Chest PainCARE-CCTANCT01542086
Comparison of the Cost-Effectiveness of Coronary CT Angiography Versus Myocardial SPECT in Patients With Intermediate Risk of Coronary Heart Disease
A study testing Myocardial SPECT and 64-channel coronary CT angiography (CCTA) in people with Chest Pain and Coronary Heart Disease Risk, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators aim to compare the cost-effectiveness of CCTA and myocardial SPECT in patients with intermediate pre-test probability of CHD. To this end, patients with intermediate pre-test probability of CHD will be randomized 1:1 to either CCTA and myocardial SPECT. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Chest Pain, Coronary Heart Disease Risk
- What is being tested?
- Myocardial SPECT and 64-channel coronary CT angiography (CCTA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2011to not given
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be ≥30 years old and ≤80 years old.
- Subject is able to verbally confirm understandings of risks, benefits and diagnostic alternatives of receiving CCTA or SPECT.
- He/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- Subject must have intermediate probability of coronary artery disease as assessed by the appropriate criteria written below.
Who cannot join
- The patient has been previously diagnosed as having significant coronary artery disease previously (≥50% stenosis) or has previously been intervened for significant coronary artery disease (PCI or CABG).
- The patient has prior history of myocardial infarction.
- The patient has high pre-test probability of having coronary artery disease.
- The patient has history of impaired renal function, i.e. CRF or ARF.
- The patient has allergy to iodinated contrast agents.
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment), i.e. malignancy.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Hyun-Joo Lee, MD
Hae Ok Jung, MD
About this study
The investigators aim to compare the cost-effectiveness of CCTA and myocardial SPECT in patients with intermediate pre-test probability of CHD. To this end, patients with intermediate pre-test probability of CHD will be randomized 1:1 to either CCTA and myocardial SPECT. The patients will be analyzed for cost and also, for outcome.
Read the detailed description
Coronary heart disease (CHD) is the leading cause of heart failure in Westernized countries and accounts for one of the most common cause of mortality in Korea. More importantly, the nation's health cost is being more and more spent on the treatment of CHD. Therefore, selecting the right patients for intervention is becoming more and more important.
The diagnosis and treatment strategy of CHD relies on both anatomic and functional imaging. First, there should be a significant narrowing of a segment of the coronary artery and second, there must also be evidence of ischemia due to the lesion. As a consequence of the recent, rapid development and distribution of the high-resolution computed tomography (CT), physicians are referring more and more patients for anatomic imaging of the coronary vasculature with coronary CT angiography (CCTA). CCTA has the advantage of imaging the coronary arteries noninvasively that is nearly as exact as conventional, invasive coronary angiography. However, CCTA also has the possibility of overdiagnosing CHD, especially intermediate lesions. This can be important give the recent outcome of the FAME study demonstrating the inferiority of relying on only anatomic diagnosis.
In contrast, myocardial single photon emission computed tomography (SPECT) has the advantage of imaging ischemia more accurately, since it is more of a functional imaging than an anatomical imaging. However, the sensitivity and specificity is less than 80%, which means that a total of 20% of the patients can be false-negative or false-positive. In addition, although it can demonstrate ischemia, it cannot provide where and how much the coronary artery is stenotic.
Recently, van Werkhoven and Bax demonstrated that CCTA and myocardial SPECT may be complementary. The study showed that patients with both abnormal CCTA and myocardial SPECT results tend to be worse in terms of event-free survival than patients with either alone. However, the nation's cost may be too burdenful if the patients are charged with both tests together and thus, it is more critical to give information on the cost-effectiveness of both of these tests.
In this study, we aim to compare the cost-effectiveness of CCTA and myocardial SPECT in patients with intermediate pre-test probability of CHD. To this end, patients with intermediate pre-test probability of CHD will be randomized 1:1 to either CCTA and myocardial SPECT. The patients will be analyzed for cost and also, for outcome.
- Conditions
- Chest Pain, Coronary Heart Disease Risk
- Being tested
- Myocardial SPECT, 64-channel coronary CT angiography (CCTA)
- Keywords
- intermediate pre-test, probability of significant coronary heart disease
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myocardial SPECTProcedure or surgery
64-channel coronary CT angiography (CCTA)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Myocardial SPECT | Active comparator | Not described Receives: Procedure: Myocardial SPECT |
| 64-channel coronary CT angiography (CCTA) | Experimental | Not described Receives: Procedure: 64-channel coronary CT angiography (CCTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-effectiveness (cost-utility)
Measured: 1 Year after initial enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Evidence-Based Healthcare Collaborating Agency, Seoul St. Mary's Hospital, Samsung Medical Center, Severance Hospital, Asan Medical Center, Seoul National University Bundang Hospital
- Responsible party
- Principal investigator, Yong-Jin Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542086
- Sponsor's protocol ID
- H-1105-050-361
- Acronym
- CARE-CCTA
- Status last verified
- Feb 2012
- First submitted
- 14 Feb 2012
- Last updated
- 2 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Cost-Effectiveness of Coronary CT Angiography Versus Myocardial SPECT in Patients With Intermediate Risk of Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT01542086
- Acronym / sponsor ID
- CARE-CCTA / H-1105-050-361
- Conditions
- Chest Pain, Coronary Heart Disease Risk
- Keywords
- intermediate pre-test, probability of significant coronary heart disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- National Evidence-Based Healthcare Collaborating Agency, Seoul St. Mary's Hospital, Samsung Medical Center, Severance Hospital, Asan Medical Center, Seoul National University Bundang Hospital
- Study start
- Sep 2011
- First posted
- 2 Mar 2012 (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 investigators aim to compare the cost-effectiveness of CCTA and myocardial SPECT in patients with intermediate pre-test probability of CHD. To this end, patients with intermediate pre-test probability of CHD will be randomized 1:1 to either CCTA and myocardial SPECT. The patients will be analyzed for cost and also, for outcome.
Detailed description
Coronary heart disease (CHD) is the leading cause of heart failure in Westernized countries and accounts for one of the most common cause of mortality in Korea. More importantly, the nation's health cost is being more and more spent on the treatment of CHD. Therefore, selecting the right patients for intervention is becoming more and more important.
The diagnosis and treatment strategy of CHD relies on both anatomic and functional imaging. First, there should be a significant narrowing of a segment of the coronary artery and second, there must also be evidence of ischemia due to the lesion. As a consequence of the recent, rapid development and distribution of the high-resolution computed tomography (CT), physicians are referring more and more patients for anatomic imaging of the coronary vasculature with coronary CT angiography (CCTA). CCTA has the advantage of imaging the coronary arteries noninvasively that is nearly as exact as conventional, invasive coronary angiography. However, CCTA also has the possibility of overdiagnosing CHD, especially intermediate lesions. This can be important give the recent outcome of the FAME study demonstrating the inferiority of relying on only anatomic diagnosis.
In contrast, myocardial single photon emission computed tomography (SPECT) has the advantage of imaging ischemia more accurately, since it is more of a functional imaging than an anatomical imaging. However, the sensitivity and specificity is less than 80%, which means that a total of 20% of the patients can be false-negative or false-positive. In addition, although it can demonstrate ischemia, it cannot provide where and how much the coronary artery is stenotic.
Recently, van Werkhoven and Bax demonstrated that CCTA and myocardial SPECT may be complementary. The study showed that patients with both abnormal CCTA and myocardial SPECT results tend to be worse in terms of event-free survival than patients with either alone. However, the nation's cost may be too burdenful if the patients are charged with both tests together and thus, it is more critical to give information on the cost-effectiveness of both of these tests.
In this study, we aim to compare the cost-effectiveness of CCTA and myocardial SPECT in patients with intermediate pre-test probability of CHD. To this end, patients with intermediate pre-test probability of CHD will be randomized 1:1 to either CCTA and myocardial SPECT. The patients will be analyzed for cost and also, for outcome.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myocardial SPECT | Active comparator | Procedure: Myocardial SPECT |
| 64-channel coronary CT angiography (CCTA) | Experimental | Procedure: 64-channel coronary CT angiography (CCTA) |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject must be ≥30 years old and ≤80 years old.
- Subject is able to verbally confirm understandings of risks, benefits and diagnostic alternatives of receiving CCTA or SPECT.
- He/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- Subject must have intermediate probability of coronary artery disease as assessed by the appropriate criteria written below.
Key exclusion criteria (7 listed)
- The patient has been previously diagnosed as having significant coronary artery disease previously (≥50% stenosis) or has previously been intervened for significant coronary artery disease (PCI or CABG).
- The patient has prior history of myocardial infarction.
- The patient has high pre-test probability of having coronary artery disease.
- The patient has history of impaired renal function, i.e. CRF or ARF.
- The patient has allergy to iodinated contrast agents.
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 |
|---|---|---|
| Myocardial SPECT | Procedure or surgery | Myocardial SPECT |
| 64-channel coronary CT angiography (CCTA) | Procedure or surgery | 64-channel coronary CT angiography (CCTA) |
Primary outcome
Cost-effectiveness (cost-utility)
Time frame: 1 Year after initial enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myocardial SPECT and 64-channel coronary CT angiography (CCTA) in people with Chest Pain and Coronary Heart Disease Risk, run by Seoul National University Hospital at 1 site in South Korea.
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 7 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 2 Mar 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 South Korea. 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?
Contact Seung-Pyo Lee, MD (82-2-2072-1980, splee0624@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-effectiveness (cost-utility) (time frame: 1 Year after initial enrollment). 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 2 Mar 2012.