Clinical trial NCT01400230: Diagnostic Performances of Computed TomographIc Coronary Angiography and Intravascular Ultrasound
Official title: Diagnostic Performances of the Computed Tomographic Coronary Angiography and IntraVascular UltraSound to Evaluate Ischemia Causing Coronary Artery Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diagnosis Coronary Artery Disease
Keywords: computed tomography
intravascular ultrasound
coronary stenosis
fractional flow reserve
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Inje University
First posted: 2011-07-22
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients who underwent CCTA, IVUS and FFR Stable clinical condition

Brief summary: Diagnostic purposes of the coronary angiography is to detect stenosis (anatomy) and to detect ischemia related stenosis (function). Coronary angiography (CAG) is a gold standard invasive techniques, but has several limitations. Intravascular ultrasound (IVUS) provides tomographic intra-luminal images. Coronary computed tomographic angiography (CCTA) is helpful to assess precise anatomical information. Optimal functional criteria and their accuracy of IVUS and CCTA by fraction flow reserve (FFR) have not been compared yet.

Detailed description: Correlation between CCTA, IVUS and FFR will be evaluated. The presence of myocardial ischemia will be assessed by fractional flow reserve (FFR).

Diagnostic performance (sensitivity, specificity, positive predictive/negative predictive values and diagnostic accuracy) of each modality will be assessed and compared.

Eligibility criteria: Inclusion Criteria:

* patients presenting chest pain suspected stable angina or unstable angina
* patients permit informed consents
* patients performed all the procedures including CCTA, IVUS and FFR and present coronary artery stenosis

Exclusion Criteria:

* acute myocardial infarction
* ejection fraction less than 40%
* infarct related artery
* chronic renal insufficiency
* left main stenosis, in-stent restenosis and grafted vessels
* allergy in contrast agent and adenosine
* unable to get a informed consents

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Gyeonggi-do
Study officials:
affiliation: Inje University Ilsan Paik Hospital
name: Joon Hyung Doh, MD, PhD
role: STUDY_DIRECTOR
affiliation: Seoul National University Hospital
name: Bon-Kwon Koo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nam CW, Yoon HJ, Cho YK, Park HS, Kim H, Hur SH, Kim YN, Chung IS, Koo BK, Tahk SJ, Fearon WF, Kim KB. Outcomes of percutaneous coronary intervention in intermediate coronary artery disease: fractional flow reserve-guided versus intravascular ultrasound-guided. JACC Cardiovasc Interv. 2010 Aug;3(8):812-7. doi: 10.1016/j.jcin.2010.04.016.
citation: Nam CW, Hur SH, Cho YK, Park HS, Yoon HJ, Kim H, Chung IS, Kim YN, Kim KB, Doh JH, Koo BK, Tahk SJ, Fearon WF. Relation of fractional flow reserve after drug-eluting stent implantation to one-year outcomes. Am J Cardiol. 2011 Jun 15;107(12):1763-7. doi: 10.1016/j.amjcard.2011.02.329. Epub 2011 Apr 8.
citation: Ahn JM, Kang SJ, Mintz GS, Oh JH, Kim WJ, Lee JY, Park DW, Lee SW, Kim YH, Lee CW, Park SW, Moon DH, Park SJ. Validation of minimal luminal area measured by intravascular ultrasound for assessment of functionally significant coronary stenosis comparison with myocardial perfusion imaging. JACC Cardiovasc Interv. 2011 Jun;4(6):665-71. doi: 10.1016/j.jcin.2011.02.013.
citation: Ben-Dor I, Torguson R, Gaglia MA Jr, Gonzalez MA, Maluenda G, Bui AB, Xue Z, Satler LF, Suddath WO, Lindsay J, Pichard AD, Waksman R. Correlation between fractional flow reserve and intravascular ultrasound lumen area in intermediate coronary artery stenosis. EuroIntervention. 2011 Jun;7(2):225-33. doi: 10.4244/EIJV7I2A37.