Comparison of the Cost-Effectiveness of Coronary CT Angiography Versus Myocardial SPECT in Patients With Intermediate Risk of Coronary Heart Disease
CARE-CCTA
1 other identifier
interventional
1,050
1 country
1
Brief 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. The patients will be analyzed for cost and also, for outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 14, 2012
CompletedFirst Posted
Study publicly available on registry
March 2, 2012
CompletedMarch 2, 2012
February 1, 2012
February 14, 2012
February 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cost-effectiveness (cost-utility)
1 Year after initial enrollment
Study Arms (2)
Myocardial SPECT
ACTIVE COMPARATOR64-channel coronary CT angiography (CCTA)
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- National Evidence-Based Healthcare Collaborating Agencycollaborator
- Seoul St. Mary's Hospitalcollaborator
- Samsung Medical Centercollaborator
- Severance Hospitalcollaborator
- Asan Medical Centercollaborator
- Seoul National University Bundang Hospitalcollaborator
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 14, 2012
First Posted
March 2, 2012
Study Start
September 1, 2011
Last Updated
March 2, 2012
Record last verified: 2012-02