Diagnostic Performances of Computed TomographIc Coronary Angiography and Intravascular Ultrasound

NCT ID: NCT01400230

Last Updated: 2015-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Diagnosis Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CCTA-IVUS-FFR

Patients suspected ischemic heart disease by the symptom and CCTA and undergone IVUS and FFR in the Cath Lab with CAG enrolled consecutively.

diagnostic procedures CCTA, CAG, IVUS and FFR

Intervention Type PROCEDURE

Diagnostic procedures including computed tomography, coronary angiography, intravascular ultrasound, fractional flow reserve were performed in the patients suspected ischemic heart disease.

Interventions

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diagnostic procedures CCTA, CAG, IVUS and FFR

Diagnostic procedures including computed tomography, coronary angiography, intravascular ultrasound, fractional flow reserve were performed in the patients suspected ischemic heart disease.

Intervention Type PROCEDURE

Other Intervention Names

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CCTA, Aquillion, Toshiba IVUS, InVision Gold, Volcano and I-Lab, Boston FFR, Pressure Wire, St.Jude medical

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

83 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inje University

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bon-Kwon Koo

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joon Hyung Doh, MD, PhD

Role: STUDY_DIRECTOR

Inje University Ilsan Paik Hospital

Bon-Kwon Koo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 20723852 (View on PubMed)

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.

Reference Type RESULT
PMID: 21481828 (View on PubMed)

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.

Reference Type RESULT
PMID: 21700253 (View on PubMed)

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.

Reference Type RESULT
PMID: 21646065 (View on PubMed)

Other Identifiers

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IB-2-1010-049

Identifier Type: -

Identifier Source: org_study_id

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