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Comparison of the Cost-Effectiveness of Coronary CT Angiography Versus Myocardial SPECT in Patients With Intermediate Risk of Coronary Heart Disease (CARE-CCTA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
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
Information provided by (Responsible Party):
Yong-Jin Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01542086
First received: February 14, 2012
Last updated: February 24, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Chest Pain
Coronary Heart Disease Risk
Procedure: Myocardial SPECT
Procedure: 64-channel coronary CT angiography (CCTA)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison of the Cost-Effectiveness of Coronary CT Angiography Versus Myocardial SPECT in Patients With Intermediate Risk of Coronary Heart Disease

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Cost-effectiveness (cost-utility) [ Time Frame: 1 Year after initial enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 1050
Study Start Date: September 2011
Arms Assigned Interventions
Active Comparator: Myocardial SPECT Procedure: Myocardial SPECT
Experimental: 64-channel coronary CT angiography (CCTA) Procedure: 64-channel coronary CT angiography (CCTA)

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01542086

Contacts
Contact: Seung-Pyo Lee, MD 82-2-2072-1980 splee0624@gmail.com
Contact: Yong-Jin Kim, MD 82-2-2072-1963 kimdamas@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Principal Investigator: Hyun-Joo Lee, MD         
Principal Investigator: Hae Ok Jung, MD         
Principal Investigator: Sang-Chol Lee, MD         
Principal Investigator: Hyuk-Jae Chang, MD         
Principal Investigator: Dae-Hee Kim, MD         
Principal Investigator: Goo Young Cho, MD         
Sponsors and Collaborators
Seoul National University Hospital
National Evidence-Based Healthcare Collaborating Agency
Seoul St. Mary's Hospital
Samsung Medical Center
Severance Hospital
Asan Medical Center
Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Yong-Jin Kim, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01542086     History of Changes
Other Study ID Numbers: H-1105-050-361
Study First Received: February 14, 2012
Last Updated: February 24, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
intermediate pre-test
probability of significant coronary heart disease

Additional relevant MeSH terms:
Chest Pain
Coronary Artery Disease
Coronary Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014