Diagnostic Performances of Computed TomographIc Coronary Angiography and Intravascular Ultrasound

Completed

• Conditions: Diagnosis Coronary Artery Disease
• Interventions: Procedure: diagnostic procedures CCTA, CAG, IVUS and FFR

• Registration Number: NCT01400230
• Lead Sponsor: Seoul National University Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2011-07-15
• Study First Submitted QC: 2011-07-20
• Study First Posted: 2011-07-22
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-23
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CCTA-IVUS-FFR	diagnostic procedures CCTA, CAG, IVUS and FFR	Patients suspected ischemic heart disease by the symptom and CCTA and undergone IVUS and FFR in the Cath Lab with CAG enrolled consecutively.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy	1 day	Evaluate and compare the diagnostic accuracy of the CCTA, IVUS and angiographic parameters for the prediction of myocardial ischemia (FFR\<0.8); 1. CCTA: % area stenosis; 2. IVUS: minimum lumen area; 3. Angiography: % diameter stenosis; Diagnostic accuracy of each parameter: (true positive+true negative)/total cases

Trial Locations

Locations (1)

Inje University Ilsan Paik Hospital; 🇰🇷 Goyang, Gyeonggi-do, Korea, Republic of