentation to hospital
Duration of CCU admission
Time frame: During initial presentation to hospital
Adverse event rate
Time frame: 30 days post ED visit
All-cause mortality
Time frame: 30 days post-ED visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2007.
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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.
William F Dick, MD principal investigator
Vancouver General Hospital
John Mayo, MD study director
Vancouver General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Coronary Computed Tomographic Angiography in people with Acute Coronary Syndrome and Acute Myocardial Infarction, run by Vancouver General Hospital at 1 site in Canada.
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 20 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 20 Nov 2007. 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 Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact William F Dick, MD (604 875 4700, william.dick@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergency Department Admission Time (time frame: During initial presentation to hospital). 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 20 Nov 2007.